HK40012953A - Multi-factor control of ear stimulation - Google Patents

Description

Multifactorial control of ear stimulation

All subject matter of the priority application is incorporated herein by reference to the extent such subject matter is not inconsistent herewith.

Disclosure of Invention

In one aspect, neurostimulation systems include, but are not limited to: a neural signal sensor adapted to sense a neural signal from a subject, the neural signal being indicative of a physiological state of the subject; a neural stimulator adapted to generate a stimulus in response to the sensed neural signal, the stimulus configured to activate at least one sensory nerve fiber that innervates at least a portion of a pinna of the subject; and a fixation member configured to fix the neurostimulator to the pinna. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method includes, but is not limited to: sensing a neural signal indicative of a physiological state of a subject with a neural signal sensor located in or on a portion of the subject's body; determining, with a signal analysis circuit, at least one parameter of the sensed neural signal; and delivering neural stimulation with a neural stimulation device worn on a pinna of the subject in response to the sensed neural signal, wherein the neural stimulation is configured to modulate activity of at least one sensory nerve fiber that innervates at least a portion of the pinna of the subject. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

A wearable neurostimulation device includes, but is not limited to: a vibromechanical stimulator adapted to generate vibro-stimulation having a sufficient frequency and amplitude to modulate the activity of at least one mechanoreceptor having a receptive field on at least a portion of a pinna of a subject; and a securing member configured to secure the vibrating mechanical stimulator to the pinna. In addition to the foregoing, other apparatus aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method includes, but is not limited to: delivering vibromechanical stimulation to at least a portion of a pinna of a subject with a neural stimulation device worn on the pinna of the subject, wherein the vibromechanical stimulation has a sufficient frequency and amplitude to modulate activity of at least one mechanoreceptor having a receptive field on at least a portion of the pinna. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a neurostimulation system includes, but is not limited to, a wearable neurostimulation device and a personal computing device, the wearable neurostimulation device comprising: a neurostimulator adapted to generate stimulation for activating at least one sensory nerve fiber that innervates at least a portion of a pinna of a subject; a fixation member configured to fix the neurostimulator to the pinna; a control circuit incorporated into the wearable neurostimulation device for controlling operation of the neurostimulator; and a first communication circuit incorporated into the wearable neurostimulation device and operatively connected to the control circuit, the first communication circuit configured for at least one of sending signals to and receiving signals from a personal computing device; and the personal computing device comprises: a user interface for at least one of presenting information to a user and receiving information from a user; a control circuit operatively connected to the user interface; a second communication circuit configured for at least one of transmitting and receiving signals to and from the first communication circuit; and instructions that, when executed on a personal computing device, cause the personal computing device to perform at least one of sending and receiving signals to and from the wearable neural stimulation device via the second communication circuit. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a system includes, but is not limited to, a personal computing device comprising: circuitry for receiving a neural activity signal indicative of a physiological state of a subject; circuitry for determining a neural stimulation control signal based at least in part on the neural activity signal; and circuitry for outputting the neural stimulation control signal to a neural stimulation device, the neural stimulation device comprising an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulation control signal is configured to control delivery of neural stimulation by the external neural stimulator, the neural stimulation configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method includes, but is not limited to: receiving, at a personal computing device, a physiological activity signal indicative of a physiological state of a subject; determining a neural stimulation control signal based at least in part on the physiological activity signal; outputting the neurostimulation control signal from the personal computing device to a neurostimulation device comprising an external neurostimulator configured to be carried on a pinna of the subject, wherein the neurostimulation control signal is configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber that innervates at least a portion of the pinna. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a computer program product includes, but is not limited to: a non-transitory signal bearing medium bearing: one or more instructions for receiving a neural activity signal indicative of a physiological state of a subject; one or more instructions for determining a neural stimulation control signal based at least in part on the neural activity signal; and one or more instructions for outputting the neurostimulation control signal to a neurostimulation device, the neurostimulation device comprising an external neurostimulator configured to be carried on a pinna of the subject, wherein the neurostimulation control signal is configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber that innervates at least a portion of the pinna. In addition to the foregoing, other aspects of a computer program product are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method includes, but is not limited to: receiving, at a personal computing device, a physiological activity signal indicative of a physiological state of a subject; determining a neural stimulation control signal based at least in part on the physiological activity signal; outputting the neurostimulation control signal from the personal computing device to a neurostimulation device comprising an external neurostimulator configured to be carried on a pinna of the subject, wherein the neurostimulation control signal is configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber that innervates at least a portion of a pinna; and presenting information to the subject via a user interface. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a system includes, but is not limited to, a personal computing device comprising: circuitry for receiving, at a personal computing device, a physiological activity signal indicative of a physiological state of a subject; circuitry for determining a neural stimulation control signal based at least in part on the physiological activity signal, the neural stimulation control signal configured to control delivery of neural stimulation by the external neural stimulator, the neural stimulation configured to activate at least one sensory nerve fiber innervating at least a portion of a pinna; circuitry for outputting the neurostimulation control signals from the personal computing device to a neurostimulation device comprising an external neurostimulator configured to be carried on a pinna of the subject; and circuitry for presenting information to the subject via a user interface. In addition to the foregoing, other personal computing device aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, the computer program product includes, but is not limited to: a non-transitory signal bearing medium bearing: one or more instructions for receiving a physiological activity signal indicative of a physiological state of a subject; one or more instructions for determining a neural stimulation control signal based at least in part on the physiological activity signal; one or more instructions for outputting the neurostimulation control signal to a neurostimulation device, the neurostimulation device comprising an external neurostimulator configured to be carried on an ear of a subject, wherein the neurostimulation control signal is configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber that innervates at least a portion of the pinna; and one or more instructions for presenting information to the subject via a user interface. In addition to the foregoing, other computer program product aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a system includes, but is not limited to, a personal computing device comprising: circuitry for receiving, at a personal computing device, a physiological activity signal indicative of a physiological state of a subject; circuitry for determining a neural stimulation control signal based at least in part on the physiological activity signal; circuitry for outputting the neurostimulation control signals from the personal computing device to a neurostimulation device comprising an external neurostimulator configured to be carried on a pinna of the subject, wherein the neurostimulation control signals are configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, and circuitry for outputting audio output signals via audio output of the personal computing device. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method includes, but is not limited to: receiving, at a personal computing device, a physiological activity signal indicative of a physiological state of a subject; determining a neural stimulation control signal based at least in part on the physiological activity signal; outputting the neural stimulation control signal from the personal computing device to a neural stimulation device, the neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulation control signal is configured to control delivery of neural stimulation by the external neural stimulator, the neural stimulation configured to activate at least one sensory nerve fiber that innervates at least a portion of the pinna, and output an audio output signal via an audio output of the personal computing device. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, the computer program product includes, but is not limited to: a non-transitory signal bearing medium bearing: one or more instructions for receiving, at a personal computing device, a physiological activity signal indicative of a physiological state of a subject; one or more instructions for determining a neural stimulation control signal based at least in part on the physiological activity signal; one or more instructions for outputting the neurostimulation control signals from the personal computing device to a neurostimulation device comprising an external neurostimulator configured to be carried on an auricle of the subject, wherein the neurostimulation control signals are configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber that innervates at least a portion of the auricle; and one or more instructions for outputting an audio output signal via an audio output of the personal computing device. In addition to the foregoing, other computer program product aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method includes, but is not limited to: determining, with a stimulus control circuit in a personal computing device, a vibration stimulus control signal; and outputting the vibration stimulation control signal from the personal computing device to a wearable mechanical stimulation device, the wearable mechanical stimulation device including a vibration mechanical stimulator configured to be carried on a pinna of a subject, wherein the vibration stimulation control signal is configured to control delivery of vibration stimulation by the vibration mechanical stimulator, the vibration stimulation configured to activate at least one mechanoreceptor having a receptive field over at least a portion of the pinna. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a system includes, but is not limited to, a personal computing device comprising: circuitry for determining a vibration stimulus control signal; and circuitry for outputting the vibration stimulation control signal to a wearable mechanical stimulation device, the wearable mechanical stimulation device comprising a vibration mechanical stimulator configured to be carried on a pinna of a subject, wherein the vibration stimulation control signal is configured to control delivery of vibration stimulation by the vibration mechanical stimulator, the vibration stimulation configured to activate at least one mechanoreceptor having a receptive field on at least a portion of the pinna. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a computer program product includes, but is not limited to, a non-transitory signal bearing medium bearing: one or more instructions for determining a vibration stimulation control signal configured to control delivery of vibration stimulation by a vibrating mechanical stimulator, the vibration stimulation configured to activate at least one mechanoreceptor having a receptive field on at least a portion of a pinna of a subject; and one or more instructions for outputting the vibration stimulation control signal to a wearable mechanical stimulation device, the wearable mechanical stimulation device comprising at least one vibration mechanical stimulator. In addition to the foregoing, other computer program product aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method includes, but is not limited to: receiving, at a computing system, identification information identifying at least one of a subject and a neurostimulation device associated with the subject, the neurostimulation device configured to be carried on an ear of a subject and comprising an external neurostimulator; and communicating a recommendation relating to a treatment regimen from the computing system to a personal computing device used by the subject, the treatment regimen comprising communicating, with the external neural stimulator, neural stimulation to the subject, the neural stimulation configured to activate at least one sensory nerve fiber that innervates skin on or near an ear of the subject. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In an aspect, a system includes, but is not limited to: circuitry for receiving identification information identifying at least one of a subject and a neurostimulation device associated with the subject, the neurostimulation device configured to be carried on an ear of the subject and comprising an external neurostimulator; and circuitry for providing a recommendation to the subject related to a treatment regimen, the treatment regimen comprising delivering, with the external neural stimulator, neural stimulation to the subject, the neural stimulation configured to activate at least one sensory nerve fiber innervating skin on or near an ear of the subject. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a computer program product includes, but is not limited to: a non-transitory signal bearing medium bearing: one or more instructions for receiving identification information identifying at least one of a subject and a neurostimulation device associated with the subject, the neurostimulation device configured to be carried on an ear of the subject and comprising an external neurostimulator; and one or more instructions for providing a recommendation to the subject regarding a treatment regimen, the treatment regimen comprising delivering, with the external neural stimulator, neural stimulation to the subject, the neural stimulation configured to activate at least one sensory nerve fiber that innervates skin on or near an ear of the subject. In addition to the foregoing, other computer program product aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a nerve stimulating earphone includes an ear canal insert and an outer ear insert. The ear canal insert is adapted to fit into the ear canal of a human subject. The ear canal insert includes at least one first electrode configured to electrically contact skin within the ear canal of the subject. The outer ear insert is adapted to fit within the outer ear of the subject. The outer ear insert comprises: a base configured to fit within a cavity of the outer ear of the subject; a wing configured to fit within a boat of the outer ear of the subject; and at least one second electrode configured to electrically contact at least a portion of the outer ear of the subject. The neurostimulation earpiece further comprises at least one first electrical connector for connecting the at least one first electrode on the ear canal insert to a first current source; and at least one second electrical connector for connecting said at least one second electrode on said outer ear insert to a second current source.

In one aspect, an ear stimulation device controller is disclosed. The ear stimulation device controller comprises: a first analog output connector adapted to connect a first current signal to a first electrode of an ear canal insert of an ear stimulation device; and a second analog output connector adapted to connect a second current signal to a second electrode of an outer ear insert of the ear stimulation device. The ear stimulation device controller further comprises a wireless microcontroller configured to control wireless communication between the ear stimulation device controller and a personal computing device to receive one or more stimulation parameters from the personal computing device; a digital stimulation signal generator configured to generate a digital stimulation signal based at least in part on the one or more stimulation parameters received from the personal computing device; a digital-to-analog converter for converting the digital stimulation signal to an analog voltage waveform; a current driver operably connected to the digital-to-analog converter and adapted to generate a controlled current stimulation waveform in response to the analog voltage waveform; and a power supply operably connected to at least one of the wireless microcontroller, the digital stimulation signal generator, the digital-to-analog converter, and the current driver. The controlled current stimulation waveform is provided to the ear stimulation device via at least the first and second analog output connectors.

In one aspect, a neurostimulation system includes a neurostimulation headset and an ear stimulation device controller operatively coupled to the neurostimulation headset. The nerve stimulating earphone includes an ear canal insert and an outer ear insert. The ear canal insert is adapted to fit into the ear canal of a human subject. The ear canal insert includes at least one first electrode configured to electrically contact skin within the ear canal of the subject. The outer ear insert is adapted to fit within the outer ear of the subject. The outer ear insert comprises: a base configured to fit within a cavity of the outer ear of the subject; a wing configured to fit within a boat of the outer ear of the subject; and at least one second electrode configured to electrically contact at least a portion of the outer ear of the subject. The neurostimulation earpiece further comprises at least one first electrical connector for connecting the at least one first electrode on the ear canal insert to a first current source; and at least one second electrical connector for connecting said at least one second electrode on said outer ear insert to a second current source. The ear stimulation device controller comprises a first analog output connector adapted to connect a first current signal to a first electrode on an ear canal insert of the ear stimulation device; and a second analog output connector adapted to connect a second current signal to a second electrode of an outer ear insert of the ear stimulation device. The ear stimulation device controller further comprises a wireless microcontroller configured to control wireless communication between the ear stimulation device controller and a personal computing device to receive one or more stimulation parameters from the personal computing device; a digital stimulation signal generator configured to generate a digital stimulation signal based at least in part on the one or more stimulation parameters received from the personal computing device; a digital-to-analog converter for converting the digital stimulation signal to an analog voltage waveform; a current driver operably connected to the digital-to-analog converter and adapted to generate a controlled current stimulation waveform in response to the analog voltage waveform; and a power supply operably connected to at least one of the wireless microcontroller, the digital stimulation signal generator, the digital-to-analog converter, and the current driver. The controlled current stimulation waveform is provided to the ear stimulation device via at least the first and second analog output connectors.

In one aspect, a method of controlling an ear stimulation device with a personal computing device includes, but is not limited to: capturing, with an image capture circuit on the personal computing device, an image of a user of the personal computing device through a user-facing camera associated with the personal computing device; processing the image using image processing circuitry on the personal computing device to determine at least one parameter; and controlling, with a neural stimulation control signal determination circuit on the personal computing device, delivery of stimulation with the ear stimulation device to at least one nerve innervating an ear of the user based at least in part on the at least one parameter. In another aspect, the method comprises: processing the image using the image processing circuitry to determine the presence of at least one earpiece of the ear stimulation device positioned at the user's ear; an ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and at least one attribute of the at least one earpiece that represents the usability of the at least one earpiece for one of the left ear or the right ear of the user; determining, using application software on the personal computing device, an ear that can use the headset based on the at least one attribute of the at least one headset; determining, using application software on the personal computing device, whether the ear in which the at least one earpiece is located is the ear in which the earpiece is available; and if the ear in which the at least one earpiece is located is not the ear in which the earpiece is available, sending a control signal from the personal computing device to the ear stimulation device under control of the neurostimulation control signal determination circuitry to prevent delivery of stimulation through the earpiece to the ear in which the earpiece is located. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, an ear stimulation device control system includes, but is not limited to: a personal computing device; a user-facing camera associated with the personal computing device; an image capture circuit adapted to capture an image of a user of the personal computing device from the user-facing camera; an image processing circuit configured to process the image to determine at least one parameter; and a neurostimulation control signal determination circuit configured for controlling delivery of stimulation with an ear stimulation device to at least one nerve innervating an ear of the user based at least in part on the at least one parameter. In another aspect, the image processing circuitry includes a headphone location module configured to process the image to determine the presence of at least one headphone of the ear stimulation device located at an ear of the user; an ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and at least one attribute of the at least one earpiece that represents the usability of the at least one earpiece for one of the left ear or the right ear of the user; and the neurostimulation control signal determination circuitry is configured for determining, based on the at least one attribute of the at least one earpiece, an ear for which the earpiece is available; determining whether the ear in which the at least one earphone is located is the ear in which the earphone can be used; and if the ear in which the at least one earpiece is located is not the ear in which the earpiece is available, sending a control signal from the personal computing device to the ear stimulation device to prevent the stimulus from being delivered to the at least one nerve innervating the ear of the user. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method of controlling an ear stimulation device with a personal computing device includes, but is not limited to: detecting, at an electrical signal input circuit, an electrical signal representative of electrical contact of at least one first electrode with the ear of a user of a personal computing device via at least one first electrode of an earpiece of an ear stimulation device, wherein the at least one ear is operatively connected to the personal computing device, and wherein the ear stimulation device is adapted to stimulate at least one nerve innervating the ear of the user of the personal computing device; determining, using contact determination circuitry on the personal computing device, whether the at least one first electrode is in good electrical contact with the ear of the user; if the at least one first electrode is not in good electrical contact with the ear of the user, sending a control signal from the personal computing device to the ear stimulation device under control of a neurostimulation control signal determination circuit on the personal computing device to prevent delivery of stimulation through the headphones to the ear in which the headphones are located; and communicating a notification to the user regarding the state of the at least one first electrode under control of a notification circuit on the personal computing device. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, an ear stimulation device control system includes, but is not limited to, a personal computing device configured to control delivery to at least one nerve innervating an ear of a user of the personal computing device via an ear stimulation device, the ear stimulation device including at least one first electrode, and the personal computing device including an electrical signal circuit adapted to receive an electrical signal representative of electrical contact of the at least one first electrode with the ear of the user of the personal computing device; a contact determination circuit configured to determine whether the at least one first electrode is in good electrical contact with the ear of the user; a neural stimulation control signal determination circuit configured to send a control signal from the personal computing device to the ear stimulation device to prevent delivery of the stimulation if the at least one first electrode is not in good electrical contact with the ear of the user; and a notification circuit configured to deliver a notification to the user regarding the state of the at least one first electrode. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a personal computing device application for monitoring user usage of a neurostimulation system includes, but is not limited to: an audio delivery module adapted to control delivery of an audio signal from an audio signal source via an audio output of the personal computing device to an audio headset having an ear stimulation device associated therewith, the ear stimulation device configured to stimulate nerves innervating the ear of the user; an emotion assessment module adapted to receive emotion-related input from the user via a first input structure associated with the personal computing device; and evaluating an emotion of the user based at least in part on the emotion-related input; a cofactor input module adapted to receive at least one input related to at least one cofactor related to the user through a second input structure associated with the personal computing device; a user control module adapted to receive at least one user control input through a third input structure of the personal computing device, the user control input for controlling a user-controllable stimulation parameter of the ear stimulation device; a stimulator control module adapted to determine at least one stimulation control parameter based on at least one of the mood of the user, the at least one co-factor, and the at least one user control input; and a controller interface module for communicating the at least one stimulation control parameter to a stimulator controller adapted to control the ear stimulation device in response to the at least one stimulation control parameter. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

In one aspect, a method of controlling an ear stimulation device with a personal computing device includes, but is not limited to: receiving, at the personal computing device, an audio signal from an audio signal source; delivering the audio signal via an audio output of the personal computing device to an audio headset worn by a user, the audio headset having an ear stimulation device associated therewith configured to stimulate nerves innervating the ear of the user; receiving, with an emotion assessment module, an emotion-related input from the user through a first input structure associated with the personal computing device; evaluating, with the emotion assessment module, an emotion of the user based at least in part on the emotion-related input; receiving, with a cofactor input module, at least one input related to at least one cofactor related to the user through a second input structure associated with the personal computing device; receiving, with a user control module, at least one user control input for controlling at least one user-controllable stimulation parameter of the ear stimulation device through a third input structure associated with the personal computing device; determining, with a stimulator control module, at least one stimulation control parameter based on at least one of the mood of the user, the at least one co-factor, and the at least one user control input; and communicating, with a controller interface module, at least one stimulation control parameter to a stimulator controller adapted to control the ear stimulation device in response to the at least one stimulation control parameter. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.

Features from any of the disclosed embodiments may be used in combination with each other, but are not limited to such. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art upon consideration of the following detailed description and the accompanying drawings.

The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

Drawings

Fig. 1 is a diagram of the external anatomy of a human ear.

Fig. 2A is an illustration of a system including a neurostimulation device worn on an ear of a subject.

Fig. 2B is a block diagram of the system of fig. 2A.

Fig. 3 shows a stimulation device comprising a fixation member configured to fit in the outer ear and a clip fixation member.

Fig. 4A depicts a stimulation device including a hook-type securing member.

Fig. 4B depicts the stimulation device of fig. 4A positioned over an ear.

Fig. 5 depicts an embodiment of a stimulation device.

Fig. 6 depicts an embodiment of a stimulation device.

Fig. 7 is a block diagram of a neurostimulation system.

FIG. 8 is a block diagram of a computing system.

Fig. 9 is a flow chart of a method.

Fig. 10 is a block diagram of a neural stimulation device.

FIG. 11 is a flow chart of a method.

Fig. 12 is a block diagram of a neurostimulation system.

FIG. 13 is a block diagram of a system including a personal computing device.

FIG. 14 is a flow chart of a method.

FIG. 15 is a block diagram of a computer program product related to the method of FIG. 14.

FIG. 16 is a block diagram of a system including a personal computing device.

FIG. 17 is a flow chart of a method.

FIG. 18 is a block diagram of a computer program product related to the method of FIG. 17.

FIG. 19 is a block diagram of a system including a personal computing device.

FIG. 20 is a flow chart of a method.

FIG. 21 is a block diagram of a computer program product related to the method of FIG. 20.

FIG. 22 is a block diagram of a system including a personal computing device.

FIG. 23 is a flow chart of a method.

FIG. 24 is a block diagram of a computer program product related to the method of FIG. 23.

Fig. 25 is a block diagram of a system related to the operation of a neurostimulation device.

FIG. 26 depicts data aspects related to FIG. 25.

FIG. 27 is a flow chart diagram of a method.

FIG. 28 is a block diagram of a computer program product related to the method of FIG. 27.

FIG. 29 is an illustration of an embodiment of a system for delivering neural stimulation in conjunction with supplemental stimulation.

Fig. 30A depicts a neurostimulation headset.

Fig. 30B depicts an exploded view of the nerve stimulation earpiece shown in fig. 30A.

Fig. 31 depicts a block diagram of the neurostimulation headset shown in fig. 30A-30B.

Fig. 32A depicts a neurostimulation headset including an exemplary mounting structure and an audio headset.

Fig. 32B depicts the neurostimulation headset shown in fig. 32A.

Fig. 33A depicts a neurostimulation headset including an exemplary mounting structure and an audio headset.

Fig. 33B depicts the exemplary neurostimulation headset shown in fig. 33A.

Fig. 34 depicts a neurostimulation headset including an exemplary mounting structure and an audio headset.

Fig. 35A depicts a neurostimulation headset and an audio headset.

Fig. 35B depicts an exploded view of the nerve stimulation and audio headphones shown in fig. 35A.

Fig. 36 depicts a side view and a top plan view of the outer ear insert shown in fig. 35A-35B.

Fig. 37 depicts side and end views of the ear canal insert shown in fig. 35A-35B.

Fig. 38 depicts a neurostimulation headset.

Fig. 39A depicts an external side view of the neurostimulation headset shown in fig. 38 in an ear of a subject.

FIG. 39B depicts a cross-sectional view of the plane defined by line A-A along FIG. 39A.

Fig. 40 depicts a block diagram of an ear stimulation device controller.

Fig. 41 depicts a block diagram of a printed circuit board of the ear stimulation device controller shown in fig. 40.

Fig. 42 depicts a block diagram of an exemplary neurostimulation system.

FIG. 43 is a flow chart diagram of a method.

FIG. 44 is a flow chart diagram of a method.

FIG. 45 is a flow chart diagram of a method.

FIG. 46 is a flow chart of a method.

Fig. 47 is a block diagram of a neurostimulation system.

Fig. 48A depicts a user interface for a neurostimulation system.

Fig. 48B depicts a user interface for a neurostimulation system.

Fig. 49 is a block diagram of an embodiment of a neurostimulation system.

FIG. 50 is a flow chart diagram of a method.

FIG. 51 is a flow chart diagram of a method.

FIG. 52 is a flow chart diagram of a method.

FIG. 53 is a block diagram of a system including a personal computing device.

FIG. 54 is a flow chart diagram of a method.

FIG. 55 is a flow chart diagram of a method.

FIG. 56 is a flow chart diagram of a method.

FIG. 56 is a flow chart diagram of a method.

FIG. 58 is a flow chart diagram of a method.

FIG. 59 is a flow chart diagram of a method.

FIG. 60 is a flow chart diagram of a method.

Detailed Description

In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like reference numerals generally refer to like elements unless otherwise specified. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.

Various studies have shown that ear stimulation can be beneficial to the health of a subject. For example, Rong et al, "transient variables regulating neural stimulation for the treatment of depression: a study protocol for a double blocked random clinical trial," BMC comparative and Alternative medical 2012,12:255, incorporated herein by reference, describes the possibility of using transauricular stimulation of the vagus nerve through the ear portion to treat Major Depressive Disorder (MDD) and other diseases, including epilepsy, bipolar disorder and morbid obesity. Ellrich "Transcutaneous sources Vagus Nerve Stevaluations," European Neurological Review, 2011; 254 (4) 254-.

Nerves innervating the skin on or near the ear of a subject include, for example, the facial nerve (cranial nerve VII), glossopharyngeal nerve (cranial nerve IX), the auricular branch of the vagus nerve (cranial nerve X), the auriculotemporal branch of the trigeminal nerve (cranial nerve V), the smaller occipital nerve (spinal nerve C3), and the auricular branch of the larger auricular nerve (spinal nerves C2, C3). These nerves contain various nerve fibers including sensory nerve fibers including, for example, nerve fibers from cutaneous mechanoreceptors. Various types of skin mechanoreceptors are well characterized and are innervated by fibers (also known as a β fibers) having diameters in the range of about 5 to 12 μm. Cutaneous mechanoreceptors include, for example, slowly-adapting mechanoreceptors, which are more sensitive to continuous stimuli, and rapidly-adapting mechanoreceptors, which are more sensitive to transient stimuli. For example, rapidly adapting mechanical receptors include pacinian corpuscles (pacinian corpuscles) and Meissner's corpuscles.

Mechanoreceptors are activated well by periodic or vibratory (e.g., sinusoidal) mechanical stimuli with frequencies in the range of 1Hz to 1000 Hz. In some aspects, such mechanical stimulation may include skin indentations of a few microns to a few millimeters. Pacinian corpuscles are considered to be most responsive to vibromechanical stimuli having frequencies in the range of 200Hz to 300Hz, while meissner corpuscles are considered to be most responsive to vibromechanical stimuli having frequencies in the range of 30 to 40 Hz.

Electrical stimulation with a sine wave or other waveform is also effective for activating sensory fibers. For example, the stimulus may be applied periodically. See, e.g., Ellrich, "Transcutaneous sources variable neural Stevaluations," European Neurological Review, 2011; 254 (4) and 256, which are incorporated herein by reference.

For reference, fig. 1 depicts an ear 100 of a human subject, showing anatomical structures that may be referenced herein. The outer portion of the ear 100 is referred to as the pinna 102. Fig. 1 depicts a front/side view of an ear 100, showing a front face 104 of an auricle and a back view of the ear 100, showing a back face 106 of the auricle and a head 108 of a subject. The surface of the head 108 adjacent the pinna 102 is indicated by shading and reference numeral 110. The anatomical features of the ear include the external auditory meatus 112 (external ear canal), helix 114, earlobe 116, and tragus 118. The concha 120, the depressed region near the external ear canal 112, is made up of a cymba (cymba)122 and an ear cavity (cavum)124, and is bounded by an antitragus 126 and an antihelix 128. The antihelix 128 includes a lower (anterior) calf (crus)130 of the antihelix and an upper (posterior) calf 132 of the antihelix that define a triangular fossa 134.

Fig. 2A and 2B show a general system 200 including a wearable neural stimulation device 202 for delivering stimulation to an ear 204 of a subject 206. System 200 includes a personal computing device 208 in communication with wearable neurostimulation device 202 via a communication link 210. The personal computing device 208 may be an audio player, a mobile phone, a computer, or any of a variety of other devices having computing capabilities (e.g., microprocessor-based devices) and including application software and/or appropriate hardware for controlling the operation of the wearable neurostimulation device 202. In an aspect, the personal computing device 208 is a wearable computing device. In one aspect, wearable neural stimulation device 202 is used to deliver stimulation sufficient to activate one or more nerves or nerve branches innervating skin on or near ear 204 of subject 206. In one aspect, the personal computing device 208 is used to control delivery of stimulation to the ear 204 of the subject 206. As shown in the block diagram of fig. 2B and described in more detail below, the wearable neural stimulation device 202 includes a neural stimulator 212 and a securing member 214 for securing the neural stimulator 212 to the ear 204. In an aspect, personal computing device 208 is configured to send or receive information related to the operation of wearable neurostimulation device 202 to or from one or more remote systems 216 via communication network 218. Control of the stimulation may be based on data from one or more sensors 220, including, for example, but not limited to, physiological sensors, neural activity sensors, motion sensors, location sensors, or environmental sensors 220. In some aspects, the sensor 220 is worn by the subject at a location different from the wearable neurostimulation system 202 (e.g., on the armband as shown in fig. 2A). In other aspects, the one or more sensors are located on a wearable neurostimulation device implantable in the subject, on a personal computing device, or elsewhere in the environment of the subject, as shown and described below and in the figures.

In the embodiment of fig. 2A and 2B, and in other embodiments described herein, the neurostimulator 212 may be any of a variety of types of neurostimulators, including, but not limited to: a mechanical stimulator, an electrical stimulator, a magnetic stimulator, an ultrasonic stimulator, an optical stimulator, or a chemical stimulator, as will be discussed in more detail below. In one aspect, a neurostimulation device as described herein may include a plurality (two or more) of neurostimulators (see, e.g., optional additional neurostimulators 222 in fig. 2B). If multiple neurostimulators are used, they may be of the same type, or may be of several different types.

In one aspect, the neural stimulator 212 is a mechanical stimulator. In one aspect, the mechanical stimulator includes, for example, a vibrating mechanical stimulator that delivers periodic or vibrating mechanical stimuli to the skin of the ear of the subject. The vibromechanical stimulator may include various types of vibromechanical devices, such as electromechanical devices, piezoelectric devices, moving coil devices, electrostatic devices, magnetostrictive devices, isodynamic devices, and/or MEMS devices, for example, used to fabricate small speakers and microphones.

In one aspect, the neurostimulator 212 comprises a transcutaneous electrical stimulator for delivering transcutaneous electrical stimulation. For example, the neurostimulator 212 may include electrodes or electrical contacts designed for contacting a skin surface, such as described in "transmissive variables regulating the neural stimulation for the treatment of expression: actual protocol for a double blocked random clinical trial," BMCComplementary and Alternative Medicine 2012,12:255, by Rong et al, which is incorporated herein by reference. In one aspect, the neural stimulator 212 includes a magnetic stimulator for delivering transcutaneous magnetic stimulation. For example, such a magnetic stimulator may include one or more coils through which an electric current is passed to generate a magnetic field. The magnetic field induces an electrical current in the tissue in/around the ear of the subject to activate neural structures. In ONE aspect, neurostimulator 212 comprises an Ultrasound stimulator, such as, for example, described in Legon et al, "Pulsed ultrasonic stimulation stimuli Electrical Circuits in human as Indicated by way of example as EEG and fMRI," PLOS ONE 7(12): e5177.Doi: 10.01371/joural. pane. 0051177, December 2012, which is incorporated herein by reference. In some aspects, other types of neurostimulators are used, such as optical stimulators or chemical stimulators. See, for example, the stimulator described in U.S. patent 8,170,658 to Dacey, Jr.

In some aspects, the circuitry for driving the delivery of neural stimulation is fully or partially included in wearable neural stimulation device 202. In some aspects, some or all of the circuitry for driving the delivery of neural stimulation is housed separately from wearable neural stimulation device 202, and the control signals for driving the delivery of neural stimulation by neural stimulator 212 are provided by personal computing device 208 or from remote system 216 via communication network 218.

Various examples and embodiments of a neurostimulation device are described herein. In various aspects of the neurostimulation systems described herein, the neurostimulation device is wearable, i.e., the apparatus can be carried or worn on the ear of the subject, secured by the securing member, so as to position the neurostimulator(s) relative to a portion of the subject's ear, or in some cases, near the subject's ear. Various types of fixing members may be used without limitation. The securing member may also be used to position one or more sensors on or near the ear of the subject, and may also include or support other system components such as circuit components. Examples of nerve stimulation devices including different types of fixation members are shown in fig. 3-6.

Fig. 3 shows a fixation member 300, which is an concha-fitted member (concha-fitted member) configured to fit into the concha 302 of an ear 304. In this example, the fixation member 300 has a size and shape sufficient to be retained in the outer ear 302 by friction and/or tension of the fixation member 300 relative to the outer ear 302. Other system components may be attached to the fixation member 300, such as an ear canal insert 306 extending into the external ear canal (ear canal) 308, and stimulators 310a, 310b, and 310 c. Furthermore, system components may be built into or contained within the fixation member 300, such as control circuitry and/or communication circuitry (not shown) for driving the stimulators 310a, 310b and 310c and/or providing communication with, for example, a personal computer device (not shown). A battery may be provided in the stationary member 300 to power the device for wireless operation. Fig. 3 also shows a second type of fixation member, i.e., clip 312, for attaching stimulator 314 and/or sensor 316 to pinna 318 of a subject. Circuitry 320 provides wireless communication between stimulator 314/sensor 316 and circuitry on stationary member 300 or a personal computing device or remote system. Spring 322 provides a spring force to secure clip 312 to pinna 318. The clip 312 may be formed from a resilient material or from two rigid material portions that are hingedly connected.

Fig. 4A and 4B illustrate a fixation member 400 having a hook-type configuration designed to be suspended from a pinna 402. The hook-type construction is similar to that used in certain types of headphones for listening to music. The fixing member 400 includes: a front portion 404 which, in use (shown in figure 4B), is located in front of the subject's ear (i.e. in front of the pinna 402); an supra-aural portion 406 that arcs above and behind pinna 402; and a rear portion 408 that fits behind pinna 402. In one aspect, the fixation member 400 includes a downward extension 410. In an aspect, a wired communication link 412 (e.g., a cable) provides a connection between electrical components on the stationary member 400 and a remote computing device. For example, electrodes 414a and 414b on the rear 408 of the fixation member 400 are used to deliver electrical stimulation under the control of control signals delivered via the wired communication link 412. The fixation member 400 further comprises an ear canal insert 416 adapted to fit the external ear canal 112. A sensor 418 on the ear canal insert 416 can be used to sense physiological signals that are used in some aspects to determine the stimulation delivered with the electrodes 414a and 414 b. The physiological sensors 418 may include, for example, electrodes for sensing heart rate or other physiological sensors as described in more detail elsewhere herein. Additional sensors 420 and 422 are located on aspects of the rear portion 408 facing and adapted to contact the surface of the head adjacent the pinna 402. In one aspect, sensors 420 and 422 are electrodes configured to detect electroencephalogram (EEG) signals.

Fig. 5 shows a securing member 500 having a ring-shaped configuration of the type used for wireless headsets. The fixation member 500 includes earplugs 502a and 502b that fit into the left and right ears of the subject, respectively (e.g., into one or both of the outer ear and the outer ear canal). The fixation member 500 also includes arcs 504a and 504b that fit over and behind both ears of the subject, and a connection loop 506 that fits behind the head of the subject and connects the earplugs 502a and 502 b. In one aspect, the securing member 500 is sufficiently rigid to hold the earplugs 502a and 502b in place in the subject's ears while the subject is ambulatory (e.g., walking or running). In one aspect, ear canal inserts 508a and 508b are adapted to fit the ear canal of a subject. The neural stimulator 510 may be positioned on the ear plug 502a as shown, or alternatively (or additionally) on the ear canal extension 508 a. The ancillary neural stimulator 512 may be located on the pinna extension 514. Extension 514 is used to position the ancillary neural stimulator 512 at a desired location on the pinna of the subject. In one aspect, the extension 514 can be adjusted by elastic or plastic deformation to alter the positioning of the neural stimulator 512 on the pinna. In some aspects, extension 514 may include an adjustable connector that provides positioning of neurostimulator 512 relative to the pinna.

Fig. 5 depicts a system in which neurostimulators 510 and 512 are positioned on fixation member 500 in order to deliver stimulation to the left ear of a subject. The neurostimulator may be located on one or both ears of the subject, depending on the desired application. In some aspects, the stimulus is delivered to only one ear, while in other aspects, the stimulus is delivered to both ears.

In some aspects, stimulator 512 located on pinna extension 514 may function as the sole or primary neural stimulator, and stimulator 510 on earplug 502a may be omitted. Independently of carrying the stimulator 510, the earplugs 502a and 502b may be used to hold the fixation member 500 in place relative to the head of the subject and optionally deliver sound (such as a sound signal from a telephone or music from an audio player) to the ears of the subject. The circuitry 516 in the stationary member 506 includes communication circuitry for wirelessly communicating with other system components, such as a personal computing device (e.g., an audio player, a mobile phone, or a laptop computer). Further, the circuitry 516 may provide wireless communication with a sensor located a distance from the stationary member 500. For example, the wireless headset device shown in fig. 5 may be used in combination with sensors in one or more locations (not limited to sensors on the stationary member 500). The sensors include any type of physiological sensor located within, on, or near the body of the subject (e.g., implanted sensors, sensors secured to the body, sensors in an article of wear (such as clothing, wrist band, etc.)); remote sensors, environmental sensors, motion sensors, position sensors, and/or other types of sensors, but is not limited to such.

Fig. 6 shows another example of a wearable neurostimulation device 600, which includes a housing 602 attached to a fixation member 604. The housing 602 is shown only in dashed outline so that the position of the stimulator 606 and sensor 608 can be seen relative to the ear 610. The housing 602 is a thin, flat box-like structure with the stimulator 606 and sensor 608 mounted on the exterior of the housing 602, on the side facing the pinna 612. The housing 602 is secured to the stationary member 604 or integrally formed with the stationary member 604. The fixation member 604 fits into the outer ear 614 to secure the device 600 to the ear 610. The ear canal insert 616 fits into the external ear canal 618. A sensor 620 on the ear canal insert 616 senses physiological signals from the external ear canal 618. Sensor 608 is an environmental sensor that senses light from the environment of the subject, e.g., to determine whether it is day or night.

Fig. 7 is a block diagram of a neurostimulation system 700. The neural stimulation system 700 includes a neural signal sensor 702 adapted to sense a neural signal 704 from a subject. The neural signal 704 may be an electroencephalogram (EEG) signal or an Electrooculogram (EOG) signal, and in an aspect is indicative of a physiological state of the subject. The neurostimulation system 700 further includes a neurostimulator 706 adapted for generating a stimulus 708 in response to the sensed neural signal 704, the stimulus 708 configured for activating at least one sensory nerve fiber innervating at least a portion of a pinna of the subject. The neurostimulation system 700 also includes a fixation member 710 configured for fixing the neurostimulator 706 to a pinna of a subject.

In various aspects, the neural signal sensor 702 may be an electroencephalogram signal sensor 712 or an electrooculogram signal sensor 714. The electroencephalogram signal sensor 712 can be configured to fit within the ear canal of a subject, for example, on an ear canal insert as shown in fig. 4A (e.g., as described in U.S. patent publication 2003/0195588 to fisherll et al or U.S. patent publication 2006/0094974 to Cain, both of which are incorporated herein by reference). The EOG sensor 714 may be located on an extension (e.g., similar to the extension 514 shown in fig. 5) to position the EOG sensor 714 on the temple of the subject or on a side of the head of the subject. Electromyogram signal sensors may be similarly placed. The physiological state of the subject as indicated by the neural signal 704 may include indications or symptoms of various types of physiological states, including various brain-related diseases or states or other physiological states. Brain related disorders include, for example, mental health disorders (e.g., psychological or psychiatric disorders), depression, post-traumatic stress disorder, seasonal affective disorder, anxiety, headache (e.g., primary headache, cluster headache, or migraine), or epilepsy). The neural signal sensor 704 may include other types of neural signal sensors, including external sensors or implantable sensors located in or on the ear or other part of the body. One or more neural signal sensors may be used.

In various aspects, fixation member 710 is configured to secure neurostimulator 706 to different portions of a subject's pinna. For example, in one aspect, the fixation member 710 includes an outer ear adaptation portion 716 configured to fit over the outer ear of the subject (e.g., as shown in fig. 3). In one aspect, the securing member 710 includes an ear canal insert 718, the ear canal insert 718 configured to fit into the ear canal of a subject (e.g., as shown in fig. 4A, 4B, and 5). In another aspect, the securing member 710 is a hook-type securing member 720 as shown in fig. 4A and 4B. The neurostimulator may be secured to the back of the pinna, or to the surface of the head adjacent to the pinna, using a hook-type securing member 720. In another aspect, the fixation member 710 is an annular fixation member 722 (e.g., of the type shown in fig. 5). In another aspect, the securing member 710 includes a clip 724 (e.g., of the type shown in fig. 3). Clips may be used to secure neurostimulator 706 to various portions of the anterior or posterior of the pinna, including the anterior or posterior portions of the earlobe. In another aspect, the securing member 720 includes an extension 726 (e.g., extension 514 as shown in fig. 5). Such extensions can be used to position the neurostimulator in almost any desired location on the pinna, or on the head, adjacent to and above, below, in front of, or behind the ear. In one aspect, the fixation member 710 includes a housing 728. It should be noted that the housing 710 may in some cases serve as an extension. For example, the housing 602 shown in fig. 6 also serves as an extension from the fixation member 604 to provide for placement and fixation of the stimulator 606 and sensor 608 on a portion of the pinna 612 that is not immediately adjacent to the fixation member 604. The fixation member 710 may be configured to fix the neurostimulator to the subject's outer ear, tragus, front or back of the pinna, helix, or various other portions of the pinna (e.g., the fossa trigone, antihelix, upper or lower leg of antihelix, antitragus, or tragus). In some aspects, the fixation member 710 is permanently configured to position the neurostimulator 706 at a particular location relative to the ear of the subject, wherein in some aspects, the fixation member 710 is adjustable such that the positioning of the neurostimulator 706 can be selected by the subject. For example, the sensor or stimulator may be secured to a particular portion of the pinna by being pressed against the pinna by a securing member or extension sufficiently tightly to make reliable mechanical or electrical contact with the pinna. In one aspect, the fixation member 710 comprises a shape memory material. Various materials may be suitable for the construction of the fixation member 710, including, but not limited to: hard or soft, elastic or plastic deformable polymers, metals, ceramics, glass, and composites formed therefrom. Flexible or stretchable electronic circuits formed from flexible materials or structures (e.g., conductors having, for example, serpentine designs) or elastic conductive materials (e.g., conductive polymers) may be used for the sensors and stimulators that conform to the pinna. While the discussion herein focuses on positioning the neurostimulator with the fixation member 710, it should be understood that the fixation member 710 may also be configured to position the transducer relative to the ear in a similar manner. Several such examples are provided in fig. 3-6.

In one aspect, the neural stimulator 706 is positioned relative to the fixation member 710 such that when the fixation member 710 is worn on the pinna, the neural stimulator 706 is positioned (fixed) on a particular region of the pinna, for example, on a region of the pinna innervated by a cranial nerve (e.g., the vagus, facial, trigeminal, or glossopharyngeal nerves). Such a location may be selected based on knowledge of innervation of the pinna, for example, as provided in references such as Cranial Nerves in health and Disease, by Linda Wilson-Pauwels, Elizabeth J.Akesson, Patricia.Stewart, and mean D.Spacey; BC Decker inc; 2edition (January 1,2002); ISBN-10:1550091646/ISBN-13:978-1550091649, which is incorporated herein by reference.

As described above, neurostimulator 706 may be, for example, a mechanical stimulator 730 (e.g., a vibrating mechanical stimulator 732), a transcutaneous electrical stimulator 734, a transcutaneous magnetic stimulator 736, an ultrasound stimulator 738, a chemical stimulator 740, a thermal stimulator 742, or other types of stimulators.

As shown in fig. 7, in one aspect, the neurostimulation system 700 includes at least one auxiliary sensor 750. In an aspect, the neural signal sensor 702 is a primary neural signal sensor and the secondary sensor 750 is a secondary neural signal sensor 752, the secondary neural signal sensor 752 may be, for example, an electroencephalogram (EEG) sensor 754 or an Electrooculogram (EOG) sensor 756. Secondary neural signal sensor 752 may be of the same or different type as primary neural signal sensor 702 and may be located at the same or different location on the body as primary neural signal sensor 702. In one aspect, the auxiliary sensor 750 is a physiological sensor 758, such as an Electromyography (EMG) sensor 755, a heart rate sensor 760 (which may be used for heart rate variability as well as heart rate, and may include, but is not limited to, an EKG or pulse oximeter based heart rate sensor), a blood pressure sensor 762, a sweat sensor 764, a skin conductivity sensor 766, a respiration sensor 768, a pupil dilation sensor 770, a digestive tract activity sensor 772, or a pilatory sensor 774. In another aspect, auxiliary sensor 750 is an environmental sensor, such as light sensor 782, which may be configured to sense light level 784 or day length 786. The environmental sensor 750 may include a temperature sensor 788 or an acoustic sensor 790 configured to sense an ambient noise level 792, for example. Other types of sensors for providing information about the subject's state and his or her environment may be used, including but not limited to, for example, a motion sensor 794 or a position sensor 796. Various physiological and environmental sensors are described in U.S. patent 8,204,786 to lebouuf et al, which is incorporated herein by reference. Digestive tract activity may be sensed with an external acoustic sensor, for example as described in "New dispassable biosensor mass help strategies can safe be fed following delivery supply," medical Xpress, August 7,2014, which is incorporated herein by reference.

In one aspect, the neurostimulation system 700 includes an auxiliary signal input 800. In various aspects, the signal received at the auxiliary signal input 800 includes: a signal from the delivery apparatus 802 (indicative of delivery of a medication or healthcare medication to the subject), an input to the game 804 (e.g., a signal corresponding to a subject input to a video game played by the subject), an output from the game 806 (e.g., a signal output by the game system indicative of a state or event of a video game played by the subject), a user input to the virtual reality system 808, an output from the virtual reality system 810 (e.g., a signal output by the VR system indicative of a state or event of the VR system), a user input device 812 (e.g., a user input device of a computing device or a user input to a neurostimulation system), or a computing device input 814 (e.g., a data input). The input received through the user input device or computing device input may be indicative of, for example, ingestion of food, beverages, nutrition, or pharmaceuticals by the subject. The input received through the user input device may be provided by the subject or other user (e.g., a healthcare worker). The input may be provided autonomously by the user or in response to a prompt or query. In an aspect, the input may be provided by the user in response to a query or prompt that constitutes a portion of a quiz, questionnaire, or survey (including, for example, questions presented in a "yes/no" or "multiple choice" reply format). The user responses provided in response to these prompts or queries may be indicative of the psychological or emotional state of the subject. The input received through the data input may include, for example, health-related information of the subject, including genomic or microbiome information of the subject, information from a medical record of the subject, or other information related to the health of the subject.

In one aspect, the neurostimulation system 700 includes a clock or timer 816. In various aspects, the neurostimulator 706 is adapted to generate the stimulation 708 based at least in part on the time indicated by the clock/timer 816 and/or based at least in part on the date indicated by the clock/timer 816.

Data extracted from one or more neural signals, physiological signals, environmental signals, or other ancillary signals or ancillary inputs (e.g., ancillary signal input 800 in fig. 7) and clock or timer information (e.g., obtained with ancillary sensor 750 in fig. 7) may be associated with a psychological or emotional state of the subject, reported to a healthcare provider or other party, and/or stored in a medical or health record of the subject. In particular, the value of any such parameter indicative of a deterioration in the mental or physical/physiological state of the subject may be reported to a healthcare provider so that appropriate intervention may be made and/or used as a basis for modulating the delivery of neural stimulation.

In various aspects, neurostimulation system 700 includes at least one auxiliary stimulator 818 for delivering auxiliary stimulus 820 to a subject. In one aspect, auxiliary stimulator 818 is an auxiliary neurostimulator 822, which may be any of the various neurostimulators described in association with neurostimulator 706, and which may be of the same or different type as neurostimulator 706. Alternatively, the auxiliary stimulators 818 may include, for example, mechanical stimulators 824, audio players 826, auditory stimulation sources 828, virtual reality systems 830, augmented reality systems 832, visual stimulation sources 834, tactile (tactile) stimulators 836, tactile (tactile) stimulators 838, scent sources 840, virtual therapists, or delivery devices 844 for delivering drugs or nutrients.

In various aspects, the neurostimulation system 700 includes a control circuit 846 carried by the fixation member 710 (either directly on the fixation member 710 or on an extension or housing connected to the fixation member 710, e.g., as shown in fig. 3-6), the control circuit 846 configured to control the neurostimulator 706.

In an aspect, the neurostimulation system 700 comprises a communication circuit 848, the communication circuit 848 carried by the fixation member 710 and configured for at least one of: one or more signals 850 are transmitted to the personal computing device 852 and one or more signals 854 are received from the personal computing device 852.

In one aspect, the neurostimulation system 700 comprises an acoustic source 856 for delivering an auditory signal to the subject. The sound source 856 may be, for example, a speaker 858. The acoustic source 856 can be configured (e.g., using suitable electronic circuitry, not shown) to communicate instructions 860 or an alert 862 to the subject.

In one aspect, the neurostimulation system 700 includes a position sensor 864 for sensing the position of the neurostimulator 706 relative to the pinna of the subject. The position sensor 864 can detect the position of the neurostimulator 706 relative to the pinna by: detecting electrical activity from a nerve; detecting an image of the ear and determining a location based on a landmark in the image; or to detect temperature, pressure, or a capacitive signal indicative of sufficient contact of the stimulator with the ear.

In one aspect, the neurostimulation system 700 includes a connector 866 for connecting the neurostimulator to a personal computing device. Connector 866 includes, for example, a receptacle or port for establishing a wired (cable) connection with a personal computing device. In one aspect, the neurostimulation system 700 includes a user interface 867 for receiving input from a subject or presenting information to a subject. In one aspect, the user interface 867 includes a small display, one or more indicator lights, and simple user inputs, such as one or more buttons or dials for adjusting device settings and viewing and modifying system settings.

Fig. 8 shows a general form of a circuit-based system as described in fig. 7 and elsewhere herein. While specific embodiments are described herein, it will be appreciated by those of ordinary skill in the art that the methods and systems described herein may be implemented in various ways. Reference is made herein to various circuitry and subsystems (e.g., neurostimulation system 700 includes control/processing circuitry 846 in fig. 7, which may be considered control/processing circuitry, as shown generally in fig. 8, system 870 includes circuitry-based system 872. in some aspects, circuitry-based system 872 is a computing device or computing subsystem, including control/processing circuitry 874, which includes digital and/or analog components 876, one or more processors 878 (e.g., microprocessors), and any or all of memory 880 that may store one or more program modules 882 and/or data 884. in some aspects, the control/processing circuitry provides for preliminary processing of data from one or more sensors 886, communication of data to a remote device 896, receipt of control signals from a remote device 896, and actuation of actuator 888, the actuator 888 may be, for example, a neural stimulator (such as the neural stimulator 706 shown in fig. 7). Signals from various sensors (e.g., sensor 886 shown in fig. 8) may be received as described herein. The system 870 may include other components known to those skilled in the art such as one or more power supplies 890, I/O structures 892, clocks, timers, data buses, etc. The I/O structures 892 allow communication with various types of user interface devices (represented by the user interface 894, which may include one or more input devices such as a keyboard, buttons, switches, a computer mouse or touch screen, or one or more output devices such as a screen, sound source, alphanumeric display, braille display, etc.) and with various types of remote devices 896 (e.g., the remote system 216 in fig. 2A-2B), which remote devices 896 may have control/processing capabilities imparted by the control/processing circuitry 898.

In a general sense, the various embodiments described herein may be implemented individually and/or collectively by various types of circuitry having a wide range of electrical components (e.g., hardware, software, firmware), and/or virtually any combination thereof. The circuitry (including, for example, control/processing circuitry 846 in fig. 7) includes: circuitry having at least one discrete circuit, circuitry having at least one integrated circuit, circuitry having at least one application specific integrated circuit, circuitry forming a computing device configured by a computer program (e.g., a computer configured by a computer program that at least partially executes processes and/or devices described herein, or a microprocessor configured by a computer program that at least partially executes processes and/or devices described herein), electronic circuitry forming the memory device (which may include various types of memory (e.g., random access, flash, read-only, etc.)), circuitry forming a communication device (e.g., communication circuit 848 in fig. 7) (e.g., a modem, a communication switch, an optoelectronic device, etc.), and/or any non-electrical analog thereof, such as optical or other analogs (e.g., graphene-based circuits). In one embodiment, the system is integrated such that the system operates as a unique system specifically configured for the function of the neurostimulation system described herein. In one embodiment, one or more associated computing devices of the system operate as a special-use computer for the purposes of the claimed system, rather than as a general-use computer. In one embodiment, one or more of the associated computing devices of the system are hardwired with a particular ROM to indicate the one or more computing devices.

In a general sense, the various aspects described herein, which may be implemented individually and/or collectively by a wide range of hardware, software, firmware, and/or any combination thereof, may be viewed as being comprised of various types of "electrical circuitry".

At least a portion of the devices and/or processes described herein may be integrated into a data processing system. Data processing systems typically include one or more of the following: a system unit housing; a video display; memory such as volatile or non-volatile memory; a processor such as a microprocessor or digital signal processor; computing entities such as operating systems, drivers, graphical user interfaces, and applications; one or more interactive devices (e.g., a touchpad, a touchscreen, an antenna, etc.); and/or a control system including a feedback loop and a control motor (e.g., a control motor for sensing position and/or velocity; for moving and/or adjusting a component and/or quantity). The data processing system may be implemented using suitable commercially available components such as those typically found in data computing/communication and/or network computing/communication systems.

In various embodiments, the methods described herein may be performed according to instructions that can be implemented in hardware, software, and/or firmware. Such instructions may be stored, for example, in a non-transitory machine-readable data storage medium. The prior art has evolved to the point where there is little difference between hardware, software, and/or firmware implementations of various aspects of the system; the use of hardware, software, and/or firmware is generally (but not always, in that the choice between hardware and software may become important in some contexts) a design choice representing a cost versus efficiency tradeoff. There are a variety of vehicles by which processes and/or systems and/or other technologies described herein can be effected (e.g., hardware, software, and/or firmware), and the preferred vehicle will vary with the environment in which the processes and/or systems and/or other technologies are deployed. For example, if the implementer determines that speed and accuracy are superior, the implementer may opt for a mainly hardware and/or firmware vehicle; alternatively, if flexibility is superior, the implementer may choose the primary software implementation; or again, alternatively, the implementer may opt for some combination of hardware, software, and/or firmware in one or more machines, components of matter, and articles of manufacture. Thus, there are several possible vehicles by which the processes and/or devices and/or other techniques described herein can be effected, none of which is inherently superior to the other in that any vehicle to be utilized is a choice dependent upon the environment in which the vehicle will be deployed and the particular considerations of the implementer (e.g., speed, flexibility, or predictability), any of which may vary. The optical aspects of the implementations will typically be implemented in optically-oriented hardware, software, and/or firmware.

In some implementations described herein, logic and similar implementations may include computer programs or other control structures. For example, an electronic circuit may have one or more current paths constructed and arranged to implement the various functions described herein. In some implementations, one or more media may be configured to carry an apparatus-detectable implementation when such media holds or transmits device-detectable instructions operable to be executed in a manner described herein. In some variations, for example, implementation may include updating or modifying existing software or firmware or gate arrays or programmable hardware by, for example, executing the reception or transmission of one or more instructions related to one or more operations described herein. Alternatively or additionally, in some variations, implementations may also include dedicated hardware, software, firmware components, and/or general components that execute or invoke the dedicated components.

Implementations may include dedicated instruction sequences or call circuits for enabling, triggering, coordinating, requesting, or otherwise causing one or more of virtually any of the functional operations described herein. In some variations, the operations or other logical descriptions herein may be represented as source code and compiled or otherwise invoked as a sequence of executable instructions. In some cases, for example, implementations may be provided in whole or in part by source code (e.g., C + + or other code sequences). In other implementations, a source or other code implementation using commercially available and/or state of the art techniques may be compiled/implemented/translated/converted into a high level description language (e.g., techniques described initially in the C or C + + programming language, after which the programming language implementation is converted into a logically synthesizable language implementation, a hardware description language implementation, a hardware design simulation implementation, and/or other similar representations). For example, some or all of the logical expressions (e.g., computer programming language implementations) may be represented as Verilog-like hardware descriptions (e.g., in Hardware Description Language (HDL) and/or very high speed integrated circuit hardware description language (VHDL)) or other circuit models, which may then be used to build a physical implementation with hardware (e.g., an application specific integrated circuit).

The detailed description sets forth various embodiments of the devices and/or processes via the use of block diagrams, flowcharts, and/or examples. To the extent that such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, each function and/or operation in such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. In an embodiment, portions of the subject matter described herein may be implemented by an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), a Digital Signal Processor (DSP), or other integrated form. However, some aspects (in whole or in part) of the embodiments disclosed herein may be implemented efficiently in an integrated circuit as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and designing the circuit or writing the code for the software and/or firmware would be well within the skill of one of skill in the art in light of this disclosure. Moreover, the mechanisms of the subject matter described herein are capable of being distributed as a program product in a variety of forms, and the illustrative embodiments in which the subject matter described herein applies are not limited to the particular type of signal bearing media used to actually carry out the distribution. Examples of signal bearing media include, but are not limited to, non-transitory machine-readable data storage media, e.g., recordable type media such as floppy disks, hard disk drives, Compact Disks (CDs), Digital Video Disks (DVDs), digital tapes, computer memories, and the like. A signal bearing medium may also include transmission type media such as digital or analog communication media (e.g., fiber optic cables, waveguides, wired communications links, wireless communication links (e.g., transmitter, receiver, transmit logic, receive logic, etc.).

Fig. 9 is a flow chart of a method 900 related to use of the neurostimulation system shown in fig. 7. Here and elsewhere, the method steps outlined by dashed lines are meant to be included in some, but not all, method aspects, and combinations of steps other than those specifically depicted in the figures are possible, as would be understood by one of ordinary skill in the relevant art. The method 900 includes: sensing a neural signal indicative of a physiological state of a subject with a neural signal sensor, the neural signal sensor being located in or on a portion of a body of the subject, as shown at 902; determining at least one parameter of the sensed neural signal with a signal analysis circuit, as shown at 904; and delivering neural stimulation in response to the sensed neural signals with a neural stimulation device worn on a pinna of the subject, wherein the neural stimulation is configured to modulate activity of at least one sensory nerve fiber innervating at least a portion of the pinna of the subject, as shown at 906. In one aspect, the neural stimulation is of sufficient frequency and amplitude to modulate the activity of at least one sensory nerve fiber innervating at least a portion of a pinna of the subject. For example, in various aspects, the neural stimulation has a frequency within a suitable range of 1Hz-1000Hz, 10Hz-500Hz, 30Hz-40Hz, 10Hz-50Hz, 10Hz-80Hz, 50Hz-100Hz, or 200-300 Hz. In one aspect, the stimulus has a sinusoidal waveform. In other aspects, the stimulus may have a triangular, rectangular, square, trapezoidal, or other waveform delivered periodically with a cycle frequency within the ranges listed above. It should be understood that a given stimulus may include higher or lower frequencies depending on the stimulus waveform or pulse shape or envelope shape. The neural stimulation may be delivered according to a programmed pattern, which may be stored in memory on the neural stimulation device or on a personal computing device or other remote device in communication with the neural stimulation device. In various aspects, the neural stimulation is delivered continuously, intermittently, and/or in a time-varying manner. The neural stimulation may be pulsed stimulation.

In one aspect, the neural stimulation is delivered using a neural stimulation device, and/or the neural stimulation is configured to activate a cranial nerve (e.g., the vagus, facial, trigeminal, or glossopharyngeal nerves). The nerve stimulation device may be configured to stimulate a particular nerve by one or both of: the method includes positioning a neurostimulator over at least a portion of an receptive region of a nerve of interest, and selecting an amplitude and other stimulation parameters (e.g., frequency, waveform, duration) of stimulation delivered to activate nerve fibers in the nerve of interest.

In one aspect, the method includes delivering neural stimulation in response to at least one parameter of the sensed neural signal. The at least one parameter may include, for example, a frequency content of the electroencephalogram signal, an amplitude of the electroencephalogram signal, a rate of eye movement determined from the electrooculogram, or a gaze direction determined from the electrooculogram. In some aspects, the parameters are indicative of a brain-related disorder or a symptom thereof. In one aspect, method 900 includes delivering neural stimulation in response to detection of a brain-related condition (e.g., which may be any mental health disorder (e.g., a psychological or psychiatric disorder), depression, post-traumatic stress disorder, seasonal affective disorder, anxiety, headache (e.g., primary headache, cluster headache, or migraine), or epilepsy). In one aspect, the method includes delivering the neural stimulation until symptoms of the brain-related disorder are no longer detected.

In an aspect, method 900 includes sensing at least one auxiliary signal with an auxiliary sensor. In an aspect, delivery of the neural stimulation may be started, stopped, or modulated in response to the ancillary signal. The secondary signal may be a secondary neural signal (of the same or different type and sensed from the same or different location as compared to the primary neural signal), or may be, for example, another type of physiological signal, an environmental signal, a location signal, or a signal from a motion sensor. Such an ancillary signal may provide additional information related to determining whether to apply the neural stimulation, evaluating the subject's response to the neural stimulation, identifying an appropriate time for delivery of the neural stimulation, and so forth. The auxiliary signal may comprise other types of auxiliary signals, for example, an auxiliary signal as received by auxiliary signal input 800 in fig. 7. In one aspect, method 900 includes delivering at least one auxiliary stimulus to the subject in addition to delivering the neural stimulus with the neural stimulation device. The auxiliary stimulus may be any of various types of auxiliary stimulus, such as an auxiliary stimulus delivered using auxiliary stimulator 818 as described in fig. 7. In various aspects, method 900 includes controlling the neurostimulation device with control circuitry located at least partially on the neurostimulation device or at least partially on a personal computing device in communication with the neurostimulation device worn on the pinna of the subject. In one aspect, method 900 includes sending signals to or receiving signals from a personal computing device from a neurostimulation device worn on a pinna of a subject. In one aspect, method 900 includes delivering an auditory instruction or auditory alert to a subject using an acoustic source operatively connected to a neurostimulation device. In one aspect, method 900 includes sensing a position of the neurostimulation device relative to a pinna of the subject with a position sensor operatively connected to the neurostimulation device. If the neurostimulation device is not properly positioned, an auditory instruction or alarm may remind the subject to correct the positioning of the neurostimulation device. Alternatively or additionally, the visual alert may be provided to the subject in the form of one or more flashing lights, graphics, or text messages conveyed via LEDs or other light emitting elements, alphanumeric displays, screens, or other display elements on the neurostimulation device or on the personal computing device.

Fig. 10 depicts an embodiment of a wearable neurostimulation device 1000 that includes a vibrating mechanical stimulator 1002. The vibromechanical stimulator 1002 is adapted to generate vibrational stimulation having a sufficient frequency and amplitude to modulate the activity of at least one mechanoreceptor having a receptive field on at least a portion of a pinna of a subject and a fixation member 710 configured to secure the vibromechanical stimulator 1000 to the pinna. The securing member 710 is as described above. The vibrating mechanical stimulator 1002 is a vibrating stimulator, such as the vibrating stimulator 732 generally described in connection with fig. 7. In various aspects, the vibromechanical stimulator 1002 includes an electromechanical device 1004, a piezoelectric device 1006, a moving coil 1008, an electrostatic device 1010, a magnetostrictive device 1012, a motive device 1014, a MEMS device 1016, and/or stretchable electronics 1018.

In one aspect, the neurostimulation device 1000 comprises at least one sensor 1020, and the sensor 1020 can be any of the various types of sensors described in conjunction with the auxiliary sensor 750 in fig. 7, such as a physiological sensor 758, a neural signal sensor 752, an environmental sensor 780, a motion sensor 794, or a position sensor 796. In various aspects, the neurostimulation device 1000 comprises an auxiliary signal input 800, an auxiliary stimulator 818, a control circuit 846 carried by the fixation member 710, a communication circuit 848, an acoustic source 856, a position sensor 864, and a connector 866, all of which have been discussed in connection with fig. 7.

Fig. 11 is a flow chart of a method 1100 related to use of the neurostimulation system shown in fig. 10. In one aspect, method 1100 includes delivering vibromechanical stimulation to at least a portion of a pinna of a subject with a neural stimulation device worn on the pinna of the subject, wherein the vibromechanical stimulation has a frequency and amplitude sufficient to modulate activity of at least one mechanoreceptor having a receptive field on at least a portion of the pinna, as indicated at 1102. In one aspect, method 1100 includes delivering vibromechanical stimulation within a sufficient spatial extent of a pinna to modulate the activity of at least one mechanoreceptor, as shown at 1104.

In one aspect, the vibromechanical stimulation has a waveform sufficient to modulate the activity of at least one mechanoreceptor having a receptive field over at least a portion of a pinna. For example, the vibromechanical stimulus may have a sine wave or other waveform. In some aspects, delivering the vibromechanical stimulation according to a programmed pattern may include delivering the vibromechanical stimulation continuously or intermittently.

In one aspect, as shown at 1106, method 1100 includes sensing a signal with a sensor and controlling delivery of vibromechanical stimulation based at least in part on the sensed signal. The sensed signal may utilize any of various types of signals sensed by sensor 1018 in fig. 10. In various aspects, controlling the delivery of the vibromechanical stimulation based at least in part on the sensed signal includes adjusting the delivery of the neural stimulation in response to the sensed signal or delivering the vibromechanical stimulation in response to the sensed signal. In an aspect, controlling delivery of the vibromechanical stimulation based at least in part on the sensed signal includes initiating delivery of the vibromechanical stimulation in response to the sensed signal.

In an aspect, method 1100 includes receiving a signal from an input and controlling delivery of vibromechanical stimulation based at least in part on the received signal, as shown at 1108. The received signal may be any of various types of input signals received, for example, at auxiliary signal input 800 in fig. 10.

In an aspect, method 1100 includes sensing at least one second sensing signal with a second sensor and controlling delivery of the vibromechanical stimulation based at least in part on the second sensing signal, as shown at 1110.

In one aspect, method 1100 further includes delivering auxiliary stimulation to the subject, as shown at 1112, which may include delivering auxiliary stimulation using auxiliary stimulator 818, as described in connection with fig. 7.

As discussed with respect to method 900, the vibromechanical stimulation may be delivered in response to detection of a symptom of a brain-related disorder, which may include, for example, mental health disorders, depression, post-traumatic stress disorder, seasonal affective disorder, anxiety, headache, or epilepsy. In one aspect, method 1100 includes delivering the vibromechanical stimulation until symptoms of the brain-related disorder are no longer detected.

Fig. 12 depicts a neurostimulation system 1200, which includes a wearable neurostimulation device 1202 and a personal computing device 1204. The personal computing device 1204 may be packaged separately from the wearable neural stimulation device 1202, e.g., similar to the systems shown in fig. 2A and 2B. Wearable neural stimulation device 1202 includes: a neurostimulator 706 adapted for generating stimulation for activating at least one sensory nerve fiber innervating at least a portion of a pinna of a subject; a fixing member 710 configured to fix the nerve stimulator to an auricle; a control circuit 1206 for controlling operation of the neurostimulator 706; and a first communication circuit 1208. The neurostimulator 706 and the fixation member 710 are as described above in connection with fig. 7. Both the control circuit 1206 and the first communication circuit 1208 are incorporated into the wearable neuron stimulation device 1202. The first communication circuit 1208 is operatively connected to the control circuit 1206 and is configured for at least one of: signals 1210 are sent to personal computing device 1204 and signals 1212 are received from personal computing device 1204. Other system components that may be included in the wearable neural stimulation device 1202 or used in conjunction with the wearable neural stimulation device 1202 include: auxiliary signal input 800, auxiliary stimulator 818, acoustic source 856, position sensor 864, and connector 866 as described above in connection with fig. 7, and sensor 1018 as described above in connection with fig. 10. In one aspect, neurostimulation system 1200 includes a user interface 1221, user interface 1221 including a user input device 1222 for receiving input from a subject or other user, and a user output device 1223. The user input device 1222 may be any of various types of user input devices known to those of ordinary skill in the art, including but not limited to buttons, keyboards, keypads, touch screens, voice inputs, and the like. In system 1200 and other neurostimulation systems described herein, system components such as secondary signal input 800, secondary stimulator 818, sound source 856, location sensor 864, connector 866, sensor 1018, and user input device 1221 may, in some cases, be built into a wearable neurostimulation device (e.g., wearable neurostimulation device 1202), and in some cases the wearable neurostimulation device is packaged separately but used in combination with the wearable neurostimulation device. For example, the sensor may be located on the body of the subject, at a location other than the ear, or near the subject and not on the body of the subject. In some cases, the sensor may be implanted within the body of the subject. Similarly, one or both of the secondary stimulator and the acoustic source may be located on the wearable neurostimulation device, on a different body of the subject than the neurostimulation device, or located near the subject and not on the subject's body.

The personal computing device 1202 includes: a user interface 1214 for at least one of presenting information to and receiving information from a user, control circuitry 1216 operatively connected to the user interface 1214, and second communication circuitry 1218 configured to send signals to at least one of the first communication circuitry 1208 carried by a housing of the wearable neurostimulation device and receive signals from the first communication circuitry 1208. Further, the personal computing device 1202 includes instructions 1220 that, when executed on the personal computing device 1204, cause the personal computing device 1204 to perform, via the second communication circuitry 1218, at least one of: send signals 1212 to the wearable neural stimulation device 1202 and receive signals 1210 from the wearable neural stimulation device 1202.

Communication circuitry 1208 and 1218 provide communication between wearable neural stimulation device 1202 and personal computing device 1204. Further, in some aspects, one or both of the communication circuitry 1208 and 1218 provide for communication of the wearable nerve stimulation device 1202 or the individual's communication computing device 1204 with a remote system 1224, respectively. In some aspects, communication circuitry 1208 and 1218 provide wired communication between the wearable neurostimulation device and the personal computing device 1204. Wired communication with the wearable neurostimulation device can occur via connector 866. Alternatively or additionally, a wireless communication link is established between the wearable neural stimulation device 1202 and the personal computing device 1204 and/or between the wearable neural stimulation device 1202 or the personal computing device 1204 and the remote system 1224. In various aspects, the wireless communication link comprises radio frequency, wireless network, cellular network, satellite, WiFi, BluetoothAt least one of a wide area network, a local area network, or a body area network communication link. Various types of communication links are suitable for providing communication between two remote locations. Communications between locations remote from each other may be conducted over a telecommunications network, such as a public or private Wide Area Network (WAN). In general, communication between remote locations is not considered suitable for communication by technologies directed to physically localized networks (e.g., Local Area Network (LAN) technologies at layer 1/2 (e.g., ethernet)In the form of a mesh or WiFi)). However, it should be understood that portions (but not the entirety) of the communication network used in telecommunications may include technologies suitable for physically localizing networks, such as ethernet or WiFi.

In one aspect, the personal computing device 1204 is a personal digital assistant 1226, a personal entertainment device 1228, a mobile phone 1230, a laptop computer 1232, a tablet personal computer 1234, a wearable computing device 1236 (e.g., a fitness band, clothing, or glasses with computing capabilities), a networked computer 1238, a computing system 1240 that includes a cluster of processors, a computing system 1242 that includes a cluster of servers, a workstation computer 1244, and/or a desktop computer 1246. In various aspects, the personal computing device 1204 includes, for example, one or more of a portable computing device, a wearable computing device, a mobile computing device, and a thin-client computing device.

Fig. 13 depicts aspects of a system 1300 including a personal computing device 1302, the personal computing device 1302 being used in conjunction with a neurostimulation system 1303, the neurostimulation system 1303 being a neurostimulation system as described above. Personal computing device 1302 is as generally described in connection with fig. 12. In one aspect, personal computing device 1302 includes: a circuit 1304 for receiving the neural activity signal 1306, a circuit 1308 for determining a neural stimulation control signal 1310 based at least in part on the neural activity signal 1306, and a circuit 1312 for outputting the neural stimulation control signal 1310 to a neural stimulation device 1314. In an aspect, the neural activity signal 1306 is sensed by the neural signal sensor 1315 and is indicative of a physiological state of the subject. The neural activity signal 1306 may be an unprocessed neural signal, or the neural activity signal 1306 may have undergone various types and amounts of signal processing and/or analysis (including but not limited to filtering, amplification, analog-to-digital conversion, signal averaging, conversion from time domain to frequency domain, feature extraction, etc.). The neural activity signals 1306 may include neural activity sensed from one or more neural signal sensors 1315 (which may be, for example, electroencephalographic sensors or electrooculographic sensors). Neural activity signal 1306 may include information derived from or associated with the sensed neural signal, and may include or be accompanied by additional information identifying the type of signal, the type of processing the signal undergoes, data formatting, device settings used during acquisition of the neural signal, and so forth. The neural signal sensor 1315 is a component of the neural stimulation system 1303 and may be a component of the neural stimulation device 1314 or used with the neural stimulation device 1314 as described above. Neurostimulation device 1314 includes an external neurostimulator 1316 configured to be carried on a pinna of a subject. The neural stimulation control signal 1310 is configured to control delivery of neural stimulation configured to activate at least one sensory nerve fiber innervating at least a portion of a pinna by an external neural stimulator 1316.

Neural activity signal input 1304 (the circuitry for receiving neural activity signal 1306) includes, for example, headphone jack 1318, data input 1320, wireless receiver 1322 or network connection 1324. In aspects, the neural activity signal input 1304 includes a signal for receiving signals from a body local area network, or wide area network.

The neural stimulation control signal determination circuit 1308 includes one or more of: an amplitude determination circuit 1326 for determining the neural stimulation amplitude, a frequency determination circuit 1328 for determining the neural stimulation frequency, a waveform determination circuit 1330 for determining the neural stimulation waveform, a pattern determination circuit 1332 for determining the neural stimulation pattern, or a duration determination circuit 1333 for determining the neural stimulation duration. In one aspect, personal computing device 1302 includes data storage circuitry 1334 for storing data on the data storage device, data storage circuitry 1334 including memory 1336 and circuitry for accessing data stored therein. Memory 1336 may contain stored preprogrammed stimulation patterns and waveforms and neurostimulation parameter values from which neurostimulation may be calculated. In one aspect, system 1300 includes a data storage circuit 1334 for storing data representing neurostimulation control signals 1338 on personal computing device 1302. In an aspect, the system 1300 includes a data storage circuit 1334 for storing data representative of prior neural activity 1340 on the personal computing device 1302. In an aspect, the neural activity prediction circuit 1342 predicts a future neural activity signal based on a previous neural activity signal.

In an aspect, system 1300 includes an auxiliary stimulus determination circuit 1344 for determining an auxiliary stimulus based on the neural activity signal 1306. In an aspect, the auxiliary stimulation determination circuit 1344 determines the auxiliary stimulation control signal 1346 based on the previous neural activity signal 1340.

In an aspect, the system 1300 includes a reporting circuit 1348 for providing a report 1350 to at least one recipient. The reporting circuitry 1348 may cause the report 1350 to be provided via the user interface 1214 (as described in connection with fig. 12) or via a computing network (accessed via the communication circuitry 1218). In an aspect, report 1350 is provided to the subject using neurostimulation device 1314. On the other hand, the report 1350 is provided to other parties, such as a healthcare provider, an insurance company, a service provider (e.g., a business or other entity that provides services related to the neurostimulation device or to monitoring usage of the neurostimulation device). In an aspect, the report 1350 is provided to at least one social media contact (or "friend") or peer of the subject, e.g., via a social network. In one aspect, the recipient is a computing system, e.g., a computing system for storing and/or processing healthcare information. In various aspects, anonymization circuit 1352 is used to provide reports in an anonymous form (e.g., where information identifying the subject is removed therefrom). The reporting circuitry 1326 may include circuitry for including various information in the report 1350, such as information related to the neural activity signal 1306 or information derived therefrom, the neural stimulation control signal 1310, settings for the neural stimulation device 1314 or the personal computing device 1302, stored neural activity data 1340, auxiliary input signals 1354, and auxiliary stimulation control signals 1346. In one aspect, the system 1300 includes an auxiliary stimulation control signal output circuit 1356 for delivering an auxiliary stimulation control signal 1346 to the auxiliary stimulator 1358. Auxiliary stimulator 1358 may be any type of stimulator such as auxiliary stimulator 818 described in conjunction with fig. 7.

In an aspect, system 1300 includes an auxiliary signal input 1360 for receiving auxiliary input signals 1354 at personal computing device 1302. In an aspect, the neural stimulation control signal determination circuit is configured to determine the neural stimulation control signal 1310 based at least in part on the auxiliary input signal 1354. The auxiliary input signal may represent a physiological parameter of the subject or an environmental parameter of the subject, and may include: signals sensed from sensors on the neurostimulation device 1314 or associated with the neurostimulation device 1314 or sensors in the subject's environment, and/or parameters or values derived from these sensed signals. In one aspect, the auxiliary input signal is indicative of a user input provided by the subject. In one aspect, the auxiliary input signal 1354 may be received via a user input 1362 in the user interface 1214.

In an aspect, system 1300 includes circuitry for presenting a recommendation to a subject. The suggestion may be presented to the subject via user output 1364 of user interface 1214 (e.g., via audio output 1366 and/or graphical display 1368), or sent to neurostimulation device 1303 and presented via a user interface on neurostimulation device 1303. In an aspect, the system 1300 includes a suggestion receiving circuit 1370 for receiving suggestions 1372 at the personal computing device 1302. For example, in an aspect, the suggestion reception circuitry 1370 receives the suggestion 1372 via a computing network. In aspects, the suggestions 1372 are received, for example, from healthcare providers, insurance companies, service providers, consultants, computing-based systems (including, for example, artificial intelligence), or social media sources. In various aspects, the suggestion reception circuitry 1370 is configured to receive suggestions from particular sources and identify the sources of the suggestions and respond differently according to the sources of the suggestions, for example by receiving code with the suggestions that indicates the sources of the suggestions (e.g., particular healthcare providers, rather than social media sources). For example, the advice receiving circuitry 1370 may be configured such that advice from more trusted sources may be more quickly or significantly presented to the subject, while advice from undesired sources may be prevented. The recommendation 1372 may relate to a configuration of the neurostimulation control signal 1319 or the auxiliary stimulation control signal 1346. In other aspects, the recommendations 1372 relate to one or more of a consumer product, service, user experience, user activity, or tissue that may be of interest to the subject, for example, because these recommendations will enhance or adapt to the effect of the neural stimulation received by the subject, or relate in some other way to the neural stimulation or a condition that it is intended to treat. For example, the advice may be for software to store, present, share, or report stimulation data or health data, or for an organization to provide counseling to individuals with a particular condition. In an aspect, the user input 1362 is configured to receive an accept/reject signal 1374 from the subject regarding acceptance or rejection of the suggestion 1372.

In an aspect, the system 1300 includes patch or update receiving circuitry 1376 for receiving patches/updates 1378 at the personal computing device 1302. Patch/update 1378 includes a software patch or update for software located on personal computing device 1302 or neurostimulation device 1314, and may be received, for example, from the manufacturer of neurostimulation device 1314, from a service provider, etc. In one aspect, the personal computing device 1302 includes an update circuit 1380, the update circuit 1380 for applying patches or updates to software installed on the personal computing device 1302 or software installed on the neurostimulation device 1314 by sending an update signal 1382 to the neurostimulation system 1303. In one aspect, the update circuit 1380 also enables updating a configuration of at least one of the neurostimulation device and the personal computing device, the configuration being related to operation of the neurostimulation device. In an aspect, the update circuit 1380 may be configured to update the configuration of at least one of the neurostimulation device and the personal computing device based on historical data (e.g., historical data stored in the memory 1336). In another aspect, the update circuit 1380 is configured to update the configuration based on at least one instruction 1384. In one aspect, the instructions 1384 are received through a user input 1362 of the personal computing device 1302. In another aspect, instructions 1384 are received from a computer network (e.g., from a remote device or system via data input such as I/O892 shown in FIG. 8). In aspects, the instructions 1384 are received, for example, from a healthcare provider, insurance company, or service provider.

In another aspect, the update circuit 1380 is configured to update the configuration of at least one of the neurostimulation device and the personal computing device based on the at least one suggestion 1372. As described above, the suggestion 1372 is received by the suggestion receiving circuit 1370 and may be received from a consultant, from a computing-based system (e.g., artificial intelligence, a machine learning system, or a search engine based on data-driven techniques), or from a social media source (e.g., in various aspects, the suggestion is based on at least one preference of at least one social media contact, peer, or character model of the subject). Further, the accept/reject input 1374 is an acceptance or rejection of the recommendation received by the user interface 1214 from the subject, and the update circuit 1380 updates the configuration in response to the subject accepting the recommendation (if the recommendation is rejected, no update is made in response to the recommendation). Alternatively, the acceptance or rejection of the recommendation may be provided by the caregiver of the subject through either user interface 1214 or through data entry by a remote device or system. The update circuit 1380 updates the configuration in response to acceptance of the advice by a caregiver of the subject. In another aspect, the update circuit 1380 is configured to update the configuration of at least one of the neurostimulation device and the personal computing device based on the environmental parameter (based on the auxiliary input signal 1354 received at the auxiliary signal input 1360). In another aspect, the update circuit 1380 is configured to automatically update the configuration of at least one of the neurostimulation device and the personal computing device. For example, in an aspect, the configuration is automatically updated according to a schedule (e.g., when the time and/or date indicated by clock/timer 1386 matches the update time/date in schedule 1388 stored in memory 1336).

In an aspect, neural activity signal input 1304 includes circuitry that receives neural activity signal 1306 via a secure connection. In an aspect, the neural control signal output 1312 includes circuitry for outputting the neural stimulation control signal 1346 via a secure connection. The secure connection may include, for example, being provided through the use of an encrypted signal.

In one aspect, the system 1300 includes output circuitry 1390 for presenting information to the subject via the user interface 1214, the output circuitry 1390 including, for example, an audio output 1366, a graphical display 1368, an alphanumeric display 1392, a touch screen 1394, or other user interface device, as known to those of ordinary skill in the art.

In an aspect, system 1300 includes customization circuitry 1396. For example, the customization circuitry 1396 customizes one or both of the information or the format of the information presented through the user interface 1214 to the subject, e.g., according to user preferences.

In an aspect, system 1300 includes authentication circuitry 1398 for receiving credential 1400 that indicates that the subject is an authorized user. In an aspect, the output circuitry 1390 presents information to the subject via the user interface 1214 only after receiving the credential 1400 that the subject is an authorized user. In various aspects, the authentication circuit 1398 receives, for example, a password, a personal identification number, a biometric, or a card authentication.

In an aspect, the output circuitry 1390 includes an output format circuit 1402 for presenting information to the subject via the user interface 1214 in a graphical format that simulates the graphical format of an audio player, in a graphical format that simulates the graphical format of a mobile phone, or in any other graphical format that mimics the graphical format of a familiar user interface. This allows the subject to discretely use the neurostimulation device and present to observe the effects (imprints) of the personal computing device acting as a mobile phone or audio player rather than being used in conjunction with the neurostimulation device. In an aspect, in response to input signal 1404, output circuit 1390 changes or stops presenting information to the subject via the user interface. For example, the output circuitry 1390 switches between a first graphical format and a second graphical format on the user interface 1214 in response to the input signal 1404. For example, a first graphical format may present information related to neural stimulation, while a second graphical format may simulate the format of a mobile phone or audio player. In an aspect, input signal 1404 is a user input signal received, for example, via user interface 1214. In another aspect, input signal 1404 is a sensed environmental signal indicative of the presence of another person (e.g., an audio input signal received through auxiliary input signal 1354 that includes detected sounds of other persons). In an aspect, the input signal 1404 indicates time (e.g., a signal received from a clock/timer 1386 on the personal computing device 1302).

In an aspect, the neural stimulation control signal determination circuitry 1308 modulates the neural stimulation control signal 1310 in response to an override signal (override signal). For example, in an aspect, the override signal is an input signal 1404 received through a user input 1362. In one aspect, the override signal is an auxiliary input signal 1354 received through the auxiliary signal input 1360. In one aspect, the override signal originates from a sensor that senses a physiological parameter (e.g., heart rate). In the event that the physiological parameter indicates an unsafe condition (e.g., the heart rate is too high or too low), the neural stimulation control signal determination circuit 1308 modulates the neural stimulation control signal 1310 to stop the generation of neural stimulation. For example, in various aspects, the override signal originates from a sensor that is responsive to sensing the presence of a person other than the subject in the vicinity of the subject, or responsive to sensing that the external neural stimulator is not properly positioned on the pinna of the subject. In an aspect, the neural stimulation control signal determination circuit 1308 modulates the neural stimulation control signal 1310 to stop the generation of neural stimulation. In an aspect, the neural stimulation control signal determination circuit 1308 modulates the neural stimulation control signal 1310 to change the intensity of the neural stimulation. In addition to adjusting or stopping neural stimulation in response to an override condition (e.g., a physiological parameter indicating an unsafe condition, incorrect positioning of an external neural stimulator, etc.), a notification of the override condition may be sent to the subject and/or a healthcare provider or other party to prompt the recipient of the notification to take corrective action, or to include the information into the medical record of the subject.

In an aspect, the auxiliary signal input 1360 is adapted to receive a position signal indicative of a position of the external neurostimulator relative to a pinna of the subject. In this regard, the system 1300 may further include a notification circuit 1406, the notification circuit 1406 for communicating a notification to the subject indicating that the external neural stimulator should be repositioned. In one aspect, the notification circuitry 1406 comprises circuitry for delivering notifications via a graphical display 1368 of the personal computing device 1302. In one aspect, the notification circuitry 1406 includes circuitry for delivering an audible alarm via the audio output 1366 of the personal computing device or by generating the appropriate audio output signal 1408 for driving the generation of an audible alarm by the sound source 1410 on the neurostimulation device 1314. In an aspect, the notification circuitry 1406 comprises circuitry for communicating a voice message (e.g., a preset message retrieved from the memory 1336). In another aspect, notification circuitry 1406 includes circuitry for storing information indicating that stimulator 1316 is improperly located in a data storage location (e.g., memory 1336) in personal computing device 1302. In another aspect, notification circuit 1406 provides for storing information indicating that stimulator 1316 is incorrectly positioned in a data storage location in neurostimulation device 1314 (e.g., by sending such information to neurostimulation device 1314).

In one aspect, system 1300 includes circuitry for outputting an audio output signal via an audio output 1366 of personal computing device 1302 or via a sound source 1410 of neurostimulation device 1314, where the audio output signal drives the delivery of sound through the sound source to the ear of the subject. In an aspect, the output circuit 1390 is to output an audio output signal via an audio output 1366 of the personal computing device. In an aspect, communication circuitry 1218 is used to send audio output signal 1408 to acoustic source 1410 on neurostimulation device 1314. Alternatively, communication circuitry 1218 may be used to communicate the audio output signal to a different sound source than the neurostimulation device (e.g., a sound source included in the device used by the subject but not included in the neurostimulation device). In an aspect, the output circuitry 1390 retrieves audio signals from a data storage location (e.g., memory 1336) on the personal computing device 1302 and generates audio output signals based on the retrieved audio signals. In another aspect, system 1300 includes an audio receiver 1412 for receiving an audio input signal 1414 from a telecommunications network. For example, in various aspects, the audio input signal 1414 is a broadcast radio signal, a network broadcast audio signal, or a mobile phone signal.

In one aspect, the system 1300 includes a prioritization circuit 1416 for prioritizing the transmission of the neurostimulation control signals relative to the audio output signals (for the audio output signals 1408 transmitted to the sound source 1410 and/or the audio output signals transmitted via the audio output 1366 on the personal computing device 1302). In an aspect, the prioritization circuit 1416 automatically interrupts the output of the neural stimulation control signal 1310 and begins the output of the audio output signal in response to the receipt of the audio input signal 1414. On the other hand, if neural stimulation is being delivered, the prioritization circuit 1416 automatically decreases the audio input signal 1414. In another aspect, the prioritization circuit 1416 provides circuitry for outputting an audio output signal concurrently with the neural stimulation control signal 1310. In another aspect, the prioritization circuit 1416 provides for switching between outputting the audio output signal and outputting the neurostimulation control signal 1346. Switching may occur in response to user input received via user input 1362 or in response to sensor input received, for example, via secondary signal input 1360. In an aspect, the prioritization circuit 1416 switches between outputting the audio output signal and outputting the neurostimulation control signal 1310 in response to input from the clock/timer 1386 according to a schedule (e.g., stored in the memory 1336). In an aspect, the prioritization circuit 1416 switches between outputting the audio output signal and outputting the neurostimulation control signal in response to receiving the audio input signal 1414 from the telecommunications network. The prioritization circuit 1416 may be configured to give higher priority to the output neurostimulation control signals than to the output audio output signals, or to give higher priority to the output audio output signals than to the output neurostimulation control signals. The priority of the signal may be determined by the preference of the subject. For example, the subject may consider receiving a telephone call via his or her mobile phone to have a higher priority than continuing to receive neural stimulation, and thus system 1300 may be configured such that neural stimulation is interrupted when a telephone call is received. Alternatively, the subject may prefer that the neurostimulation session (session) not be interrupted, and the system 1300 may be configured such that no phone call will be received when neurostimulation occurs. In other aspects, the subject can provide input at the user interface 1214 (e.g., by pressing a button) to switch between receiving neural stimulation and listening to music, as preferred. In another aspect, system 1300 is configured to deliver neural stimulation in conjunction with music.

Fig. 14 is a flow chart of a method 1450 relating to use of the system including a personal computing device as shown in fig. 13. The method 1450 includes: a neural activity signal is received at a personal computing device, the neural activity signal being indicative of a physiological state of a subject, as shown at 1452. Further, method 1450 includes determining a neural stimulation control signal based at least in part on the neural activity signal, as shown at 1454, and outputting the neural stimulation control signal from the personal computing device to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulation control signal is configured to control delivery of neural stimulation by the external neural stimulator, the neural stimulation configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, as shown at 1456. In one aspect, determining the neural stimulation control signal includes determining a stimulation pattern. In various aspects, the method 1450 includes additional steps related to system functionality described in more detail in connection with fig. 13. For example, in an aspect, method 1450 includes providing a report to at least one recipient, as shown at 1458. In one aspect, method 1450 includes determining a secondary stimulation control signal suitable for controlling delivery of secondary stimulation to the subject, and delivering the secondary stimulation control signal to a secondary stimulator, as shown at 1460. For example, in one aspect, the secondary stimulator includes a gaming device, and the secondary stimulus control signal controls operation of the gaming device. In another aspect, the auxiliary stimulator includes a computing system configured to deliver a virtual therapist experience, and the auxiliary stimulation control signal controls operation of the virtual therapist. In another aspect, the secondary stimulus includes an interactive activity delivered by the computing device, and the secondary stimulus control signal controls operation of the computing device.

In an aspect, method 1450 includes receiving an auxiliary input signal at the personal computing device and determining a neurostimulation control signal based at least in part on the auxiliary input signal, as shown at 1462. For example, in one aspect, the auxiliary input signal represents user input provided spontaneously by the subject. Other auxiliary input signals are described above.

In one aspect, method 1450 includes presenting recommendations to the subject, as shown at 1464. The method 1450 may also include receiving the suggestion at the personal computing device, as described above in connection with fig. 13.

In one aspect, method 1450 includes receiving a patch or update at the personal computing device, the patch or update relating to operation of the neurostimulation device, as shown at 1466. In one aspect, a patch or update is used to install software on a personal computing device. In another aspect, the patch or update is for software installed on the neurostimulation device, in which case the method 1450 may further include transmitting the patch or update to the neurostimulation device.

In an aspect, the method 1450 includes updating a configuration of at least one of the neurostimulation device and the personal computing device, the configuration being related to operation of the neurostimulation device, as shown at 1468. As described above, the configuration is based on at least one instruction. In another aspect, in response to receiving input regarding acceptance of the recommendation by the subject or a caregiver of the subject, the configuration is updated based on at least one recommendation.

In one aspect, method 1450 includes presenting information to the subject via a user interface, as shown at 1470. The method may further include altering or interrupting presentation of information to the subject via the user interface in response to the input signal. In one aspect, the method 1450 includes modulating the neurostimulation control signal in response to the override signal, as shown at 1472.

In one aspect, method 1450 includes receiving a position signal indicative of a position of an external neural stimulator relative to a pinna of the subject, as shown at 1474. The method 1450 may also include delivering a notification to the subject indicating that the external neural stimulator should be repositioned. Other method aspects are discussed in conjunction with fig. 13.

Fig. 15 is a block diagram of a computer program product 1500 for implementing the method as described in connection with fig. 14. The computer program product 1500 includes a signal bearing medium 1502, the signal bearing medium 1502 bearing: one or more instructions for receiving a neural activity signal indicative of a physiological state of a subject; one or more instructions for determining a neural stimulation control signal based at least in part on the neural activity signal; and one or more instructions for outputting a neural stimulation control signal to a neural stimulation device, the neural stimulation device comprising an external neural stimulator configured to be carried on a pinna of a subject, wherein the neural stimulation control signal is configured to control delivery of neural stimulation by the external neural stimulator, the neural stimulation configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, as shown at 1504. The signal bearing medium 1502 may be, for example, a computer readable medium 1506, a recordable medium 1508, a non-transitory signal bearing medium 1510, or a communication medium 1512, examples of which are described above.

Fig. 16 is a block diagram of a system 1600 that includes a personal computing device 1602 and an external neurostimulator 1604, the external neurostimulator 1604 including a portion of a neurostimulation device 1606 and a neurostimulation system 1608. The personal computing device 1602 is as generally described in connection with fig. 12. In an aspect, the system 1600 includes a personal computing device 1602, the personal computing device 1602 including a physiological activity input circuit 1610 for receiving a physiological activity signal 1612 at a personal computing device 1062. The physiological activity signal 1612 is sensed by a physiological sensor 1614 in the neurostimulation system 1608 and is indicative of the physiological state of the subject. The physiological sensor 1614 can be any of various types of physiological sensors, for example, as described in connection with physiological sensor 758 in fig. 7. In various aspects, the physiological activity signal 1612 represents heart rate (and in some cases heart rate rhythm variability), blood pressure, perspiration, skin conductance, respiration, pupil dilation, digestive tract activity, or piloerection. In some aspects, the physiological activity signal 1612 is a neural activity signal, such as an electroencephalogram signal or an electrooculogram signal. The physiological activity signal 1612 may be an electromyography signal (indicative of muscle activity of the subject) or an electrocardiogram signal (indicative of heart activity of the subject). The physiological activity signal 1612 can be an unprocessed physiological signal, or the physiological activity signal 1612 can have been subjected to various types and amounts of signal processing and/or analysis (including but not limited to filtering, amplification, analog-to-digital conversion, signal averaging, conversion from the time domain to the frequency domain, feature extraction, and so forth). The physiological activity signal 1612 may include activity sensed from one or more physiological sensors 1614. The physiological activity signal 1612 may include information derived from or associated with the sensed physiological signal, and may include or be accompanied by additional information identifying the signal type, the type of processing the signal has undergone, data formatting, device settings used during acquisition of the physiological signal, and so forth. The personal computing device 1602 also includes a neurostimulation control signal determination circuit 1616 for determining a neurostimulation control signal 1618 based at least in part on the physiological activity signal 1612. The neural stimulation control signal 1618 is configured to control delivery of neural stimulation by the external neural stimulator 1604. In one aspect, the neural stimulation is configured to activate at least one sensory nerve fiber innervating at least a portion of a pinna. The personal computing device 1602 also includes a neurostimulation control signal output circuit 1620 for outputting the neurostimulation control signal 1618 from the personal computing device 1602 to the neurostimulation device 1606. The neurostimulation device 1606 includes an external neurostimulator 1604 configured to be carried on a pinna of a subject. The personal computing device 1602 also includes an output circuit 1390 for presenting information to the subject via a user interface 1364 (as described above in connection with fig. 13). The various elements of system 1600 are the same as like numbered elements of the systems shown in fig. 12 or 13 and will not be discussed in detail in connection with fig. 16. However, some components of system 1600 include different and/or additional features. For example, the data storage circuit 1334 is further adapted to store physiological activity data 1622 representative of the physiological activity signal 1612 in the memory 1336. In one aspect, the physiological activity prediction circuit 1624 predicts a future physiological activity signal based on a previous physiological activity signal. Further, the neural stimulation control signal determination circuit 1616 determines the neural stimulation based on the previous physiological activity signal. The secondary stimulation determination circuit 1344 is adapted to determine the secondary stimulation based on the physiological activity signal 1612 or a previous physiological activity signal (e.g., stored in memory 1336). As described above in connection with fig. 13, in an aspect, the auxiliary input signal 1354 is a physiological signal. It should be understood that the secondary input signal 1354 in this context will be the secondary physiological signal and the physiological activity signal 1612 will be the primary physiological signal. In an aspect, the physiological activity input circuitry 1610 includes circuitry for receiving a physiological activity signal 1612 via a secure connection. In an aspect, the neurostimulation control signal output 1620 comprises circuitry for outputting the neurostimulation control signal 1618 via a secure connection.

Fig. 17 is a flow chart of a method 1700 related to use of the system shown in fig. 16. In one aspect, method 1700 includes: receiving a physiological activity signal at a personal computing device, the physiological activity signal indicative of a physiological state of a subject, as shown at 1702; determining a neural stimulation control signal based at least in part on the physiological activity signal, as shown at 1704; outputting the neural stimulation control signal from a personal computing device to a neural stimulation device, the neural stimulation device comprising an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulation control signal is configured to control delivery of neural stimulation by the external neural stimulator, the neural stimulation configured to activate at least one sensory nerve fiber innervating at least a portion of a pinna, as shown at 1706; and presenting the information to the subject via a user interface, as shown at 1708. Other method aspects are discussed in conjunction with fig. 14 and 16.

Fig. 18 is a block diagram of a computer program product 1800 for implementing a method as described in connection with fig. 17. The computer program product 1800 includes a signal bearing medium 1802, the signal bearing medium 1802 bearing: one or more instructions for receiving a physiological activity signal, the physiological activity signal indicative of a physiological state of a subject; one or more instructions for determining a neural stimulation control signal based at least in part on the physiological activity signal; one or more instructions for outputting a neurostimulation control signal to a neurostimulation device, the neurostimulation device comprising an external neurostimulator configured to be carried on an ear of a subject, wherein the neurostimulation control signal is configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber, the at least one sensory nerve fiber innervating at least a portion of a pinna; and one or more instructions for presenting information to the subject via the user interface, as shown at 1804. The signal bearing medium 1802 may be, for example, a computer readable medium 1806, a recordable medium 1808, a non-transitory signal bearing medium 1810, or a communication medium 1812, examples of which are described above.

Fig. 19 is a block diagram of a system 1900. Fig. 19 is similar to the system shown in fig. 13 and 16, and like numbered system components described in connection with these figures will not be described again in connection with fig. 19. In one aspect, the system 1900 includes a personal computing device 1902, the personal computing device 1902 including a physiological activity input circuit 1610 for receiving a physiological activity signal at the personal computing device 1902, the physiological activity signal 1612 indicative of a physiological state of the subject. The system 1900 also includes a neural stimulation control signal determination circuit 1616 that determines a neural stimulation control signal 1618 based at least in part on the physiological activity signal 1612. Additionally, the system 1900 includes a neurostimulation control signal output circuit 1620 for outputting the neurostimulation control signal 1618 from the personal computing device 1902 to the neurostimulation device 1904. Neurostimulation device 1904 includes an external neurostimulator 1604 configured to be carried on a pinna of a subject, wherein neurostimulation control signal 1618 is configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber that innervates at least a portion of the pinna. The system 1900 also includes an audio output circuit 1908 for outputting an audio output signal 1910 via an audio output 1366 of the personal computing device 1902. In one aspect, system 1900 includes circuitry for delivering an audio output signal to an acoustic source 1910 on a neurostimulation device. In another aspect, the system 1900 includes circuitry for delivering the audio output signal 1910 to a sound source 1912 that is distinct from the neural stimulation device 1904. For example, acoustic source 1912 may be an acoustic source in the environment of the subject rather than on the neurostimulation device, including but not limited to an acoustic source on personal computing device 1902, built-in to personal computing device 1902, or associated with personal computing device 1902. In one aspect, the system 1900 includes a data storage circuit 1334 for retrieving stored audio signals 1914 from a data storage location (memory 1336) on the personal computing device 1902. In one aspect, the system 1900 includes an audio receiver 1412 for receiving an audio input signal from the telecommunications network 1918. For example, in various aspects, the audio input signal is a broadcast radio signal 1920, a network broadcast audio signal 1922, or a handset signal 1024.

In one aspect, system 1900 includes a prioritization circuit 1416 that prioritizes between delivery of neural stimulation and delivery of audio output signals based on system settings and/or preferences of the subject. For example, the prioritization circuit 1416 provides for automatically stopping the output of the neural stimulation control signal and starting the output of the audio output signal in response to receipt of the audio input signal, automatically lowering the audio input signal if neural stimulation is currently being delivered, or outputting the audio output signal concurrently with the neural stimulation control signal. In other aspects, the prioritization circuit 1416 provides for switching between outputting the audio output signal and outputting the neurostimulation control signal, such as in response to a user input or a sensor input, according to a schedule, or in response to receiving an audio input signal (e.g., a telephone call) from a telecommunications network. The prioritization circuit 1416 may be configured to give higher priority to the output neurostimulation control signals over the output audio output signals, or to give higher priority to the output audio output signals over the output neurostimulation control signals, depending on the preference of the subject or other considerations.

Fig. 20 is a flow chart of a method 2000 related to use of the system shown in fig. 19. In one aspect, the method 2000 includes: receiving, at a personal computing device, a physiological activity signal, the physiological activity signal indicative of a physiological state of a subject, as shown in 2002; determining a neural stimulation control signal based at least in part on the physiological activity signal, as shown at 2004; outputting the neurostimulation control signal from a personal computing device to a neurostimulation device comprising an external neurostimulator configured to be carried on a pinna of the subject, wherein the neurostimulation control signal is configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber that innervates at least a portion of a pinna, as shown at 2006; and outputting the audio output signal via an audio output of the personal computing device, as shown at 2008. Other method aspects are discussed in conjunction with fig. 14 and 19.

Fig. 21 is a block diagram of a computer program product 2100 for implementing the method as described in connection with fig. 20. The computer program product 2100 includes a signal bearing medium 2102, the signal bearing medium 2102 bearing: one or more instructions for receiving, at a personal computing device, a physiological activity signal indicative of a physiological state of a subject; one or more instructions for determining a neural stimulation control signal based at least in part on the physiological activity signal; one or more instructions for outputting a neurostimulation control signal from a personal computing device to a neurostimulation device, the neurostimulation device comprising an external neurostimulator configured to be carried on a pinna of the subject, wherein the neurostimulation control signal is configured to control delivery of neurostimulation by the external neurostimulator, the neurostimulation configured to activate at least one sensory nerve fiber innervating at least a portion of a pinna; and one or more instructions for outputting the audio output signal via an audio output of the personal computing device, as shown at 2104. The signal bearing medium 2102 may be, for example, a computer readable medium 2106, a recordable medium 2108, a non-transitory signal bearing medium 2110, or a communication medium 2112, examples of which are described above.

Fig. 22 is a block diagram of a system 2200 that includes a personal computing device 2202 for use in combination with a wearable mechanical stimulation device 2204. Fig. 22 is similar to the system depicted in fig. 13, 16, and 19, and like-numbered system components described in connection with these figures will not be described again in connection with fig. 22. The personal computing device 2202 includes a vibration stimulation control signal determination circuit 2206 to determine the vibration stimulation control signal 2208 and a vibration stimulation control signal output circuit 2210 to output the vibration stimulation control signal 2208 to the wearable mechanical stimulation device 2204. The wearable mechanical stimulation device 2204 includes a vibrating mechanical stimulator 1002 configured to be carried on a pinna of a subject, wherein the vibrating stimulation control signal is configured to control delivery of a vibrating stimulus by the vibrating mechanical stimulator 1002, the vibrating stimulus configured to activate at least one mechanoreceptor having a receptive field on at least a portion of the pinna. In an aspect, the wearable mechanical stimulation device 2204 is a wearable neural stimulation device 1000 of the type discussed in connection with fig. 10, and may be considered a variation of the wearable neural stimulation device 1202 depicted and discussed in connection with fig. 12. Additionally, in various aspects, the system 2200 includes additional components, such as included in the neurostimulation system 1200 described in connection with fig. 7, 10, and/or 12, including, but not limited to, a sensor 1018 for detecting the input signal 1354, a user interface 1221, a position sensor 864, an auxiliary stimulator 818, and an acoustic source 856. The personal computing device 2202 may be any of the various types of personal computing devices described in connection with fig. 12, such as a personal digital assistant, a personal entertainment device, a mobile phone, a laptop computer, a desktop personal computer, a wearable computing device, a networked computer, a computing system comprised of a cluster of processors, a computing system comprised of a cluster of servers, a workstation computer, or a desktop computer. Data storage circuitry 1334, including memory 1336 on the personal computing device 2202, may be used to store data, instructions, parameters, as described elsewhere herein, including, but not limited to, stimulation patterns 2212a, 2212b, and 2212c representing vibromechanical stimulation to be delivered under control of the vibro-stimulation control signal 2208. In one aspect, the vibratory stimulation control signal 2208 is configured to cause delivery of one of a plurality of preprogrammed stimulation patterns (e.g., selected from among the stimulation patterns 2212a, 2212b, and 2212c stored in memory 1336). In one aspect, the vibration stimulation control signal 2208 is determined by a vibration stimulation control signal determination circuit 2206. In various aspects, the vibratory stimulation control signal determination circuit 2206 includes an amplitude determination circuit 2214, a frequency determination circuit 2216, a waveform determination circuit 2218, a pattern determination circuit 2220, or a duration determination circuit 2222 for determining various aspects of the vibratory stimulation control signal 2208, the vibratory stimulation control signal 2208 determining the mechanical stimulation delivered by the vibrating mechanical stimulator 1002. If the position signal 2224 from the position sensor 864 indicates that the vibromechanical stimulator 1002 is not properly positioned on the subject's ear, a notification is provided to the subject, e.g., via the notification circuit 1406, instructing the subject to reposition the vibromechanical stimulator 1002.

Fig. 23 is a flow chart of a method 2300 directed to using the system shown in fig. 22. In one aspect, method 2300 includes: determining, with a stimulus control circuit in the personal computing device, a vibration stimulus control signal, as shown at 2302; and outputting the vibration stimulation control signal from the personal computing device to a wearable mechanical stimulation device, the wearable mechanical stimulation device comprising a vibration mechanical stimulator configured to be carried on a pinna of a subject, wherein the vibration stimulation control signal is configured to control delivery of vibration stimulation by the vibration mechanical stimulator, the vibration stimulation configured to activate at least one mechanoreceptor with a receptive field on at least a portion of the pinna, as shown at 2304.

Fig. 24 is a block diagram of a computer program product 2400 for implementing the method as described in connection with fig. 23. The computer program product 2400 includes a signal bearing medium 2402, the signal bearing medium 2402 bearing: one or more instructions for determining a vibration stimulation control signal configured to control delivery of vibration stimulation by a vibrating mechanical stimulator, the vibration stimulation configured to activate at least one mechanoreceptor having a receptive field on at least a portion of a pinna of a subject; and one or more instructions for outputting a vibro-stimulation control signal to a wearable mechanical stimulation device comprising at least one vibro-mechanical stimulator, as shown at 2404. The signal bearing medium 2402 may be, for example, a computer readable medium 2406, a recordable medium 2408, a non-transitory signal bearing medium 2410, or a communication medium 2412, examples of which are described above.

In some aspects, wearable neurostimulation devices and systems as described above are used in conjunction with a remote system. For example, fig. 2A and 2B illustrate a neurostimulation system used in combination with remote system 26 via communication network 218. Fig. 12 depicts communications between a wearable neurostimulation device 1202 and/or a personal computing device 1204 forming a neurostimulation system 1200 and a remote system 1224. Additionally, as shown in fig. 13, information may be sent from the remote system to the personal computing device 1302, including, for example, recommendations 1372, patches/updates 1374, or instructions 1384. Fig. 25 provides more detailed information regarding such a remote system 2500. The remote system 2500 includes a computing system 2502. The computing system 2502 includes an identification circuit 2504 for receiving identification information 2506 identifying at least one of a subject 2508 and a neural stimulation device 2510 associated with the subject 2508. Neurostimulation device 2510 is a neurostimulation device configured to be carried on a subject's ear and including external neurostimulator 2512. System 2502 includes a recommendation circuit 2520 for providing a recommendation 2522 related to a treatment regimen to subject 2508, wherein the treatment regimen includes delivering to the subject neural stimulation configured to activate at least one sensory nerve fiber innervating skin on or near an ear of the subject using external neural stimulator 2512. In one aspect, recommendation circuit 2520 utilizes a database to generate recommendations for combinations of treatments in a treatment plan, e.g., in a manner similar to that described in the following documents: U.S. patent 7,801,686 to Hyde et al, issued on 9/21/2010; U.S. patent 7,974,787 to Hyde et al, issued on 5.7.2011; U.S. patent 8,876,688 to Hyde et al, issued on 11/4/2014; U.S. patent publication 20090269329, 2009, 10, 29; U.S. patent publication 20090271009, 2009, 10, 29; and U.S. patent publication 20090271375, 2009, 10, 29, to Hyde et al, each of which is incorporated herein by reference.

In various aspects, neurostimulation device 2510 is any of the various types of neurostimulation devices described herein (e.g., described in conjunction with any of fig. 7, 10 or 12). In an aspect, the recommendation 2522 is sent to the local system 2524 and the identification information 2506 is received from the local system 2524. Local system 2524 includes neural stimulation device 2510 and other components at the location of subject 2508, including, but not limited to, auxiliary stimulator 2526, at least one sensor 2528 (e.g., environmental sensor 2530, physiological sensor 2532, or other sensors as described above). In an aspect, the local system 2524 includes a personal computing device 2534. The personal computing device 2534 may include, for example, at least one of a personal digital assistant, a personal entertainment device, a mobile phone, a laptop computer, a tablet personal computer, a wearable computing device, a networked computer, a workstation computer, and a desktop computer, as described above. In an aspect, the suggestion 2522 is presented to the subject 2508, e.g., via a user interface of the personal computing device 2534, and a receipt or rejection of the suggestion is entered through the user interface of the personal computing device 2534 and sent as an accept/reject signal 2536 to the remote computing system 2502.

Auxiliary stimulator 2526, sensor 2528, and personal computing device 2534 are as described above, e.g., in connection with at least fig. 7 and 12. Signals containing information, instructions, data, etc. may be sent directly between neurostimulation device 2510 and computing system 2502, or information may be sent between computing system 2502 and personal computing device 2534 and then between personal computing device 2534 and neurostimulation device 2510. The transmission of signals (information, instructions, data, etc.) between the computing system 2502 and the local system 2524 may be via a wired or wireless communication link, e.g., via a computer or communication network. In an aspect, computing system 2502 is part of a computing network from which information 2536 is received from parties and/or entities including, but not limited to, for example, social media 2540, social media contacts 2542, a role model 2546 of a peer 2544 or subject 2508, insurance companies, service providers (e.g., healthcare providers or companies that provide various health or wellness-related services), and computing-based systems related to such service providers.

Computing system 2502 includes one or more computing devices described generally in connection with fig. 8. In one aspect, computing system 2502 includes update generation circuitry 2560 for generating a patch/update 2562 that is sent to local system 2524, patch/update 2562 being used to update software on personal computing device 2534 or neurostimulation device 2510. In an aspect, computing system 2504 includes auxiliary stimulation determination circuitry 2564 for determining auxiliary stimulation to be delivered in conjunction with neural stimulation, e.g., by auxiliary stimulator 2526. The auxiliary stimulus may be any of various types of stimulus, as described above. In one aspect, the computing system 2502 includes a data storage circuit 2566, the storage circuit 2566 storing information regarding, for example, one or more stimulation patterns 2570, subject response information 2572 received, for example, from the local system 2524, treatment protocol information 2574, or one or more reports 2576, in various aspects. In an aspect, the report 2576 is generated by the report circuitry 2578 and the report 2576 is stored in the data storage circuitry 2566 in addition to, or instead of, providing the report 2576 to the recipient.

Fig. 26 provides more detailed details of several aspects of fig. 25 regarding the information processed by system 2500 (specifically, the information included in identification information 2506, recommendations 2522, and treatment protocol information 2574).

In various aspects, identification information 2506 includes device information 2602 related to a neurostimulation device 2510, or subject information 2610 related to a subject. Device information 2602 includes, for example, device type information 2604, a device serial number 2606, or a device inventory number 2608. The subject information 2610 includes, for example, a name of the subject 2612, a username 2614 associated with the subject, an email address 2616 associated with the subject, a subject identification 2618 (e.g., an identification number, a code, etc.), or biometric information 2620 associated with the subject. In various aspects, subject identification 2618 may be input by the subject via user input, read with a barcode or RFID reader, received with an RF receiver, or the like.

Recommendations 2522 may include one or more recommendations for various aspects of the device and system configuration for delivering neural stimulation and for one or more additional stimuli or experiences to be presented to or experienced by the subject in association with the neural stimulation. In various aspects, 2522 is suggested a configuration for neural stimulation 2622 (e.g., stimulation amplitude 2624, frequency 2626, duration 2628, waveform 2630, or delivery pattern 2632). In various aspects, 2522 is proposed for auxiliary stimulation 2632 to be delivered in association with the neural stimulation. In various aspects, the auxiliary stimulus 2632 includes music, auditory stimuli, video stimuli, tactile stimuli, olfactory stimuli, medication, nutrition, auxiliary neural stimuli, experiences (including but not limited to virtual reality experiences, gaming experiences, virtual therapist experiences, augmented reality experiences, and/or interactive experiences). In aspects, suggestions 2522 are for product 2634, service 2636, activity 2638, experience 2640, or organization 2642. The suggestion may be a variety of experiences. In one aspect, the recommendation specifies one or more delivery modes of experiences. It should be understood that not all of the ancillary stimuli suggested for use in conjunction with neural stimulation are delivered by the neural stimulation system. Suggestions (e.g., suggestions for a product, service, experience, or organization) may be presented to the subject via the personal computing device in the form of links to related websites so that the subject may conveniently access the suggested product, service, experience, or organization as desired.

Therapy regime information 2574 includes, for example, neural stimulation information 2650 regarding neural stimulation, auxiliary stimulation information 2652 regarding auxiliary stimulation delivered in association with the neural stimulation, information 2654 regarding auxiliary data signals, which may specifically include neural sensor signal information 2656, physiological sensor signal information 2658, environmental sensor signal information 2660, motion sensor information 2662, or position sensor information 2664.

Fig. 27 is a flow chart of a method 2700 performed in conjunction with the system for providing advice to a subject shown in fig. 25. In one aspect, method 2700 includes: receiving, at a computing system (e.g., computing system 2502 in fig. 25), identification information identifying at least one of a subject and a neurostimulation device associated with the subject, the neurostimulation device configured to be carried on an ear of the subject and comprising an external neurostimulator, as shown at 2702; and communicating, from the computing system to a personal computing device (e.g., a personal computing device) used by the subject, a recommendation related to a treatment protocol that includes delivering, with the external neural stimulator, neural stimulation to the subject, the neural stimulation configured to activate at least one sensory nerve fiber that innervates skin on or near an ear of the subject, as shown at 2704.

In one aspect, receiving identification information at a computing system includes receiving information sent from a personal computing device. In one aspect, receiving the identification information at the computing system includes receiving information sent via a computing network. In one aspect, receiving the identification information at the computing system includes receiving information sent via a wireless network. In one aspect, providing a recommendation to the subject related to the treatment regimen includes sending the recommendation to a personal computing device, e.g., via a computing network or a wireless network.

In one aspect, a recommendation is received at a computing system from a healthcare provider. In another aspect, the recommendation is generated at the computing system, for example, by recommendation circuit 2520 as shown in fig. 25. The suggestion may be generated based on various types of information: for example, information about the subject's response to past treatment regimens (subject response information 2572 in fig. 25); information obtained through social media (e.g., information 2536 in fig. 25), which may include, for example, information regarding one or more preferences of a character model of one or more social media contacts, peers, or subjects); information from insurance companies; or information from a service provider. In an aspect, generating the suggestion includes generating the suggestion using a computing-based system 2552 (e.g., artificial intelligence, a machine learning system, or a search engine based on data-driven techniques). In one aspect, generating the recommendation includes generating the recommendation based on a predicted response of the subject to the treatment regimen.

In one aspect, method 2700 includes receiving information regarding whether the subject accepts or rejects the recommendation. In one aspect, method 2700 includes receiving credentials that indicate that the subject is an authorized user of the personal computing device. For example, the credentials may include a password, a PIN, biometric or card authentication, and/or credentials that indicate that the personal computing device is an authorized device.

In one aspect, method 2700 includes storing at least one parameter of the neural stimulation in a data storage location associated with a computing system (e.g., data storage circuitry 2566 of computing system 2502).

In this regard, the recommendation relates to at least one parameter of the neural stimulation, such as an amplitude, frequency, waveform or duration of delivery of the neural stimulation, or a stimulation pattern used to deliver the neural stimulation. The stimulation pattern may be, for example, a pre-programmed pattern, a continuous pattern, an intermittent pattern, a time-varying pattern, and/or a pulsed pattern. In one aspect, the recommendation specifies a selection of one of a plurality of stimulation modes.

In one aspect, receiving identification information at a computing system includes receiving information sent from a personal computing device.

In one aspect, the method 2700 includes communicating a report regarding the treatment plan to at least one recipient. In one aspect, the at least one recipient comprises, for example, the subject, a caregiver of the subject, at least one social media contact of the subject, at least one peer of the subject, at least one healthcare provider, or at least one insurance provider. In one aspect, the recipient is a computing system, e.g., a computing system for storing and/or processing healthcare information. In some cases, the report is anonymous, e.g., to protect the privacy of the subject. The report may include demographic information related to the subject, but not personally identifying information related to the subject. In one aspect, sending the report includes sending the report to a personal computing device. The report may include, for example, a neural stimulation control signal, a determined compliance of the subject with the treatment regimen, a determined efficacy of the treatment regimen, one or more system settings for controlling delivery of the neural stimulation, information retrieved from a data storage location associated with the computing system, and/or information about the delivered ancillary stimulation associated with the neural stimulation. Compliance of a subject and/or efficacy of a treatment regimen can be determined by directly querying the subject, by querying another party (e.g., a caregiver), or by making a determination based on a measured physiological parameter of the subject.

In one aspect, the method 2700 includes receiving a report regarding the treatment plan from the personal computing device. In one aspect, the method 2700 includes storing information related to the treatment plan (e.g., the treatment plan information 2574 described in connection with fig. 15 and 26) in a data storage location associated with the computing system.

In one aspect, the method 2700 includes receiving, at the computing system, information regarding a previously delivered therapy regimen. Further, the method can include receiving, at the computing system, information regarding the subject's response to the previously delivered therapy regimen.

In one aspect, method 2700 includes sending a patch or update from the computing system to the personal computing device. The patch or update may be for software installed on a personal computing device, or for software installed on an external neurostimulator.

In an aspect, method 2700 includes generating an update for the configuration of the neural stimulation. This may be done based on the subject's response to previous treatment regimens, based on environmental factors, or based on the subject's motion or position. In an aspect, for example, when an update is determined to be needed (based on subject response or sensed environmental factors), the update is automatically generated. In another aspect, the update is generated based on acceptance of the recommendation for the update by the subject.

FIG. 28 is a block diagram of a computer program product 2800 for implementing a method as described in connection with FIG. 27. The computer-program product 2800 includes a signal-bearing medium 2802, the signal-bearing medium 2802 bearing: one or more instructions for receiving identification information identifying at least one of a subject and a neurostimulation device associated with the subject, the neurostimulation device configured to be carried on an ear of the subject and comprising an external neurostimulator; and one or more instructions for providing a recommendation to a subject related to a treatment regimen, the treatment regimen comprising delivering, with an external neural stimulator, neural stimulation to the subject, the neural stimulation configured to activate at least one sensory nerve fiber that innervates skin on or near an ear of the subject, as shown at 2804. The signal bearing medium 2802 may be, for example, a computer readable medium 2806, a recordable medium 2808, a non-transitory signal bearing medium 2810, or a communication medium 2812, examples of which are described above.

Fig. 29 depicts an embodiment of a system 2900 for delivering neural stimulation in conjunction with providing therapeutic adjunctive stimulation. The system 2900 includes a fixation member 400 of the type shown in fig. 4A and 4B, the fixation member 400 having an ear canal insert 416 including a heart rate sensor (not shown in fig. 29) and stimulation electrodes 414A and 414B positioned to stimulate an auricle 2902 of a subject 2904. The system 2900 also includes a mobile telephone 2906 configured with application software 2908. The mobile phone 2906 and application software 2908 together form at least a physiological activity input circuit 2910, an auxiliary signal input 2912, a neurostimulation control signal determination circuit 2914, an auxiliary stimulation determination circuit 2916, and a reporting circuit 2918. The mobile phone 2906, along with application software 2908, forms a personal computing device that includes various circuitry (not all depicted in fig. 29), such as shown and described in connection with fig. 16.

The neurostimulation control signal determination circuit 2914 is for generating a neurostimulation control signal 2920, the neurostimulation control signal 2920 driving delivery of neurostimulation through the electrodes 414a and 414b, the auxiliary stimulus determination circuit 2916 is for generating an auxiliary stimulus control signal 2922, the auxiliary stimulus control signal 2922 controlling delivery of a therapeutic auxiliary stimulus while the subject 2904 is accepting stimulus delivered to the pinna 2902 in the example of fig. 29, the therapeutic auxiliary stimulus is provided in the form of a therapeutic application providing cognitive training and therapy through digital media.

A heart rate 2932 sensed with a heart rate sensor (e.g., an ECG sensor or a pulse oximetry sensor) in the ear canal insert 416 is provided to the physiological activity input circuit 2910. The heart rate of the subject is monitored during delivery of the neural stimulation in conjunction with the therapeutic auxiliary stimulation to track the effects of the stimulation and treatment over time. The amount of heart rate variability and the duration of heart rate variability and/or the change in heart rate variability over time may be monitored. Heart rate variability is an indicator of the balance between sympathetic and parasympathetic tone. Increased heart rate variability is associated with reduced inflammation and anxiety. In addition, the physiological data may be combined with the subject's interaction with the procedure. In one aspect, one or both of the neurostimulation control signal 2920 and the auxiliary stimulation control signal 2922 is modified (by the neurostimulation control signal determination circuit 2914 and the auxiliary stimulation determination circuit 2916, respectively) in response to the heart rate 2932 and the user input 2930. Physiological data regarding the subject's heart rate and data regarding the interaction of the subject 2904 with the application software 2908 may be included in a report 2934, which report 2934 may be sent to the subject's healthcare provider or psychologist via network 2936. Detection of an unsafe condition indicative of a result of the neural stimulation results in cessation or modulation of the stimulation and delivery of a notification to the subject's healthcare provider.

Fig. 30A depicts a neurostimulation headset 3000. The neurostimulation headset 3000 can be used to implement at least some of the embodiments described herein. For example, the neurostimulation headset 3000 may be used to implement the wearable neurostimulation device 202 depicted in fig. 2A. The neurostimulation earphone 3000 includes an ear canal insert 3005, a concha insert 3010, a first electrical connector 3040 (not visible in fig. 30A, see fig. 30B), and a second electrical connector 3025. In some embodiments, the neurostimulation headset 3000 may include or may be configured to be coupled to a body portion of the audio headset 3050.

The ear canal insert 3005 may be adapted to fit into the ear canal of a human subject. The ear canal insert 3005 comprises a first electrode 3030 to electrically contact the skin within the subject's ear canal. The first electrical connector 3040 may connect the electrode 3030 of the ear canal insert to a first source of electrical current. The outer ear insert 3010 may be adapted to fit within the outer ear of a subject. The concha insert 3010 can comprise a base 3015 and a wing 3020, the base 3015 configured to fit within a cavity of a subject's concha, the wing 3020 configured to fit within a boat of the subject's concha. In some embodiments, outer ear insert 3010 can include a second electrode 3035 to electrically contact at least a portion of the subject's outer ear. Although electrode 3035 is shown on wing 3020 in the aspect depicted in fig. 30A, in other aspects, electrode 3035 may be located on base 3015 or on both base 3015 and wing 3020. A second electrical connector 3025 may connect the electrode 3035 of the concha insert to a second current source. In some embodiments, the first and second current sources may be a common current source.

In some embodiments, the nerve stimulation earpiece 3000 may include or otherwise be formed of a disposable material. For example, the electrode 3030 or the electrode 3035 may be a disposable electrode. In another example, a portion or all of the ear canal insert 3005 and/or the outer ear insert 3010 can be disposable. In some embodiments, wing portion 3020 of concha insert 3010 can comprise a soft, deformable, compliant, flexible, and/or elastic material. In some embodiments, wing 3020 of concha insert 3010 may comprise a rigid material. In some embodiments, outer ear insert 3010 can comprise a rigid material and a soft, deformable, compliant, flexible, and/or elastic material. In some embodiments, the base of the outer ear insert 3010 can comprise a hard material. In some embodiments, the base and wing portions 3020 of the concha insert may be integrally formed with each other. In some embodiments, one or more components of the neurostimulation headset 3000 can be constructed by a three-dimensional (3D) printer.

In some embodiments, at least a portion of the neurostimulation earphone 3000 (e.g., the outer ear insert 3010 and/or the ear canal insert 3005) can be formed for a particular subject. For example, at least a portion of the neurostimulation headset 3000 can be customized for a particular subject. In some embodiments, the neurostimulation headset 3000 can include a material that is initially flexible to mold the subject's ear and then retain its shape. For example, the material may be a plastic that is softened by heat, placed in the subject's outer ear and/or ear canal to mold the subject's ear. Once cooled, the plastic can retain its molded shape. In another example, the material may be an air-activated material that is initially flexible and hardens upon exposure to air. In some embodiments, an impression of the ear of the subject may be taken and a mold formed from the impression. A mold may be used to form the nerve stimulation earphone 3000. In some embodiments, a 3D scan may be taken of the subject's ear, and a mold may be generated from the 3D scan to form the neurostimulation headset 3000. In another embodiment, the neurostimulation headset 3000 can be constructed directly from a 3D scan (e.g., 3D printer, milling machine).

In some embodiments, the first electrode 3030 may have a thickness of between about 190mm²And about 380mm²The electrical contact area therebetween. In some embodiments, the second electrode 3035 can have a thickness of between about 100mm²And about 220mm²The electrical contact area therebetween. All or a portion of the electrical contact region of the first electrode 3030 and/or the second electrode 3035 can contact the skin of the subject. In some embodiments, the first electrode 3030 and/or the second electrode 3035 can include silver/silver chloride, platinum, tungsten, stainless steel, and/or gold components, conductive gels, hydrogels, conductive polymers, conductive foams, and/or fabrics. In some embodiments, the first electrode 3030 and/or the second electrode 3035 can include a layered structure that includes a hydrogel layer and a conductive polymer layer. In the example depicted in fig. 30A, second electrode 3035 includes a conductive polymer layer 3037 adjacent to a surface of wing portion 3020 of outer ear insert 3010 and a hydrogel layer 3036 adjacent to polymer layer 3037. When the neurostimulation headset 3000 is inserted into a subject's ear, at least a portion of the hydrogel layer 3036 can contact the skin of the subject's outer ear. In some embodiments, the first electrode 3030 and/or the second electrode 3035 can include two or more materials, e.g., a combination of two or more of the materials described herein.

Fig. 30B depicts an exploded view of the neurostimulation headset 3000 shown in fig. 30A. 30. In some embodiments, the ear canal insert 3005 can include a sound delivery portion 3045 adapted to deliver sound to the ear canal of a subject. In some embodiments, the sound delivery portion 3045 of the ear canal insert 3005 can include a passage through the ear canal insert to allow sound to pass from a speaker (not visible in fig. 30A-B) in the audio earpiece 3050, through the ear canal insert 3005, and into the ear canal of the subject. In some embodiments, the sound delivery portion 3045 can include a speaker in the audio headset 3050. In some embodiments, the neurostimulation headset 3000 may comprise a hearing aid and/or the neurostimulation headset 3000 may be included in a hearing aid. In some embodiments, the sound transmitting portion 3045 may be part of a hearing aid.

Fig. 31 depicts a block diagram of the neurostimulation headset 3000 shown in fig. 30A-30B. Although the audio earpiece 3050 including the speaker 3115 is illustrated as an assembly of the neurostimulation earpiece 3000 in fig. 31, in some embodiments, the audio earpiece 3050 may be a separate component operatively coupled to the neurostimulation earpiece 3000. As previously discussed with reference to fig. 30A, the first electrical connector 3040 may connect the electrode 3030 of the ear canal insert to the first current source 3105. A second electrical connector 3025 may connect the electrode 3035 of the concha insert 3010 to a second current source 3110. In some embodiments, the first current source 3105 and the second current source 3110 may be included in a separate device operably coupled to the neurostimulation headset 3000, as shown in fig. 31. In some embodiments, the first current source 3105 and the second current source 3110 may be included in the neurostimulation headset 3000. In some implementations, the first current source 3105 and the second current source 3110 are first and second terminals of a single current source 3101. In some embodiments, a single current source 3101 is located on the neurostimulation headset 3000. In some embodiments, a single current source 3101 is connected to the first electrical connector 3040 and the second electrical connector 3025 by a wired connection.

In some embodiments, the neurostimulation headset 3000 may include a wireless communication circuit 3120. The wireless communication circuit 3120 may be adapted to receive audio signals. The wireless communication circuit 3120 may transmit or receive data signals. The audio signal and/or the data signal may be transmitted and/or received from an audio device (e.g., a CD player, mp3 player) and/or a personal computing device (e.g., a tablet, a mobile phone, a smart watch, a laptop). In some embodimentsIn, the wireless communication circuit 3120 may include bluetoothA communication circuit.

In some embodiments, the neurostimulation headset 3000 can include the physiological sensor 3125. In some embodiments, the physiological sensor 3125 can be a separate device operably coupled to the neurostimulation headset 3000. The physiological sensor 3125 can receive and/or transmit a signal indicative of a physiological state of the subject. In some embodiments, the neural stimulation provided by the neural stimulation earpiece 3000 may be based, at least in part, on signals received and/or transmitted by the physiological sensor 3125. The physiological sensor 3125 may include at least one of an electroencephalogram (EEG) sensor, a heart rate sensor, a humidity sensor, a temperature sensor, a biological sensor, a chemical sensor, an Electrocardiograph (ECG), a motion sensor (e.g., an accelerometer and/or gyroscope), an Electromyography (EMG), a pulse oximeter, a current response sensor, or a photoplethysmograph probe. Other physiological sensors may also be used to implement the physiological sensor 3125. In some embodiments, the neurostimulation headset 3000 can include a plurality of physiological sensors 3125. In some embodiments, when the physiological sensor 3125 is implemented with a photoplethysmograph probe, the photoplethysmograph probe may include a 660nm red wavelength LED 3130 and a 940nm infrared wavelength LED 3135.

In some embodiments, the neurostimulation headset comprises an integrated audio headset for delivering an audio signal to the subject. In some embodiments, the nerve stimulation earpiece may include at least one mounting structure to physically mount the concha insert and/or the ear canal insert to a body structure of the audio earpiece. The audio headset may be a commercially available audio headset (e.g.,sport, Jaybird X2), and the mounting structure of the neurostimulation headset may be configured asTo mate with commercially available audio headphones. In some embodiments, the audio headset may be adapted to mate with a mounting structure of a nerve stimulation headset. Fig. 32A-34 depict exemplary configurations of mounting structures including nerve stimulation headphones and/or audio headphones.

Fig. 32A-32B depict a nerve stimulating earphone 3200 including an exemplary mounting structure. Fig. 32A depicts an audio earpiece 3250 and a neurostimulation earpiece 3200. A portion of a neurostimulation earpiece 3200 that can contact the ear of a subject can be seen in fig. 32A. Fig. 32B depicts a portion of a neurostimulation earpiece 3200 that may contact an audio earpiece 3250 in some embodiments. The nerve stimulation earpiece 3200 may include an ear canal insert 3205 and an outer ear insert 3210 having a base 3215 and wings 3220. In some embodiments, the mounting structure may include a recess 3225 in the base 3215 of the outer ear insert 3210. The recess 3225 may receive the protrusion 3230 of the main body structure of the audio headset 3250. In some embodiments, the mounting structure may include a coaxial recess 3235 within the ear canal insert 3205 to receive the protrusion 3240 of the body structure of the audio earphone 3250. In some embodiments, the recess 3235 may be formed on the interior of the ear canal insert 3205. The mounting structure may include a resilient conductive element that extends inwardly along at least a portion of the inner circumference of the recess 3225 and/or the recess 3235. In some embodiments, the mounting structure may form an electrical and/or mechanical connection between the nerve stimulation earphone 3200 and the audio earphone 3250. In some embodiments, one or more conductive elements of the mounting structure may be used to implement the first and/or second electrical connectors of the neurostimulation headset.

In some embodiments, the neurostimulation headset 3200 may include a wired connection 3255. In some embodiments, the audio headset 3250 may include a wired connection 3260. The wired connection 3255 and the wired connection 3260 may be held together by one or more clips 3265. The clip may prevent or reduce tangling of the wired connection 3255,3260. In some embodiments, the neurostimulation headset 3200 and/or the audio headset 3250 may include a wireless connection.

Fig. 33A-33B depict an exemplary neurostimulation headset 3300 including an exemplary mounting structure. Fig. 33A depicts an audio headset 3350 and a neurostimulation headset 3300. A portion of a neurostimulation headset 3300 that can contact the ear of a subject can be seen in fig. 33A. In some embodiments, fig. 33B depicts a portion of a neurostimulation headset 3300 that may be in contact with or interface with an audio headset 3350. The neurostimulation headset 3300 may include an ear canal insert 3305 and an outer ear insert 3310 having a base portion 3315 and a wing portion 3320. In some embodiments, the mounting structure may include at least one pin and/or socket 3325 on the base 3315 of the outer ear insert 3310 that may mate with a complementary socket and/or pin 3330 on the body structure of the audio headset 3350. The pins and/or sockets 3325 of the base 3315 on the concha insert 3310 may provide electrical and mechanical connection of the base 3315 of the concha insert 3310 to the body structure of the audio headset 3350. In some embodiments, the plug and/or socket elements of the mounting structure may be used to implement the first and/or second electrical connectors of the neurostimulation headset. In some embodiments, the base 3315 of the outer ear insert 3310 may include a protrusion 3335 that may be received by a recess 3340 on the body portion of the audio headset 3350.

Fig. 34 depicts a nerve stimulation earpiece 3400 including an exemplary mounting structure and an audio earpiece 3450. Neurostimulation earphone 3400 may include an ear canal insert 3405 and an outer ear insert 3410 having a base 3415 and wings 3420. In some embodiments, the mounting structure may include at least one clip and/or socket 3425 on base portion 3415 of outer ear insert 3410 that may mate with a complementary socket and/or clip 3430 on the body structure of audio headset 3450. A clip and/or socket 3425 on base portion 3415 of outer ear insert 3410 may provide both electrical and mechanical connection of base portion 3415 of outer ear insert 3410 to the body structure of audio headset 3450. In some embodiments, the mounting structure may include at least one clip element that may mate with a complementary clip element on the body structure of the audio headset. In some embodiments, the mounting structure may include a coaxial recess 3435 within the ear canal insert 3405 to receive a protrusion 3440 of the body structure of the audio headset 3450. In some embodiments, the recess 3435 can be formed in the interior of the ear canal insert 3405. The mounting structure may include a resilient conductive element that extends inwardly along at least a portion of the inner circumference of the recess 3435. The conductive element may snap into annular groove 3445 around the outer circumference of protrusion 3440 of the body structure of audio headset 3450 to make electrical contact with the circular conductive element in annular groove 3445 while making a mechanical connection with annular groove 3445. In some embodiments, the clip, socket, and/or annular groove elements of the mounting structure may be used to implement the first and/or second electrical connectors of the nerve stimulation earphone.

Fig. 35A depicts a neurostimulation earpiece 3500 and an audio earpiece 3550. In some embodiments, the audio headset 3550 may be a component of the neurostimulation headset 3500. The nerve stimulation earpiece 3500 may include an ear canal insert 3505 and an outer ear insert 3510 having a base 3515 and wings 3520. Fig. 35B depicts an exploded view of the nerve stimulation earpiece 3500 and the audio earpiece 3550.

Fig. 36 depicts a side view and a top plan view of a concha insert 3510. Fig. 37 depicts side and end views of the ear canal insert 3505. In some embodiments, the base 3515 of the concha insert 3510 can comprise a through hole 3525. The body structure of the audio earphone 3550 and/or the ear canal insert 3505 can include a protrusion 3530 (fig. 35B) configured to fit through the through-hole 3525 to mate with a complementary portion 3535 of the body structure of the other to secure the ear canal insert 3505 and the concha insert 3510 to the body structure of the audio earphone 3550. In other words, the canal insert 3505 and the audio earphone 3550 may engage with each other via the through hole 3525 of the concha insert 3510 to fix the canal insert 3505 and the concha insert 3510 to the audio earphone 3550. In the example shown in fig. 35A-37, the protrusion 3530 is included in the audio earpiece 3550 and the complementary portion 3535 is included in the ear canal insert 3505. In some aspects, protrusion 3530 and complementary portion 3535 mate via a threaded connection. In some embodiments, protrusion 3530 and complementary portion 3535 mate by a friction fit. In some embodiments, protrusion 3530 and complementary portion 3535 mate by a snap fit.

In some embodiments, through-hole 3525 has a non-circular shape, and at least a portion 3540 of protrusion 3530 has a non-circular shape that is complementary to the shape of through-hole 3525. When the protrusion 3530 is fitted into the through hole 3525, the outer ear insert 3510 can be prevented from rotating with respect to the main structure of the audio headset 3550. In some embodiments, the body structure of the concha insert 3510 and the audio headset 3550 may have other or additional complementary mating features that may prevent rotation of the concha insert 3510 relative to the body structure of the audio headset 3550.

In some embodiments, the outer ear insert 3510 has a first face 3511 that faces toward the subject's outer ear and a second face 3512 that faces away from the subject's outer ear and toward the body structure of the audio headset 3550. In some embodiments, base 3515 of concha insert 3510 and ear canal insert 3505 can include complementary mating features 3545,3555 that can allow concha insert 3510 to be assembled with the body structure of audio earphone 3550 with second face 3512 facing the body structure of audio earphone 3550, and can prevent concha insert 3510 from being assembled to the body of audio earphone with first face 3511 facing the body structure of audio earphone 3550. In some embodiments, the base 3515 of the concha insert 3510 and the body structure of the audio headset 3550 can include complementary mating features that can allow the concha insert 3510 to be assembled with the body structure of the audio headset with the second face 3512 facing the body structure of the audio headset 3550 and can prevent the concha insert 3510 from being assembled to the body of the audio headset 3550 with the first face 3511 facing the body structure of the audio headset 3550. In some embodiments, portion 3540 of protrusion 3530 and complementary mating feature 3545 can be complementary features.

Although fig. 32A-35B depict different embodiments of the neurostimulation headset, in some embodiments, the neurostimulation headset 3000 can be implemented using a combination of embodiments. For example, the annular recess 3445 of the nerve stimulation headset 3400 depicted in fig. 34 may be implemented in combination with the pin and socket structure of the nerve stimulation headset 3300 shown in fig. 33A. In some embodiments, the exemplary neurostimulation headset shown in fig. 32A-35B can be used to implement the neurostimulation headset 3000 shown in fig. 30A-30B.

Fig. 38 depicts a nerve stimulation earpiece 3800. In some embodiments, the neural stimulation earpiece 3800 may be used to implement the neural stimulation earpiece 3000. The nerve stimulation earpiece 3800 may include an ear canal insert 3805 and an outer ear insert 3810 having a base portion 3815 and a wing portion 3820. Shading of different portions of the concha insert 3810 depicts an example of a boundary between the base 3815 and the wing 3820. In some embodiments, the electrodes may be included on at least a portion of the base portion 3815, at least a portion of the wing portion 3820, and/or at least a portion of the base portion 3815 and the wing portion 3820. In some embodiments, the base portion 3815 and the wing portion 3820 may be implemented using different materials. In some embodiments, the base portion 3815 and the wing portion 3820 may be implemented using the same material.

Fig. 39A-39B depict a neural stimulation earpiece 3800 in a subject's ear 3900. Fig. 39A depicts an external side view of a neurostimulation earpiece 3800 and ear 3900. Fig. 39B depicts a cross-sectional view along the plane defined by line a-a. In some embodiments, the ear canal insert 3805 and the outer ear insert 3810 together are configured to fit within one of the subject's right or left ear and not the other of the subject's right or left ear. In some embodiments, the outer ear insert 3810 is shaped to fit within the outer ear of one of the subject's right or left ear and not the outer ear of the other of the subject's right or left ear. In other words, the ear canal insert 3805 and the outer ear insert 3810 together and/or the outer ear insert 3810 alone may be specifically designed to fit only within the left or right ear of the subject. In some applications, this may provide a more comfortable fit for the subject. In some applications, this may provide improved electrical contact with the outer ear of the subject.

Fig. 40 depicts a block diagram of an ear stimulation device controller 4000 that may be used to control any of the ear stimulation devices disclosed herein. Ear stimulation device controller 4000 may include a first analog output connector 4005, a second analog output connector 4010, a wireless microcontroller 4030, a digital stimulation signal generator 4020, a digital-to-analog converter (DAC)4025, a current driver 4015, and a power supply 4035. The first analog output connector 4005 can connect the first current signal to a first electrode 4042 of an ear stimulation device 4040 (e.g., the neurostimulation headset 3000 shown in fig. 30A). In some embodiments, the first electrode 4042 can be located on an ear canal insert of the ear stimulation device 4040. The second analog output connector 4010 can connect the second current signal to the second electrode 4044 of the ear stimulation device 4040. In some embodiments, the second electrode 4044 can be located on an outer ear insert of the ear stimulation device 4040.

Wireless microcontroller 4030 can control wireless communication between ear stimulation device controller 4000 and personal computing device 4045 to receive one or more stimulation parameters from personal computing device 4045. Exemplary personal computing devices include, but are not limited to, smart phones, cell phones, tablets, and mp3 players. The digital stimulation signal generator 4020 may generate a digital stimulation signal based, at least in part, on one or more stimulation parameters received from the personal computing device 4045. The DAC4025 may convert the digital stimulation signals from the digital stimulation signal generator 4020 into analog voltage waveforms. A current driver 4015 may be operably connected to the DAC4025 and generate a controlled current stimulation waveform in response to the analog voltage waveform. The controlled current stimulation waveform may be provided to the ear stimulation device 4040 via the first analog output connector 4005 and the second analog output connector 4010. A power supply 4035 may be operably connected to wireless microcontroller 4030, digital stimulation signal generator 4020, DAC4025, and/or current driver 4015.

In some embodiments, the wireless microcontroller 4030 may be a CC2650 microcontroller. An example of a wireless microcontroller that may be used to implement wireless microcontroller 4030 is a Texas Instruments (Texas Instruments) CC2650SimpleLink multi-standard ultra-low power wireless microcontroller unit for bluetooth communications. In some embodiments, the wireless microcontroller 4030 may be compatible with a JTAG standard debug interface. In some embodiments, wireless microcontroller 4030 may include a plurality of general purpose input/output pins. In some embodiments, wireless microcontroller 4030 may include a configurable serial peripheral interface. In some embodiments, wireless microcontroller 4030 may be a bluetooth controller.

In some embodiments, DAC4025 may include two or more output channels. One or more output channels may produce an inverted signal relative to another output channel. DAC4025 may be an 8-bit, 10-bit, 12-bit, 14-bit, or 16-bit DAC. Other bit value converters may also be used to implement DAC 4025. DAC4025 may be implemented as a single or multi-channel DAC. In some embodiments, DAC4025 may be implemented with DAC 7760. An example of a DAC that may be used to implement DAC4025 is a texas instruments DAC 776012 bit single channel programmable current/voltage output DAC. Another example of a DAC that may be used to implement DAC4025 is Texas instruments Dual, Low Power, Ultra-Low Glitch, Buffered Voltage output DAC 8163.

In some embodiments, ear stimulation device controller 4000 can include signal inverter 4021 to invert the analog voltage waveform output by DAC 4025. The inverted signal may be supplied to the current driver 4015 by the signal inverter 4021. In some embodiments, ear stimulation device controller 4000 may include signal inverter 4021 to invert the analog current waveform output by current driver 4015. The signal inverter 4021 may provide an inverted signal to the first analog output connector 4005 and the second analog output connector 4010.

In some embodiments, the current driver 4015 may generate a controlled current output that is not affected by load impedance. In some embodiments, current driver 4015 can be implemented as an XTR300 analog current/voltage output driver. An example of a current driver that can be used to implement current driver 4015 is the texas instruments XTR300 industrial analog current/voltage output driver. In some embodiments, the current driver 4015 can provide biphasic current stimulation. In some embodiments, the current driver 4015 can provide a current output between-100 mA and 100 mA. In some embodiments, the current driver 4015 can provide a current output between-20 mA and +20 mA. In some embodiments, the current output may be a maximum voltage of +/-40V. In some embodiments, the current output may be a maximum voltage of +/-10V. In some embodiments, current driver 4015 may receive a power input of +/-15V. In some embodiments, current driver 4015 may receive an input signal voltage of +/-VDD-3 and an external reference voltage. In some embodiments, the current driver 4015 may provide over-temperature, over-current, and common mode over-range error signals.

In some embodiments, the current driver 4015 may include an internal instrumentation amplifier 4016 to provide a copy of the stimulation current through set resistors via the IA channel. In some embodiments, the current driver 4015 may comprise an internal operational amplifier 4017 configured to provide 1/10 current copies. In some embodiments, the current driver 4015 can provide current to two or more stimulation channels that are electrically isolated from each other.

In some embodiments, the current driver 4015 may generate current pulses that fall within a safe range and/or comply with safety regulations (e.g., FDA regulations). The current driver 4015 may generate current pulses not exceeding 200Hz, 500Hz, 1kHz, or another maximum frequency. In some embodiments, the current driver 4015 can generate current pulses having a pulse duration of no greater than 2 ms. Current driver 4015 can generate current pulses having a voltage no greater than +/-12V. In some embodiments, current driver 4015 can generate current pulses having a voltage compliance no greater than +/-10V. In some embodiments, the current driver 4015 can generate current pulses having a maximum average current of no greater than 10 mA. In some embodiments, the current driver 4015 can generate a current pulse having a maximum primary depolarization phase duration of no greater than 500 ms. In some embodiments, the current driver 4015 can generate current pulses having a maximum direct current of no greater than 100mA during non-pulsing or device faults.

In some embodiments, power supply 4035 includes a battery 4036. Battery 4036 may be implemented as a 3.7V Li-polymer battery. Ear stimulation device controller 4000 may include a microUSB port 4037 connected to battery 4036. The microUSB port 4037 may be configured to connect the battery 4036 to an external power supply 4050 for recharging. In some embodiments, power supply 4035 may provide 3.3V. In some embodiments, the power supply 4035 may include a battery protection integrated circuit 4038. An example of a battery protection integrated circuit that may be used to implement battery protection integrated circuit 4038 is the texas instruments BQ2970 voltage and current protection integrated circuit. Another example of a battery protection integrated circuit that may be used to implement the battery protection integrated circuit 4038 is the Microchip MCP7383X lithium ion system Power Path Management Reference (Microchip MCP7383X Li-ion system Power Path Management Reference). Power supply 4035 may provide voltage and current protection in the event of erratic behavior, overcharging, or energy depletion in the battery. The power supply 4035 may automatically cut off current when overcharge, overdischarge, or a short circuit is detected. When the internal timer expires, the power supply 4035 may resume operation. In some embodiments, the ear stimulation device controller can include an internal timer 4039.

In some embodiments, the power source can include a connector 4041. In some embodiments, connector 4041 is a micro USB connector configured to connect to a power output of a mobile phone via a microUSB port. In some embodiments, connector 4041 is an audio jack connector configured to connect the power output of a mobile phone via a phone audio jack. In some embodiments, the power output of the mobile phone is provided by a battery included in the mobile phone.

In some embodiments, the personal computing device 4045 may be a mobile phone. The mobile phone may include a microUSB connection, an audio jack, and/or a wireless connection. In some embodiments, wireless microcontroller 4030 can communicate one or more data signals between ear stimulation device controller 4000 and the mobile phone via a microUSB connection. In some embodiments, wireless microcontroller 4030 can communicate one or more data signals between ear stimulation device controller 4000 and the mobile phone via a 2.4GHz bluetooth connection. Wireless microcontroller 4030 can communicate one or more data signals between ear stimulation device controller 4000 and the mobile phone via the phone's audio jack. Wireless microcontroller 4030 can communicate one or more data signals between ear stimulation device controller 4000 and the mobile phone via a wireless connection.

In some embodiments, the ear stimulation device controller 4000 can include a housing 4046, the housing 4046 including a recess 4047 for receiving a personal computing device. The recess may be configured to receive a mobile phone or tablet computer. In some embodiments, ear stimulation device controller 4000 can include an attachment means other than recess 4047 for attaching housing 4046 to a personal computing device. In some embodiments, the housing 4046 may be a cell phone housing that includes a recess 4047 to receive a cell phone. The ear stimulation device controller 4000 may include a microUSB connector 4048 to mate with a microUSB port of a cell phone.

In some embodiments, ear stimulation device controller 4000 can include a physiological signal input 4049 that can receive a physiological signal. The physiological signal input 4049 may receive a signal indicative of a physiological state of the user. In some embodiments, the output of the digital stimulation signal generator 4020 and/or the current driver 4015 may be based, at least in part, on the signal received by the physiological signal input 4049. The first and second output connectors 4005,4010 may be connected to an ear stimulating device 4040 located on a first ear of the user, and the physiological signal input may receive a physiological signal from a physiological sensor 4060 located on a second ear of the user.

Fig. 41 depicts a block diagram of a Printed Circuit Board (PCB)4100 of an ear stimulation device controller 4000. In some embodiments, ear stimulation device controller 4000 can include and/or be implemented as PCB 4100. In some embodiments, the PCB4100 may mount components on one or more sides. In some embodiments, the PCB may include a standard FR-4 substrate. PCB4100 may include a first signal layer 4105, a ground layer 4110, a power layer 4115, and a second signal layer 4120. In some embodiments, the PCB4100 may have components embedded in one or more layers. PCB4100 may include separate analog ground 4111 and digital ground 4112 regions, which may avoid or reduce the introduction of noise. The PCB4100 may include one or more de-noising capacitors 4125. The de-noising capacitor 4125 may be included in a separate layer and/or one or more layers of the PCB 4100. The PCB4100 may include an antenna 4130. The antenna 4130 may be included in a separate layer and/or one of multiple layers of the PCB 4100. The PCB may include one or more isolator chips 4135 located between the wireless microcontroller 4030 and the DAC 4025. The wireless microcontroller 4030 and DAC4025 may be located in the first signal layer 4105, the second signal layer 4120 and/or one may be located in the first signal layer 4105 and the other may be located in the second signal layer 4120. The one or more isolator chips 4135 may be located in the same layer of the PCB4100 and/or in a different layer of the PCB4100 than the wireless microcontroller 4030 and/or the DAC 4025. Exemplary isolator chips that may be used to implement the one or more isolator chips 4135 are texas instruments ISO7631FC 4kVpk low power three channel 25Mbps digital isolator and texas instruments ISO7310FC ECM low power single channel 1/0 digital isolator.

Fig. 42 depicts a block diagram of a neurostimulation system 4200 including a neurostimulation headset 4201 operatively coupled to an ear stimulation device controller 4202. Neurostimulation headset 4201 may include an ear canal insert 4205, an outer ear insert 4210, a first electrical connector 4240, and a second electrical connector 4240. In some embodiments, neurostimulation headset 4201 may include or may be configured to be coupled to an audio headset 4250, which audio headset 4250 may include a speaker 4215.

Ear canal insert 4205 may be adapted to fit into the ear canal of a human subject. Ear canal insert 4205 may include a first electrode 4230 to electrically contact the skin within the subject's ear canal. A first electrical connector 4240 may connect the electrodes 4230 of the ear canal insert 4205 to a first analog output connector 4255 of the ear stimulation device controller 4202. The outer ear insert 4210 may be adapted to fit within the outer ear of a subject. The outer ear insert 4210 may comprise: a base configured to fit within a cavity of an outer ear of a subject; and a wing configured to fit within a boat of an outer ear of a subject. In some embodiments, the outer ear insert 4210 can comprise a second electrode 4235 to electrically contact at least a portion of the outer ear of the subject. A second electrical connector 4225 may connect the electrodes 4235 of the concha insert to a second analog output connector 4260 of the ear stimulation device controller 4202.

In some embodiments, neurostimulation headset 4201 may include wireless communication circuitry 4220. The wireless communication circuit 4220 may be adapted to receive an audio signal. The wireless communication circuit 4220 may transmit or receive a data signal. Audio signals and/or data signals may be transmitted and/or received from an audio device (e.g., CD player, mp3 player), a personal computing device 4290 (e.g., tablet, mobile phone, smart watch, laptop), and/or an ear stimulation device controller 4202.

In some embodiments, neurostimulation headset 4201 may include physiological sensor 4245. In some embodiments, physiological sensor 4245 may be a separate device operably coupled to neurostimulation headset 4201. The physiological sensor 4245 may transmit and/or receive signals indicative of a physiological state of the subject. The physiological sensors 4245 may include at least one of an electroencephalogram (EEG) sensor, a heart rate sensor, a humidity sensor, a temperature sensor, a biological sensor, a chemical sensor, an Electrocardiograph (ECG), a motion sensor (e.g., an accelerometer and/or gyroscope), an Electromyography (EMG), a pulse oximeter, an amperometric response sensor, or a photoplethysmograph probe. Other physiological sensors may also be used to implement physiological sensor 4245. In some embodiments, neurostimulation headset 4201 may include a plurality of physiological sensors 4245. In some embodiments, the physiological sensor may be coupled to the physiological signal input 4295 of the ear stimulation device controller 4202. The physiological signal input 4295 may receive signals from physiological sensors 4245. In some embodiments, the output of the digital stimulation signal generator 4275 and/or the current driver 4265 of the ear stimulation device controller 4202 may be based, at least in part, on signals received from the physiological sensor 4245 through the physiological signal input 4295.

Ear stimulation device controller 4202 may include a first analog output connector 4255, a second analog output connector 4260, a wireless microcontroller 4280, a digital stimulation signal generator 4275, a digital-to-analog converter (DAC)4270, a current driver 4265, and a power supply 4285. First analog output connector 4255 may connect the first current signal to first electrode 4230 of neurostimulation headset 4201 via first electrical connector 4240. Second analog output connector 4260 may connect the second current signal to electrodes 4235 of neurostimulation headset 4201 via second electrical connector 4225.

Wireless microcontroller 4280 may control wireless communication between ear stimulation device controller 4202 and personal computing device 4290 to receive one or more stimulation parameters from personal computing device 4290. Exemplary personal computing devices include, but are not limited to, smart phones, cell phones, tablets, and mp3 players. The digital stimulation signal generator 4275 may generate a digital stimulation signal based, at least in part, on one or more stimulation parameters received from the personal computing device 4290. The DAC4270 may convert the digital stimulation signals from the digital stimulation signal generator 4275 to analog voltage waveforms. The current driver 4265 may be operably connected to the DAC4270 and generate a controlled current stimulation waveform in response to the analog voltage waveform. The controlled current stimulation waveform may be provided to neurostimulation headset 4201 via first analog output connector 4255 and second analog output connector 4260. The power supply 4285 may be operably connected to the wireless microcontroller 4280, the digital stimulation signal generator 4275, the DAC4270, and/or the current driver 4265.

In some embodiments, neurostimulation headset 4201 can be implemented with neurostimulation headset 3000. In some embodiments, ear stimulation device controller 4202 may be implemented with ear stimulation device controller 4000.

Fig. 43 is a flow chart of a method of controlling an ear stimulation device using a personal computing device. The ear stimulation device is a wearable neural stimulation device as described elsewhere herein (e.g., wearable ear stimulation device 202 controlled by personal computing device 208, as shown in fig. 2A and 2B) for delivering a stimulus to an ear of a user of the personal computing device to stimulate at least one nerve innervating the ear. In one aspect, an ear stimulation device includes a headset including a positioning element and a neural stimulator, various examples of which are described and depicted herein. In one aspect, the ear stimulation device is part of a system for delivering sound (e.g., music), and the headset includes a speaker or other sound source. In one aspect, the system includes a pair of headphones. In one aspect, only one earpiece includes a neurostimulator, but both earpieces include a speaker or other sound source. In another aspect, both of the headphones include a neural stimulator and a sound source. In another aspect, one earpiece includes a sound source and the other earpiece includes a neural stimulator. In one aspect, the method 4300 in fig. 43 comprises: capturing, using image capture circuitry on the personal computing device, an image of a user of the personal computing device via a user-facing camera associated with the personal computing device, as shown at 4302; processing the image using image processing circuitry on the personal computing device to determine at least one parameter, as shown at 4304; and controlling delivery of stimulation to at least one nerve innervating an ear of the user with the ear stimulation device, based at least in part on the at least one parameter, with a nerve stimulation control signal determination circuit on the personal computing device, as indicated at 4306.

44-46 depict other aspects of the method of FIG. 43, where steps 4302, 4304, and 4306 are as depicted and described in connection with FIG. 43. As depicted in fig. 44, in other aspects of the method 4400, the at least one parameter is indicative of at least one mood 4402 of the user, indicative of a physiological condition 4404 of the user, indicative of a medical condition 4406 of the user, indicative of identity information 4408 of the user, is a heart rate 4410 of the user, is related to an eye position 4412 of the user, is related to an eye movement 4414 of the user, or is indicative of a position 4416 of the headset relative to an ear of the user. Various schemes have been devised for identifying or classifying emotions, and the meaning of terms as used herein does not depend on any particular scheme. Examples of emotions include, but are not limited to, depression, anxiety, agitation, happiness, sadness, excitement, fear, and anger, for example. In various aspects, the physiological condition of the subject represents a medical condition of the subject. Medical conditions of a subject include, for example, muscle spasms, seizures, epilepsy (e.g., seizures, spasms, gaze), dozing, lethargy, fatigue, pain, fever, hypertension (e.g., sweating, flushing), hypotension, or a psychotic state.

Determining a parameter indicative of the position of the earpiece relative to the user's ear may include, for example, determining the distance of one or more portions of the earpiece relative to various anatomical features of the ear (e.g., ear canal, tragus, helix, earlobe, etc.) to determine, for example, whether the earpiece is positioned on an appropriate portion of the pinna or inserted far enough into the ear canal. In an aspect, the method 4400 further includes delivering a notification to the user under control of a notification circuit on the personal computing device informing the user that the position of the ear piece of the ear stimulation device relative to the user's ear needs to be adjusted, as indicated at 4418. In various aspects, delivering the notification includes delivering a text notification 4420, delivering a visible notification 4422, or delivering an audio notification 4424. The notification may be specific (e.g., a text or audio notification instructing the user to "push the earpiece further into the ear canal" or "move the earpiece up onto the pinna") or non-specific (e.g., a flashing light or beep indicating that the earpiece needs to be repositioned without providing detailed instructions regarding how it should be repositioned, in particular). In an aspect, delivering the notification includes delivering the directional notification 4426. As used herein, the term "directional notification" refers to a notification that provides information to the user regarding the direction of movement needed to move the headset into position. For example, in one aspect, the notification comprises a text or audio notification as described above that instructs the user to "push the earpiece further into the ear canal" or "move the earpiece up onto the pinna". In another aspect, the notification includes a tone that changes in tone as the headset is moved toward or away from position, or a click or other pulsing sound that repeats in frequency as the headset changes toward or away from position. In an aspect, the tone may change (i.e., change to another tone, or stop altogether) when the headset is in place.

Vagal innervation of the ear is not strictly symmetrical; for example, unlike the left ear, the right ear is dominated by branches of the vagus nerve, which, when stimulated, affect heart rate. Thus, in some cases, it may be preferable to stimulate the left ear instead of the right ear to avoid affecting the heart rate of the user. Thus, if the system includes two earphones (e.g., for delivering music or other audio to both the left and right ears), in one aspect, only one earphone includes a neurostimulator. For example, an earphone with a neurostimulator is then considered to be usable for the left ear, but not the right ear. In some aspects, the two earpieces are shaped differently such that one earpiece fits the left ear but not the right ear and the other fits the right ear but not the left ear. In other aspects, the two earpieces are shaped such that they fit into either ear. In this case, the two earphones may be distinguishable from each other based on shape or color, or by indicia included on the earphones or associated cables and the ear stimulation device control system. A method 4500, as another variation of the method of fig. 43 as outlined in fig. 45, may be used in conjunction with an ear stimulation device to ensure that an earphone with a neural stimulator is used only with ears that are deemed to be usable with it. The method 4500, at 4502, includes the steps of: processing the image using image processing circuitry to determine (at 4502a) the presence of at least one earpiece of an ear stimulation device located at an ear of the user, as shown at 4502 b; an ear of a user where the at least one earpiece is located, wherein the ear is selected from the right ear of the user and the left ear of the user, as shown at 4502c, and at least one attribute of the at least one earpiece that indicates availability of the at least one earpiece to one of the left or right ear of the user, as shown at 4502 d; determining, using application software on the personal computing device, that an ear of the headset may be used based on the at least one attribute of the at least one headset, as shown at 4502 e; determining, using application software on the personal computing device, whether the ear in which the at least one earpiece is located is an ear in which the earpiece can be used, as shown at 4502 f; and, if the ear in which the at least one earphone is located is not an ear in which the earphone is usable, sending a control signal from the personal computing device to the ear stimulation device under control of the neural stimulation control signal determination circuit to prevent the stimulation from being delivered through the earphone to the ear in which the earphone is located, as shown at 4502 g. In another aspect, method 4500 includes receiving, with a handshaking circuit on the personal computing device, a handshaking signal from an ear stimulation device control circuit associated with an ear stimulation device, as shown at 4504. This may include capturing an image of a user of the personal computing device in response to receiving a handshaking signal from the ear stimulation device control circuitry, as shown at 4506. In one aspect, method 4500 includes sending a handshake signal to an ear stimulation device control circuit, as shown at 4508, in response to determining that at least one earpiece is present that is located at an ear of a user in an image.

Fig. 46 depicts a method 4600, providing further details regarding the method of fig. 45, wherein the steps of fig. 46 are the same as steps 4502 in fig. 45. In one aspect, method 4600 includes, under control of a notification circuit on the personal computing device, communicating a notification to the user announcing that the user needs to switch the headset to the other ear, in the event that at least one headset is in an ear other than the ear in which the headset is available, as shown at 4602. Delivering the notification to the user may include, for example, one or more of: a text notification is transmitted at 4604, a visual notification is transmitted at 4606, or an audio notification is transmitted at 4608. In various aspects, determining 3433 at least one attribute of at least one earpiece includes: for example, the shape of the at least one earpiece is determined at 4610, or the color of the at least one earpiece is determined at 4612. In an aspect, determining the at least one attribute of the at least one earpiece 3433 includes determining the presence of a mark on the at least one earpiece or an accessory of the at least one earpiece, as shown at 4614. In one aspect, as shown at 4616, the accessory to the at least one headset includes a cable connected to the at least one headset.

Another approach to address the availability of neurostimulation of the right and left ears is to include stimulation electrodes in both earphones, but send a neurostimulation control signal to deliver the neurostimulation (e.g., the left ear) through only one of the earphones. In one aspect, the neural stimulation control signal is sent to only one earpiece. In one aspect, this is done if separate neurostimulation control signal outputs are provided for both headphones. On the other hand, the neural stimulation control signal is sent to both earphones, but the delivery of stimulation is caused by only one earphone. This may be accomplished, for example, by including ear stimulation circuitry in both earphones that generates neural stimulation in response to different neural stimulation control signals. For example, the neurostimulation control signal may have one or more characteristics (e.g., frequency, polarity, activation code) that cause activation of the ear stimulation device control circuitry in one of the two earpieces but not the other. It is assumed that it is known a priori that a particular earpiece (identified by the determined attribute in the user image) will receive and be activated by the neurostimulation control signal.

Fig. 47 is a block diagram of the ear stimulation device control system 4700. The system 4700 includes a personal computing device 4702, a user facing camera 4704 associated with the personal computing device, an image capture circuit 4706, an image processing circuit 4708, and a neural stimulation control signal determination circuit 4710. In various aspects, the personal computing device 4702 is, for example, a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer.

The image capture circuitry 4706 is adapted to capture an image 4712 of a user of the personal computing device 4702 from a user facing camera 4704. In one aspect, a user-facing camera is built into a personal computing device. In another aspect, the user facing camera 4704 is connected to the personal computing device via a wired or wireless connection. The image processing circuitry 4708 is configured to process the image 4712 using a parameter determination module 4714 to determine at least one parameter 4716. The neural stimulation control signal determination circuit 4710 is configured to control delivery of stimulation to at least one nerve innervating an ear of a user with the ear stimulation device 4732 based at least in part on at least one parameter 4716. In various aspects, the parameter 4716 represents one or more of at least one mood of the user, a physiological condition of the user, an identity of the user, or a heart rate of the user. In one aspect, the parameter 4716 is related to a user's eye position or eye movement. In one aspect, the parameter 4716 represents the position of the earpiece relative to the user's ear.

In an aspect, the image processing circuitry 4708 includes a headphone positioning module 4718 configured to process the image 4712 to determine the presence 4735 of at least one headphone 4719 of an ear stimulation device 4732 located at an ear of a user; an ear of a user in which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and at least one attribute 4733 of the at least one earpiece that represents the availability of the at least one earpiece 4719 to one of the user's left or right ear, as described above. For example, the attribute 4733 may be a flag 4721 that indicates that the headset in question includes a neurostimulator. In an aspect, the neural stimulation control signal determination circuitry 4710 is configured (with the earpiece position logic module 4720) to determine an ear that the earpiece may be used based on the at least one attribute 4733 of the at least one earpiece; determining whether an ear in which the at least one earphone is located is an ear in which the earphone can be used; and if the ear in which the at least one earpiece is located is not an ear to which the earpiece may be used, sending a control signal from the personal computing device to an ear stimulation device (the neurostimulation control signal 4722 from the neurostimulation control signal output 4724) to prevent the stimulation from being delivered to at least one nerve innervating the user's ear. As noted above, in some cases, it may be preferable to stimulate the left ear instead of the right ear, for example. Thus, in a system comprising two headsets, the two headsets may be distinguished from each other based on shape or color, or by including indicia on the headset or associated cable. In various aspects, the markers include any kind of markers detectable in the image by image processing. The indicia may comprise solid color or pattern indicia on the headset or may comprise features of the headset itself (e.g., the color of the material from which the headset is made). The label may be detectable in the visible spectrum or at other wavelengths. In some aspects, the indicia may comprise text, alphanumeric indicia, or symbols. The right and left ears of the user may be identified in the user image 4712 using image processing methods, such as m.m. fakhir et al, "Face Recognition Based on sources Measurement Technique," 2014UKSim-AMSS8th European modeling Symposium, pp.158-162; U.S. patent application publication nos. 2016/0026781 to Boczek et al; and Holm, U.S. patent application publication No. 2008/0285813; each of which is incorporated herein by reference. In some aspects, the position of one or both ears relative to the face is determined; in some aspects, the shape and/or characteristics of one or both ears are determined.

In one aspect, ear stimulation device control system 4700 includes a handshaking circuit 4726 that is adapted to receive a handshaking signal 4728 from ear stimulation device control circuit 4730 associated with ear stimulation device 4732. In one aspect, image capture circuitry 4706 is adapted to capture an image 4712 of a user of personal computing device 4702 in response to receiving handshake signals 4728 from ear stimulation device control circuitry 4730. For example, in one aspect, after the user image 4712 has been captured and evaluated by the image processing circuitry 4708, an exchange of information between the ear stimulation device control system 4700 and the ear stimulation device 4732 is initiated, and it has been determined by the ear speaker position logic module 4720 that an ear speaker containing an ear stimulation device has been placed on the appropriate ear of the user. Alternatively, if two headsets are used that include ear stimulating devices, the handshaking signal from each headset may include a headset identification code that identifies the headset. For example, the headset identification code and the indicia associated with a particular headset may be linked in a look-up table stored in the data storage circuitry 4764.

In an aspect, the neurostimulation control signal determination circuit 4710 is configured for sending a handshaking signal 4734 to the ear stimulation device control circuit 4730 in response to determining the presence 4735 of at least one earpiece positioned at an ear of a user in an image.

In one aspect, the ear stimulation device control system comprises an output device 4740 and a notification circuit 4742 adapted to provide a notification through the output device 4740 instructing a user to switch the ear piece to the other ear if at least one ear is not an ear for which the ear piece is usable. For example, the output device 4740 may be part of the user interface 4744. In an aspect, the output device is adapted to transmit a textual notification 4746 to the user (e.g., the output device includes an LED or LCD display, a 7-segment display, or other alphanumeric display). In another aspect, the output device 4740 is adapted to deliver a visual notification 4748 to the user, which may include a textual display as previously described, a graphic or symbol presented on a display, or a light that may be illuminated, flashed, etc., to attract the user's attention. In an aspect, the output device 4740 is adapted to deliver an audio notification 4750 to the user (e.g., the output device 4740 includes a speaker, a ringtone, a buzzer, or other audio source for delivering one or both of an oral notification or an alarm sound). The user interface 4744 may also include one or more user inputs 4752 of various types, e.g., as described elsewhere herein.

As described above, the image processing circuitry 4708 includes the earpiece position module 4718 configured to process the image 4712 to determine at least one attribute 4733 of at least one earpiece, wherein in an aspect, the at least one attribute 4733 represents the availability of the at least one earpiece for one of a left ear or a right ear of the user. Additionally, the neural stimulation control signal determination circuitry 4710 is configured (with the earpiece position logic module 4720) to determine an ear that the earpiece may be used with based on at least one attribute of at least one earpiece. In an aspect, the at least one attribute of the at least one earpiece includes a shape of the at least one earpiece, a color of the at least one earpiece, a presence of a marking 4721 on the at least one earpiece, or a presence of a marking 4721 on an accessory of the at least one earpiece, wherein the accessory of the at least one earpiece may be, for example, a cable connected to the at least one earpiece, as described above. For example, in a system where only one of the two earphones includes a stimulating electrode, the cable connected to the earphone with the electrode may include a light and dark striped pattern, while the cable connected to the other earphone may be a single color. In embodiments using two earpieces including ear stimulation devices, the neural stimulation control signal determination logic may send the neural stimulation control signal 4722 based on the output earpiece position logic module 4720 sufficient to only activate the earpiece that may be used with the ear in which it is located.

In one aspect, image processing circuitry 4708 includes emotion determination module 4754 that determines the emotion of a user from user image 4712 based on, for example, one or more parameters 4716, e.g., using methods described in: su, "Assimple approach to facial expression recognition," Proceedings of the 2007Int' l Conf on Computer Engineering and Applications, Queenland, Australia,2007, pp.456-461; U.S. patent nos. 9,036,018 to Wang et al; U.S. patent 8,488,023 to Bacivarov et al, and U.S. patent application publication 2004/0207720 to Miyahara et al, each of which is incorporated herein by reference.

In an aspect, the image processing circuitry 4708 includes a physiological condition module 4756 that determines a physiological condition of a user from the user images 4712 based on one or more parameters 4716. The physiological condition of the user can be moved from the eyes,Pupil dilation, heart rate, respiration rate, facial coloration, facial temperature, etc. Visible or IR images of the patient obtained with a camera built into or operatively connected to the personal computing device may be used. Still or moving (video) images may be used. For example, euler video amplification may be used to analyze video images of a subject to determine blood flow. Further data analysis may be used to determine the blood pressure of the subject. See, e.g., Wu et al, ACM trans. graph.31,4, Article 65, July 2012; (can be selected fromhttp://doi.acm.org/10.1145/2185520.2185561Obtained online), which is incorporated herein by reference. An infrared camera may be used to measure corneal temperature (see, e.g., Kessel et al, investigative opthalmology and Visual Science 51: 6593-. An infrared camera with a focal plane array detector, thermal sensitivity ≦ 0.09 deg.C, and accuracy of 0.1 deg.C is available from Fluke Corp, Everett, WA (see, e.g., the Fluke _ Ti25 data sheet, which is incorporated herein by reference).

Peripheral sympathetic Responses can be detected by image analysis, as described in IEEE TRANSACTIONS BIOMEDICAL ENGINEERING, VOL.56, NO.2, FEBRUARY 2009477, Imaging Facial Signs of neurophysiological Responses, Dvijesh Shastri, Association Member, IEEE, ArangeloMerla, Member, IEEE, Panagiotis Tsiamyrtzis, and Ioanis Pavlidis, Senior Member, IEEE, which is incorporated herein by reference. For example, thermographic measurements from several different regions of the face provide an indication of blood flow, sweat gland activation, and respiration, providing information similar to galvanic skin response. In aspects, physiological condition module 4756 is used to determine one or more medical conditions including, for example, muscle spasms, seizures, epilepsy (e.g., seizures, spasms, gaze), dozing, lethargy, fatigue, pain, fever, hypertension (e.g., sweating, flushing), hypotension, mental state.

In an aspect, the image processing circuitry 4708 includes an identity determination module 4758 that determines the identity of a user from a user image 4712 based on one or more parameters 4716. For example, systems and algorithms are described that obtain iris images, identify unique features, and quickly compare key features of the iris images to a large database of iris images (see, e.g., U.S. patent No.5,572,596 to Wildes et al, 11/5/1996 and U.S. patent No.4,641,349 to Flom et al, 2/3/1987, which are incorporated herein by reference). An Iris scanning system including a near infrared (about 700-. In another aspect, a facial recognition circuit is used to determine the presence of a user through facial recognition, for example, using the methods described in the following documents: wheeler, Frederick w.; weiss, r.l.; and Tu, Peter H., "Face Recognition at a Distance System for Surveillance Applications," fourth IEEE International reference on Biometrics: the same and Systems (BTAS),2010Page(s):1-8(DOI:10.1109/BTAS. 2010.56564523), and Moi Hoon Yap; ugail, h.; zwigelaar, r.; rajoub, b.; doherty, v.; appleyard, s.; and Hurdy, G., "A Short review of Methods for Face Detection and Multi fractional Analysis," International conference on cyberwolds, 2009.CW'09., Page(s): 231-. Biometric identification may also include identification based on various physiological or behavioral characteristics, such as fingerprints, voice, iris, retina, hand geometry, handwriting, keystroke patterns, and the like, for example, as described in Kataria, a.n.; adhyalu, d.m.; sharma, a.k.; and Zaveri, T.H. "A Survey of automated biological Automation Techniques" Nirma University International Conference on Engineering (NUiCONE),2013, Page(s):1-6(DOI:10.1109/NUiCONE.2013.6780190), which is incorporated herein by reference. Us patent 8,229,178 to Zhang et al, 7/24/2012, which is incorporated herein by reference, describes a method for acquiring an image of the palm veins with visible and infrared light and extracting features from the image to identify the identity of an individual. Biometric identification may be based on imaging of the retina or iris, as described in U.S. patent No.5,572,596 to willes et al, 11/5/1996, and U.S. patent No.4,641,349 to Flom et al, 2/3/1987, each of which is incorporated herein by reference. A combination of several types of identity signals may also be used (e.g., voice and video, as described in Aleksic, P.S. and Katsaggalogos, A.K. "Audio-visual biometrics," Proceedings of the IEEE Volume:94, Issue:11, Page(s): 2025-.

In an aspect, the image processing circuitry 4708 includes an eye tracking module 4760 that determines eye position or eye movement from the user image 4712 based on one or more parameters 4716. For example, gaze tracking systems for monitoring eye position are available from Seeing Machines Inc., Tucson, AZ (see, e.g., Specification Table: "faceLAB^TM5 specificities ", incorporated herein by reference). Eye position, eye rotation, eye gaze position to the screen, pupil diameter, and eye vergence distance may be monitored. Eye rotation measurements of +/-45 degrees about the y-axis and +/-22 degrees about the x-axis are possible. A typical static accuracy of gaze direction measurement is 0.5-1 degree rotation error. The eye position may be sensed using the methods and systems described in U.S. patent 8,808,195 to Tseng et al, which is incorporated herein by reference, or may be sensed by other methods described herein or known to those skilled in the relevant arts. The eye position may include a static or fixed eye position/gaze direction or a dynamic eye position/eye movement. In one aspect, the eye tracking module 4760 detects pupil diameter. Pupil diameter may be measured, for example, by the method described in us patent 6,162,186 to Scinto et al, which is incorporated herein by reference.

The ear stimulation device control system 4700 may include various other components as generally described elsewhere herein, including, but not limited to, for example, a communication circuit 4762, a data storage circuit 4764, and a reporting circuit 4766. Similarly, the ear stimulation device 4732 may include additional components including, but not limited to, a communication circuit 4768 and a stimulator driver circuit 4770. Additionally, ear stimulation device 4732 can include fixation member 4772 or be used in conjunction with fixation member 4772. In an aspect, the fixation member comprises or is part of an earpiece.

Fig. 48A and 48B illustrate examples of user interfaces used in connection with an ear stimulation device control system implemented on a personal computing device, and in particular, the manner in which an ear stimulation device is controlled using processing of user images captured by a user-facing camera. In the example of fig. 48A, the personal computing device is a smartphone 4800 configured with application software that notifies the user of incorrect placement of the headset. Detection and notification is performed, for example, as described in connection with fig. 43-47. The delivery of text, visual, and audio notifications to a user is shown in FIG. 48A (e.g., as in the method of FIG. 46). In the system shown in fig. 48A and 48B, the ear stimulation device itself is not shown, but it would be connected to a smartphone 4800, for example, through an audio jack to smartphone 4800. The touch screen 4802 of the smartphone 4800 serves as a user interface (e.g., the user interface 4744 in fig. 47). A user image 4804 captured with a user-facing camera 4806 is displayed on the touch screen 4802. Image analysis of the user image 4804 is performed by image processing circuitry (e.g., image processing circuitry 4708 in fig. 47) to determine whether the headset including the ear stimulation device is positioned correctly. In one aspect, proper positioning of the ear stimulation device means that the earpiece is positioned on the correct ear, and in some cases also means that the earpiece is positioned in the proper position on the ear. In the example of fig. 48A, the headphones 4808 and 4810 in the user image 4804 are different colors, thereby enabling the two headphones to be distinguished. Alert symbol 4812 (exclamation point in circle) informs the user of an alert message, which is delivered through alert text 4814 displayed on touch screen 4802. In this case, the alert text 4814 provides an alert message "1, warning: stimulus blocked! The stimulation headphones are switched to the other ear to allow the stimulator to activate. (1.ALERT: STIMULATION BLOCKED! Switch simulation appearance to other ear simulation simulator activation.) the "X '4816 (or other marker) displayed next to the user's image 4804 indicates to the user that the headphones 4808 and 4810 are not properly positioned. An audible notification 4822 (e.g., a "beep") conveyed by the speaker 4820 is also provided to draw the user's attention to the incorrectly positioned earphone. A second user image 4824, which serves as an example to depict a properly placed earpiece, is also presented on the touch screen 4802. The color of the headphones in image 4824 can be enhanced or highlighted in the image to emphasize the importance of placing a particular color of headphones at a particular ear. A checkmark 4826 (or other marking) is used to indicate that the second user image 4824 depicts the correct headset position. The checkmark 4826 may be animated, for example, to switch from blinking to solid or to change color from red to green when the user switches the headset to the correct position. Once the ear piece is properly positioned, an ear stimulation device control system implemented with a smart phone 4800 controls the ear stimulation device to deliver stimulation to the subject's ear, as described elsewhere herein.

As described in connection with fig. 47, in one aspect, the ear stimulation device control system 4700 includes an emotion determination module 4754, a physiological condition module 4756, an identity determination module 4758, and an eye tracking module 4760. These modules may be used to determine additional information about the user on which the base controls the ear stimulation device. In fig. 48B, a touch screen 4802 of a smartphone 4800 is used as a user interface. A user image 4804 captured with a user-facing camera 4806 is displayed on the touch screen 4802. Image analysis of the user images 4804 is performed by the image processing circuitry 4708, as shown in fig. 47, to determine the identity of the user, and possibly also the emotional and physiological state of the user. After the identity of the user is determined, the neural stimulation may be determined using the user-specific information. For example, stimulation level settings that have been optimized for the user may be retrieved from memory and used to configure the ear stimulation device. In addition, the stimulation delivered with the stimulation device may be adjusted according to the emotional or physiological state of the user.

Additionally, in an aspect, application software on smartphone 4800 prompts the user to enter additional information regarding emotions or other parameters, similar to application software 2908 described in connection with FIG. 42. in the example of FIG. 48B, it may not be easy to determine the mood of the subject from the user's relatively neutral expression in image 4804.

As described above, in one aspect, image detection and analysis is used to detect incorrect placement of one or more headsets on the ears of a user of a personal computing device. In some aspects, it is desirable to detect the quality of electrical contact between the ear and electrodes used to deliver electrical stimulation to the ear or sense electrical signals from the ear. Fig. 49 is a block diagram depicting a neurostimulation system 4900, which neurostimulation system 4900 includes an ear stimulation device 4902 and an ear stimulation device control system 4904. Fig. 49 depicts further aspects of a neurostimulation system 4900 including an ear stimulation device control system 4904, the ear stimulation device control system 4904 for controlling an ear stimulation device 4902 that delivers electrical stimulation via one or more electrodes 4906 and 4908. Ear stimulation device control system 4904 determines whether one or more electrodes 4906 and 4908 are in good electrical contact with the user's ear and informs the user of the status of electrodes 4906 and 4908 for adjustment as needed. In addition, if it is determined that there is no good electrical contact between the electrodes and the ear, delivery of the stimulus via the electrodes may be prevented. Ear stimulation device control system 4904 includes a personal computing device 4910, personal computing device 4910 configured to control delivery of stimulation by ear stimulation device 4902 to at least one nerve innervating an ear of a user of personal computing device 4910. Ear stimulation device 4902 includes at least one first electrode 4906. The personal computing device 4910 includes an electrical signal input circuit 4912 adapted to receive an electrical signal 4914 representative of electrical contact of the at least one first electrode 4906 with an ear of a user of the personal computing device 4910. Personal computing device 4910 includes a contact determination circuit 4916 configured to determine whether the at least one first electrode 4906 is in good electrical contact with the user's ear, and a neurostimulation control signal determination circuit 4920 configured to transmit a neurostimulation control signal 4922 from personal computing device 4910 to ear stimulation device 4902 to prevent delivery of stimulation if the at least one first electrode 4906 is not in good electrical contact with the user's ear. Additionally, the personal computing device 4910 includes a notification circuit 4922 configured to communicate a notification to a user regarding a status of the at least one first electrode 4906. The personal computing device 4910 may be, for example, a phone, a watch, a wearable device, a tablet, a laptop, or a desktop computer.

In one aspect, ear stimulation device control system 4904 includes a handshaking circuit 4924 that is adapted to receive a handshaking signal 4926 from an ear stimulation device control circuit 4928 associated with ear stimulation device 4902. In an aspect, ear stimulation device control system 4904 includes a test signal circuit 4930 configured to deliver an electrical test signal 4932 via at least one second electrode 4908 of at least one ear stimulation device 4902 and to detect an electrical signal 4914 via at least one first electrode 4906 in response to electrical test signal 4932. In an aspect, the contact determination circuit 4916 is configured to determine an electrical impedance between the at least one first electrode 4906 and the at least one second electrode 4908. In an aspect, the contact determination circuit 4916 is configured to determine a magnitude of the electrical signal 4914. In an aspect, the contact determination circuit 4916 is configured to determine a signal-to-noise ratio of the electrical signal 4914. In an aspect, the contact determination circuit 4916 is configured to determine a phase shift or frequency content of the electrical signal 4914. In various aspects, the contact determination circuit 4916 includes an amplitude determination module 4934 for determining the amplitude of the electrical signal 4914, a signal-to-noise ratio determination module 4936 for determining the signal-to-noise ratio of the electrical signal 4914, or a phase shift/frequency content determination module 4938 for determining the phase shift or frequency content of the electrical signal 4914.

In one aspect, ear stimulation device 4902 includes an earpiece 4940, earpiece 4940 including at least one first electrode 4906. In an aspect, the notification circuit 4922 is configured to instruct the user to reposition the earpiece 4940, replace at least a portion of the at least one first electrode 4906, clean at least a portion of the at least one first electrode 4906, wet at least a portion of the at least one first electrode 4906, or apply a gel to at least a portion of the at least one first electrode 4906. As discussed above, in various aspects, ear stimulation device 4902 includes or is used in conjunction with a fixation member 4942, and may include additional circuit components as described elsewhere herein, e.g., a communication circuit 4944 and a stimulator driver circuit 4946. In an aspect, the notification circuit 4922 is configured to deliver one or more of a text notification, a visual notification, or an audio notification. The neurostimulation system 4900 of the various aspects includes other components as described elsewhere herein. For example, in various aspects, the personal computing device 4910 includes a user interface 1214 including a user input device 1362 and a user output 1364 including an audio output 1366, a graphical display 1368, an alphanumeric display 1392, or a touchscreen 1394, e.g., as described in fig. 13 and in connection with fig. 13. In various aspects, the ear stimulation device control system includes a neural stimulation control signal output 4724, a communication circuit 4762, and a data storage circuit 4764, as described in connection with fig. 47. In various aspects, the neurostimulation system 4900 includes one or more sensors 4950, which may include neural signal sensors of various types, such as described in connection with the neural signal sensor 702 or the auxiliary sensor 750 in fig. 7, other physiological sensors, environmental sensors, motion sensors, location sensors, for example. In some aspects, neurostimulation system 4900 includes an auxiliary stimulator 818, e.g., as described in connection with fig. 7. In some aspects, the neurostimulation system 4900 includes an acoustic source 856, e.g., as described in connection with fig. 7. The notification circuitry 4742 and the reporting circuitry 4766 are as described in connection with fig. 7. The personal computing device 4910 is configured with application software 4950 that includes, but is not limited to, the various modules described in detail herein.

Fig. 50 depicts a method of controlling an ear stimulation device with a personal computing device in response to detecting contact between an electrode and a user's ear, as described in connection with fig. 49. As described above, the personal computing device may be, for example, a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer. Method 5000 includes detecting, at an electrical signal input circuit via at least one first electrode of an earpiece of an ear stimulation device, an electrical signal representative of electrical contact of the at least one first electrode with an ear of a user of a personal computing device, wherein the at least one earpiece is operatively connected to the personal computing device, and wherein the ear stimulation device is adapted to stimulate at least one nerve innervating the ear of the user of the personal computing device, as shown at 5002; determining, using contact determination circuitry on the personal computing device, whether the at least one first electrode is in good electrical contact with the user's ear, as shown at 5004; if the at least one first electrode is not in good electrical contact with the user's ear, sending a control signal from the personal computing device to the ear stimulation device under control of the neurostimulation control signal determination circuitry on the personal computing device to prevent the delivery of the stimulation through the headset to the ear in which the headset is located, as shown at 5006; and transmitting a notification to the user regarding the state of the at least one first electrode under control of a notification circuit on the personal computing device, as shown at 5008.

Determining whether the at least one first electrode is in good electrical contact with the user's ear may be performed by various methods, as discussed below. Good electrical contact may be defined by setting a threshold for one or more measured parameters, such that contact is defined as "good" if the measured parameter is equal to or above the threshold and "bad" if below the threshold parameter. In an aspect, determining whether the at least one first electrode is in good electrical contact includes providing a level of contact quality, such as "strong", "medium", "usable but weak", "unusable", where any usable contact quality is considered "good", but unusable contact is considered "bad".

Other aspects and variations of method 5000 are shown in fig. 51-52. In these figures, steps 5002, 5004, 5006 and 5008 are the same as in figure 50.

Fig. 51 depicts a method 5100 that further details the method of fig. 50. Steps 5002, 5004, 5006 and 5008 are as described in connection with figure 50. In one aspect, method 5100 includes receiving, at a handshaking circuit on the personal computing device, a handshaking signal from an ear stimulation device control circuit associated with an ear stimulation device, as shown at 5102. In another aspect, method 5100 includes delivering an electrical test signal through at least one second electrode of at least one headset under control of a test signal circuit on the personal computing device, and detecting an electrical signal through at least one first electrode in response to the electrical test signal, as shown at 5104. This may include, for example, determining an electrical impedance between the at least one first electrode and the at least one second electrode, as shown at 5106. In aspects, determining whether the at least one first electrode is in good electrical contact with the user's ear (at 5004) includes determining the amplitude of the electrical signal, as shown at 5108, determining the noise ratio of the electrical signal, as shown at 5110, or determining the phase shift or frequency content of the electrical signal, as shown at 5112.

Fig. 52 depicts a method 5200 that includes a further variation of the method shown in fig. 50 that involves communicating a notification to a user regarding a status of at least one first electrode. In various aspects, delivering the notification to the user includes instructing the user to reposition the earpiece, as shown at 5202, instructing the user to replace at least a portion of the at least one first electrode, as shown at 5204, instructing the user to clean at least a portion of the at least one first electrode, as shown at 5206, instructing the user to wet at least a portion of the at least one first electrode, as shown at 5208, or instructing the user to apply a gel to a portion of the at least one first electrode, as shown at 5210. In other aspects, communicating the notification to the user includes communicating a text notification, as shown at 5212, communicating a visual notification, as shown at 5214, communicating an audio notification, as shown at 5216, or communicating a directional notification, as shown at 5218. For example, a notification may be delivered as described in connection with FIG. 44 or as shown in FIG. 48A. In another aspect, method 5200 includes delivering an audio test signal via a sound source associated with at least one earpiece under control of test signal circuitry on the personal computing device and determining a correct placement of the at least one earpiece based on the audio feedback, as shown in fig. 5220. In one aspect, the audio feedback is determined from the audio signal detected from the earpiece, which will vary depending on the placement of the earpiece, e.g., whether it is securely fixed within the ear canal. In an aspect, the audio feedback is determined from a user, e.g., the user self-reports audio quality.

Fig. 53 illustrates a neurostimulation system 5300 including an ear stimulation device 5302 and a personal computing device 5304, which is configured for monitoring a personal computing device application 5306 for use by a user of the neurostimulation system 5300. As other examples presented herein, the personal computing device 5304 may be, for example, a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer. Aspects of the neurostimulation system 5300 that are not described in detail in connection with fig. 53 are generally described in connection with the other embodiments depicted and described herein.

Personal computing device application 5306 includes audio delivery module 5310, emotion assessment module 5312, cofactor input module 5314, user control module 5316, stimulator control module 5318, and controller interface module 5320. The various modules include application software that operates in relation to the personal computing device hardware and software (i.e., the personal computing device hardware is configured by the application software) to provide the functionality of the modules. The personal computing device 5306 includes other hardware and software components as described elsewhere herein as well as conventional hardware and software components not specifically described herein. The term "module" as used herein refers to application software operating on the personal computing device hardware and used to configure the personal computing device hardware to provide the device's specialized circuit functions. Generally, a module utilizes, and in one aspect can be considered to contain, data storage circuitry and processing circuitry of a personal computing device.

Audio delivery module 5310 is adapted to control the delivery of audio signals from audio signal source 5322 via audio output 5326 of personal computing device 5304 to audio headphones 5324, audio headphones 5324 having ear stimulation device 5302 associated therewith configured to stimulate nerves innervating a user's ear. The audio signal source 5322 may be, for example, an audio player application 5324, a network radio application 5326, a radio receiver 5328, a telephone receiver 5330, or a hearing aid 5331.

The emotion assessment module 5312 is adapted to receive emotion-related input from the user via a first input structure 5332 associated with the personal computing device and assess the emotion of the user based at least in part on the emotion-related input. In one aspect, emotion assessment module 5312 includes an ecological transient assessment module 5334. The Ecological transient Assessment module 5334 comprises application software on a personal computing device that gathers information from a user about the user's behavior and experience by querying the user at intervals during the day they conduct daily activities in a "natural environment" (e.g., described in terms of the user's self-reporting mood at recall during a clinic visit), for example as described in Shiffman et al, "Ecological mental Assessment," annual review of Clinical mental, Vol.4:1-32, April 2008 (first online on day 28, 11 month 2007), DOI: 10.1146/annual. In some aspects, emotion assessment module 5312 includes an activity assessment module 5335 that tracks and analyzes user activity related to the usage of the personal computing device (e.g., using social media, web searches, voice patterns, typing patterns, including number and/or type of usage) to determine the user's emotion. For example, in one aspect, the activity assessment module 5335 analyzes typing patterns using techniques such as those described in U.S. patent 6,231,344 to Merzenich et al, U.S. published patent application 2005/0084832 to Janssen et al, each of which is incorporated herein by reference. In one aspect, the activity assessment module 5335 determines when the patient enters the instruction. In one aspect, the specific instructions entered by the patient need not be determined, but rather only the frequency with which the patient uses the personal computing device, and/or the speed at which the patient enters the instructions into the personal computing device. In other aspects, specific instructions may be detected, for example, to determine whether the patient chooses to listen to music, play games, send or read email, answer a phone call, or place a phone call. Sensing and processing game controller signals (e.g., to determine reaction times) can be substantially as described in Brown's U.S. patent 5,913,310 or Brown's U.S. patent 6,186,145, both of which are incorporated herein by reference. It should be understood that while Brown describes a video game designed primarily for educational purposes related to healthcare, the video game may be used for entertainment purposes and need not include educational or medical components. In an aspect, the activity assessment module 5335 is configured to process the audio signal (e.g., detected from a cell phone) to determine the patient's speech pattern. In an aspect, the emotion assessment module 5312 includes an image processing module 5336 adapted to determine the emotion of the user based on image analysis of the user's image detected with the user facing camera 5338 of the personal computing device 5304, e.g., as discussed above. In various aspects, mood assessment module 5312 is adapted to receive mood-related input related to, for example, depression, stress, or emotion. The first input structure 5332 of the personal computing device in various aspects includes a touchscreen 5340, a keyboard, or a microphone.

The cofactor input module 5314 is adapted to receive at least one input related to at least one cofactor related to a user via the second input structure 5350 associated with the personal computing device 5304. The auxiliary input structures 5350 of the personal computing device 5304 include at least one of a touch screen 5340, a keyboard 5342, a microphone 5344, a device interface 5352, a data input 5354, a USB port 5356, a wireless interface 5358, a serial port 5360, and a parallel port 5362. Touch screen 5340, keyboard 5342, microphone 5344 are examples of components of user interface 5364, but it will be understood that input may be received by other types of user interface devices, as known to those skilled in the art. Data input 5354, USB port 5356, wireless interface 5358, serial port 5360, and parallel port 5362 are examples of device interface 5352; other device interfaces may also be used. In some aspects, the first input structure 5332, the second input structure 5350, and the third input structure 5366 can be the same type of input structure, and in fact can be the same input structure. In other aspects, one or more of the first input structure 5332, the second input structure 5350, and the third input structure 5366 are the same type of input structure, but different input structures. In some aspects, the first input structure 5332, the second input structure 5350, and the third input structure 5366 are different types of input structures, and additionally are different input structures.

In an aspect, the cofactor input module 5314 is adapted to receive at least one input from a user (i.e., via the user interface 5364). In another aspect, the cofactor input module is adapted to receive at least one input from sensor 5368 (e.g., via data input 5354 or other device interface). In another aspect, the cofactor input module 5314 is adapted to receive at least one input via the computing network 5370.

The user control module 5316 is adapted to receive at least one user control input via a third input structure 5366 of the personal computing device, the user control input for controlling the user controllable stimulation parameters of the ear stimulation device.

Stimulator control module 5318 is adapted to determine at least one stimulation control parameter based on at least one of the mood of the user, the at least one co-factor, and the at least one user control input.

The controller interface module 5320 is for communicating at least one stimulation control parameter to a stimulator controller adapted to control the ear stimulation device in response to the at least one stimulation control parameter.

In an aspect, stimulator control module 5318 is configured to coordinate the delivery of the audio signal and the delivery of the at least one stimulus with ear stimulation device 5302.

In one aspect, the cofactor input module 5314 is adapted to receive at least one input related to the environmental conditions of the user, for example, comprising at least one of light level, temperature, humidity, pollen count, noise level, length of day, precipitation, air quality measurement. In another aspect, the cofactor input module 5314 is adapted to receive at least one input relating to a sleep pattern of a user. In another aspect, the cofactor input module 5314 is adapted to receive at least one input relating to a medical history of the user. In another aspect, the cofactor input module 5314 is adapted to receive at least one input related to the activities of the user, including but not limited to physical activity, health-related activity, entertainment activity, social activity, employment activity, purchasing activity, psychological activity, mental activity, media-related activity, daily living activity, activity amount, activity duration, activity frequency, activity timing, calendar, schedule, or cost. In another aspect, the cofactor input module 5314 is adapted to receive at least one input relating to the user's diet or the user's appetite. The input related to a cofactor may comprise a user input related to the cofactor, for example, received via the user interface 5364. In an aspect, the cofactor input module 5314 is adapted to receive at least one open comment from a user (e.g., via text input 5374). In another aspect, the cofactor input module 5314 is adapted to provide a drop-down menu 5376 of selectable items, and to receive selections from the drop-down menu from a user. For example, in one aspect, the menu of selectable items includes a range of topics for discussion with the medical care provider. In addition to text input or menus, various types of input elements may be utilized to receive input from a user, a conversion of speech to text, a screen element with clickable buttons or checkboxes that allow a user to select from a plurality of options, a slider that allows a user to increase or decrease a parameter value between a minimum and a maximum, and various other types of input elements.

In an aspect, the personal computing device application 5306 includes a recommendation delivery module 5378 configured to present recommendations to the user. For example, the recommendation can be presented to the user via the user interface 5364 or audio output 5326, or sent to a remote device via the device interface 5352, computing network 5370, or communication network 5380. In one aspect, the recommendation delivery module 5378 is adapted to receive recommendations from a healthcare provider, from an insurance company, a service provider, a consultant, a computing-based system, or a social media source. For example, in an aspect, the recommendation delivery module 5378 is adapted to receive recommendations via the computing network 5370. For example, in one aspect, the recommendation is based on patients similar to the user. In an aspect, the recommendation delivery module 5378 is adapted to generate the recommendation.

In an aspect, the personal computing device application 5306 includes a correlation module 5382 configured to determine at least one correlation between the emotion of the user and at least one of the at least one cofactor and the at least one stimulus control parameter, and the recommendation delivery module is configured to generate the recommendation based at least in part on the at least one correlation. For example, if it is determined that a particular cofactor (e.g., rainy weather) is followed by what is typically a depressed mood of the user, then a recommendation is generated to increase the stimulation if the occurrence of the cofactor is detected. As another example, if a user's particular activity is associated with depression (e.g., if the user reports depression after staying up night and not obtaining sufficient sleep, the recommendation may be to sleep earlier).

In one aspect, the recommendation delivery module 5378 is adapted to provide the recommendation to a medical care provider of the user. This can be done, for example, by sending the recommendation to a remote device used by the healthcare provider via the computing network 5370, the communication network 5380, the device interface 5352, or via the user interface 5364. The recommendations are provided to the healthcare provider so that the healthcare provider can discuss the recommendations with the user or, if deemed appropriate, with the user and incorporate the recommendations into the user's overall treatment plan.

In an aspect, the recommendation delivery module 5378 is configured to generate the recommendation based on at least one of information about the subject's response to past treatment regimens, information obtained via social media, information about at least one preference of at least one social media connection of the subject, information about at least one preference of at least one companion of the subject, information about at least one preference of at least one character model of the subject, information from an insurance company, information from a service provider.

In an aspect, the recommendation delivery module 5378 is configured to generate recommendations using a computing-based system; for example, recommendations are generated using artificial intelligence, neural networks, or machine learning systems. In an aspect, recommendation delivery module 5378 is configured to generate a recommendation based on a predicted response of the subject to the treatment regimen.

In another aspect, recommendation delivery module 5378 is configured to receive information regarding whether the subject has accepted or rejected the recommendation. In various aspects, recommendation delivery module 5378 is configured to present to a user a recommendation for a configuration of neural stimulation, or a recommendation for a secondary stimulation delivered in association with the neural stimulation.

In one aspect, the personal computing device application 5306 includes a physiological data module 5384 adapted to receive at least one physiological data signal representative of at least one physiological parameter of the user. In one aspect, the physiological data module 5384 is adapted to receive at least one physiological data signal from at least one sensor 5368. In another aspect, the physiological data module 5384 is adapted to receive at least one physiological data signal from at least one computing network 5370 or alternatively through at least one communication network 5380. In another aspect, the physiological data module 5384 is adapted to receive at least one physiological data signal from at least one telemetry system 5386. The remote sensing system may include one or more sensors in the user's environment including, but not limited to, cameras, motion sensors, pressure sensors, force sensors, infrared sensors, and the like. In various aspects, the physiological data module 5384 is adapted to receive at least one physiological data signal from at least one of a blood pressure sensor, a heart rate sensor, a chemical sensor, a biological sensor, a pH sensor, a blood oxygen sensor, a galvanic skin response sensor, an EEG sensor, an EMG sensor, an ECG sensor, a wearable item, an eye tracking system, an acoustic sensor, a motion sensor, a force sensor, or an activity sensor.

In an aspect, user control module 5316 is adapted to receive user input (e.g., via user interface 5364) for controlling at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope.

In one aspect, the personal computing device application 5306 includes an external control module 5388 configured to receive an external control input for controlling at least one externally controllable stimulation parameter of the ear stimulation device. For example, in various aspects, the external control module 5388 is configured to receive external control inputs via the computing network 5370 or the communication network 5380. In an aspect, the external control module 5388 is configured to receive external control inputs from an external party or entity. In one aspect, the external party or entity is a medical care provider. In other aspects, the external control input may be received from other external parties or entities (e.g., family members, insurance companies, device manufacturers, etc.). The at least one externally controllable stimulation parameter comprises, for example, at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope. The externally controllable stimulation parameters may include preferred values for therapeutic efficacy, including preferred values associated with different patented conditions, or upper and lower limits for stimulation values for patient safety or therapeutic efficacy purposes.

In another aspect, the personal computing device application 5306 includes a data transfer module 5390 for providing data relating to the user to an external party or entity. In an aspect, the data transfer module 5390 is configured to provide data to an external party or entity via the computing network 5370. In another aspect, the data transfer module is configured to provide data to an external party or entity via communication network 5380. For example, the external party or entity may be, for example, a medical services provider, a family member, an insurance company, a service provider, a subject's social media contact (or "friend"), a subject's peer, a consultant, a computing-based system, a social media source, a device manufacturer, a merchant, an electronic medical record, a sensor network, or an add-on or application. In an aspect, the sensor network includes or is part of a health diary platform, a smart home, or an internet of things.

In an aspect, stimulator control module 5318 is configured to determine at least one stimulation control parameter 5334 by overlaying (over) at least one user control input for controlling the at least one user-controllable stimulation parameter based on a medical care provider control input. Alternatively, in another aspect, stimulator control module 5318 is configured to override the medical care provider control input based on at least one user control input for controlling at least one user-controllable stimulation parameter. In yet another aspect, stimulator control module 5318 is configured to override at least one user control input for controlling at least one user-controllable stimulation parameter based on a stimulation control parameter generated by a computing system. In another aspect, stimulator control module 5318 is configured to override the computing system generated stimulation control parameters based on at least one user control input for controlling the at least one user controllable stimulation parameter. For example, stimulator control module 5318 is configured to determine at least one stimulation control parameter based on the at least one user-controllable stimulation parameter to provide an initial setting of the ear stimulation device. In another aspect, stimulator control module 5318 is configured to determine at least one stimulation control parameter based on the at least one user-controllable stimulation parameter to update a setting of the ear stimulation device.

Fig. 54 is a flow chart of a method of controlling an ear stimulation device using a personal computing device. For example, method 5400 may be performed using a personal computing device configured with application software, as depicted and discussed in connection with fig. 53. Method 5400 includes receiving an audio signal at a personal computing device from an audio signal source, as shown at 5402; delivering, by an audio output of the personal computing device, an audio signal to an audio headset worn by the user, the audio headset having an ear stimulation device associated therewith, the ear stimulation device configured to stimulate nerves innervating an ear of the user, as shown at 5404; receiving, with an emotion assessment module, an emotion-related input from a user through a first input structure associated with a personal computing device, as shown at 4106; evaluating, with an emotion evaluation module, an emotion of the user based at least in part on the emotion-related input, as shown at 4108; receiving, with a cofactor input module, at least one input related to at least one cofactor related to a user via a second input structure associated with the personal computing device, as shown at 4110; receiving, with the user control module, at least one user control input through a third input structure associated with the personal computing device for controlling at least one user controllable stimulation parameter of the ear stimulation device, as shown at 4112; determining, with the stimulator control module, at least one stimulation control parameter based on at least one of the mood of the user, the at least one co-factor, and the at least one user control input, as shown at 4114; and communicating, with the controller interface module, the at least one stimulation control parameter to a stimulator controller adapted to control the ear stimulation device in response to the at least one stimulation control parameter, as shown at 4116.

Other aspects of the method shown in fig. 54 are shown in fig. 55-60.

For example, as shown in fig. 55, in aspects of method 5500, receiving an audio signal from an audio signal source at a personal computing device includes receiving an audio signal from an audio player application, as shown at 5502; receiving an audio signal from a network radio application, as shown at 5504; the audio signal is received from a radio receiver, as shown at 5506, from a telephone receiver, as shown at 5508, or from a hearing aid, as shown at 5510.

Receiving emotion-related input in various aspects includes receiving user input through the ecological transient assessment module, as shown at 5512; the user's image is received using the user facing camera of the personal computing device and the mood of the user is determined based on image analysis of the user's image with image processing software of the mood assessment module, as shown at 5514. Mood assessment based on image analysis is discussed in more detail above. Receiving mood-related inputs may include receiving mood-related inputs related to one or more of the depressive disorders, as shown at 5516; pressure, as indicated at 5518; mood, as shown at 5520; or a psychiatric disorder, as indicated in 5522. In one aspect, receiving emotion-related input via the first input structure includes receiving at least one input via a touch screen, a keyboard, or a microphone, as shown at 5524. In an aspect, method 5500 includes coordinating delivery of the audio signal with delivery of the at least one stimulus with the ear stimulation device with a stimulator control module, as shown at 5524.

FIG. 56 provides a further variation of the method of FIG. 41. At 4110, at least one input related to at least one cofactor related to the user is related to being received. In an aspect of the method 5600, receiving at least one input related to at least one cofactor includes receiving the at least one input via at least one of a touch screen, a keyboard, a microphone, a device interface, a data input, a USB port, a wireless interface, a serial port, and a parallel port, as shown at 5602. In other aspects, receiving, by the cofactor input module, at least one input related to at least one cofactor related to a user comprises receiving at least one input from the user, as shown at 5604; receiving at least one input from a sensor, as shown at 5606; or at least one input can be received over a computing network, as shown at 5608.

In another aspect, as shown at 5610, receiving, by the cofactor input module, at least one input related to at least one cofactor related to the user includes receiving at least one input related to an environmental condition of the user. The environmental condition may be, for example, at least one of a light level, a temperature, a humidity, a pollen count, a noise level, a length of day, precipitation, an air quality measurement, as shown at 5612.

In other aspects, receiving, by the cofactor input module, at least one input related to at least one cofactor related to a user comprises receiving at least one input related to a sleep pattern of the user, as shown at 5614; the user's medical history, as shown at 5615; the user's diet, as shown at 5616; the user's stoma, as shown at 5618; or activity of the user, as shown at 5620. For example, receiving at least one input related to an activity includes receiving at least one input related to, for example, physical activity, entertainment activity, social activity, employment activity, purchasing activity, mental activity, media-related activity, daily living activity, amount of activity, duration of activity, frequency of activity, timing of activity, calendar, schedule, or fee, as shown at 5622.

In another aspect, receiving at least one input related to at least one cofactor related to a user with the cofactor input module includes receiving at least one open comment from the user, as shown at 5624. In other aspects, receiving at least one input related to at least one cofactor related to the user with the cofactor input module includes providing a drop down menu of selectable items and receiving a selection from the drop down menu from the user, as shown at 5626. For example, in one aspect, providing a drop down menu of selectable items includes providing a drop down menu of selectable topical areas for discussion with a medical care provider, as shown at 5628.

As shown in fig. 57, in an aspect, the method 5700 includes presenting recommendations to a user using a recommendation delivery module, as shown at 5702. Recommendations may be received from healthcare providers, from insurance companies, service providers, consultants, computing-based systems or social media sources, as shown at 5704, or from computing networks, as shown at 5706. In another aspect, the method 5700 includes providing recommendations to a medical service provider of a user using a recommendation delivery module, as shown at 5708. In another aspect, the method 5700 includes receiving, with the recommendation delivery module, information regarding whether the subject has accepted or rejected the recommendation, as shown at 5710.

In aspects, presenting recommendations includes presenting recommendations for configurations of neural stimulation, as shown at 5712, or presenting recommendations of secondary stimulation delivered in association with neural stimulation, as shown at 5714.

In one aspect, the method 5700 includes communicating recommendations based on a patient similar to the user, as shown at 5716.

In an aspect, the method 5700 includes generating a recommendation with a recommendation delivery module, as shown at 5718. For example, the method can include determining, with a correlation module, a correlation between the mood of the user and at least one of the at least one cofactor and the at least one stimulus control parameter, and generating, with a recommendation delivery module, a recommendation based at least in part on the at least one correlation, as shown at 5720. In one aspect, the method includes generating a recommendation based on at least one of information about the subject's response to past treatment regimens, information obtained through social media, information about at least one preference of at least one social media contact of the subject, information about at least one preference of at least one peer of the subject, information about at least one preference of at least one character model of the subject, information from an insurance company, information from a service provider, as shown at 5722. In some aspects, the method includes generating a recommendation using a computing-based system, as shown at 5724, or generating a recommendation based on a predicted response of the subject to a treatment regimen, as shown at 5726.

Fig. 58 depicts aspects of a correlation method 5800. In one aspect, method 5800 includes receiving, with a physiological data module, at least one physiological data signal representative of at least one physiological parameter of a user, as shown at 5802. Receiving at least one physiological data signal includes, for example, receiving at least one physiological data signal from at least one sensor, as shown at 5804. In one aspect, at least one sensor is located on an audio headset associated with the ear stimulation device, as shown at 5806. In one aspect, the audio headset with the ear stimulation device associated therewith is a first audio headset worn on a first ear of the subject, and wherein the at least one sensor is located on a second audio headset located on a second ear of the subject, as shown at 5808.

In one aspect, receiving at least one physiological data signal includes receiving at least one physiological data signal from at least one computing network, as shown at 5810, or receiving at least one physiological data signal from at least one telemetry system, as shown at 5812. In aspects, receiving the at least one physiological data signal comprises receiving the at least one physiological data signal from at least one of a blood pressure sensor, a heart rate sensor, a chemical sensor, a biological sensor, a pH sensor, a blood oxygen sensor, a galvanic skin response sensor, an EEG sensor, an EMG sensor, an ECG sensor, a wearable item, an eye tracking system, an acoustic sensor, a motion sensor, a force sensor, or an activity sensor, as shown at 5814.

In another aspect, method 5800 includes providing data related to a user to an external party or entity, as shown at 5816. In aspects, providing data to an external party or entity includes providing data via a computing network, as indicated at 5818, or providing data over a communication network, as shown at 5820. In one aspect, providing the data to the external party or entity includes providing the data to a healthcare provider, as shown at 5822. In aspects, providing data to an external party or entity includes providing data to family members, insurance companies, service providers, social media contacts of the subject, peers of the subject, consultants, computing-based systems, social media sources, device manufacturers, merchants, electronic medical records, sensor networks, programs, or applications, as shown at 5824.

Fig. 59 depicts further aspects of method 5900. In one aspect of method 5900, receiving at least one user control input for controlling at least one user-controllable stimulation parameter includes receiving at least one user input for controlling at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope, as shown at 5902.

In another aspect, method 5900 includes determining, with a correlation module, at least one correlation between an emotion of the user and at least one of the at least one co-factor and the at least one stimulation control parameter, as shown at 5904.

In another aspect, method 5900 includes receiving, with an external control module, an external control input for controlling at least one externally controllable stimulation parameter of the ear stimulation device, as shown at 5906. In various aspects, this includes receiving external control inputs via a computing network and a communication network, as shown at 5908. In one aspect, receiving the external control input includes receiving the external control input from an external party or entity, as shown at 5910, for example, a medical care provider, as indicated at 5912, or a family member, an insurance company, a service provider, a social media contact of the subject, a companion of the subject, an advisor, a computing-based system, a social media source, a device manufacturer, a merchant, an electronic medical record, a sensor network, a program, or an application, as shown at 5914. In aspects, the at least one externally controllable stimulation parameter includes at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope, as shown at 5916.

Fig. 60 depicts further aspects of method 6000, which involves determining at least one stimulation control parameter. In an aspect, determining the at least one stimulation control parameter includes overriding at least one user control input for controlling the at least one user-controllable stimulation parameter based on the medical care provider control input, as shown at 6002. In another aspect, determining the at least one stimulation control parameter includes overriding a healthcare provider control input based on the at least one user control input for controlling the at least one user-controllable stimulation parameter, as shown at 6004. In another aspect, determining the at least one stimulation control parameter includes overriding the at least one user control input for controlling the at least one user-controllable stimulation parameter based on the computing system generated stimulation control parameter, as shown at 6006. In another aspect, determining the at least one stimulation control parameter includes overriding the computing system generated stimulation control parameter based on at least one user control input for controlling the at least one user controllable stimulation parameter.

In an aspect, determining the at least one stimulation control parameter includes determining an initial setting of the ear stimulation device based on the at least one user-controllable stimulation parameter, as shown at 6010. In another aspect, determining at least one stimulation control parameter includes updating a setting of the ear stimulation device based on the at least one user-controllable stimulation parameter, as shown at 6012.

Aspects of the subject matter described herein are set forth in the following numbered clauses:

1.a neurostimulation headset, comprising:

an ear canal insert adapted to fit into an ear canal of a human subject, the ear canal insert comprising at least one first electrode configured to electrically contact skin within the ear canal of the subject;

an outer ear insert adapted to fit within the outer ear of the subject, the outer ear insert comprising a base configured to fit within a cavity of the outer ear of the subject;

a wing configured to fit within a boat of the outer ear of the subject; and

at least one second electrode configured to electrically contact at least a portion of the outer ear of the subject;

at least one first electrical connector for connecting the at least one first electrode on the ear canal insert to a first current source; and

at least one second electrical connector for connecting said at least one second electrode on said outer ear insert to a second current source.

2. The neurostimulation earpiece of clause 1, wherein the ear canal insert comprises a sound delivery portion adapted to deliver sound to the ear canal of the subject.

3. The neurostimulation headset of clause 1, further comprising wireless communication circuitry.

4. The neurostimulation headset of clause 3, wherein the wireless communication circuitry is adapted for receiving an audio signal.

5. The neurostimulation headset of clause 3, wherein the wireless communication circuitry is adapted for transmitting or receiving data signals.

6. The neurostimulation headset of clause 3, wherein the wireless communication circuitry comprises bluetooth communication circuitry.

7. The neurostimulation earpiece of clause 2, further comprising at least one mounting structure adapted for physically mounting at least one of the concha insert and the ear canal insert to a body structure of an audio earpiece.

8. The neurostimulation headset of clause 7, wherein the at least one mounting structure comprises a recess in the base portion of the concha insert, the recess adapted to receive a protrusion of the body structure of the audio headset.

9. The neurostimulation earpiece according to clause 7, wherein the at least one mounting structure comprises a recess coaxial with the ear canal insert and adapted to receive a protrusion of a body structure of the audio earpiece.

10. The neurostimulation earpiece of clause 9, wherein the recess is formed in the interior of the ear canal insert.

11. The neurostimulation headset of clause 9, wherein the at least one mounting structure comprises a resilient conductive element extending inwardly along at least a portion of an inner circumference of the recess, wherein the conductive element is adapted to snap into an annular groove around an outer circumference of the protrusion of the body structure of the audio headset to make electrical contact with a circular conductive element in the annular groove while making a mechanical connection with the annular groove.

12. The neurostimulation headset of clause 7, wherein the at least one mounting structure comprises at least one of a pin or a socket on the base of the concha insert configured to complementarily mate with at least one of a socket or a pin on a body structure of the audio headset, wherein the at least one of a pin or a socket on the base of the concha insert provides both electrical and mechanical connection of the base of the concha insert to the body structure of the audio headset.

13. The neurostimulation headset of clause 7, wherein the at least one mounting structure comprises at least one of a clip or a socket on the base of the concha insert configured to complementarily mate with at least one of a socket or a clip on a body structure of the audio headset, wherein the at least one of a clip or a socket on the base of the concha insert provides both electrical and mechanical connection of the base of the concha insert to the body structure of the audio headset.

14. The neurostimulation headset of clause 7, wherein the at least one mounting structure comprises at least one clip element configured to mate with a complementary clip element on a body structure of the audio headset.

15. The neurostimulation earpiece of clause 7, wherein the sound delivery portion comprises a passage through the ear canal insert to allow sound to be delivered from the speaker in the audio earpiece through the ear canal insert to the ear canal of the subject.

16. The neurostimulation headset of clause 7, wherein the sound delivery portion comprises a speaker in the audio headset.

17. The neurostimulation headset of clause 7, wherein the base of the concha insert comprises a through hole, and wherein at least one of the body structure of the audio headset or the canal insert comprises a protrusion configured to fit through the through hole to mate with a complementary portion of the other of the body structure of the audio headset or the canal insert to secure the canal insert and the concha insert to the body structure of the audio headset.

18. The neurostimulation headset of clause 17, wherein the body structure of the audio headset comprises the protrusion, wherein the through-hole has a non-circular shape, and wherein at least a portion of the protrusion has a non-circular shape that is complementary to the shape of the through-hole, such that when the protrusion is fitted into the through-hole, the concha insert is prevented from rotating relative to the body structure of the audio headset.

19. The neurostimulation headset of clause 17, wherein the base of the concha insert and the body structure of the audio headset comprise complementary mating features adapted to prevent rotation of the concha insert relative to the body structure of the audio headset.

20. The neurostimulation headset of clause 17, wherein the protrusion and the complementary portion are configured to mate by a threaded connection.

21. The neurostimulation headset of clause 17, wherein the protrusion and the complementary portion are configured to mate by a friction fit.

22. The neurostimulation headset of clause 17, wherein the protrusion and the complementary portion are configured to mate by snap-fitting.

23. The neurostimulation headset of clause 17, wherein the concha insert has a first face adapted to face towards the concha of the subject and a second face adapted to face away from the concha of the subject and towards the body structure of the audio headset, and wherein the base portion of the concha insert and the body structure of the audio headset comprise complementary mating features adapted to enable assembly of the concha insert onto the body structure of the audio headset with the second face facing towards the body structure of the audio headset and to prevent assembly of the concha insert onto the body structure of the audio headset with the first face facing towards the body structure of the audio headset.

24. The neurostimulation earphone of clause 1, wherein the ear canal insert and the outer ear insert together are configured to fit within one of the right or left ear of the subject and not the other of the right or left ear of the subject.

25. The neurostimulation headset of clause 1, wherein the outer ear insert is shaped to fit within an outer ear of one of the right or left ear of the subject and not in the other of the right or left ear of the subject.

26. The neurostimulation headset of clause 1, wherein at least a portion of the neurostimulation headset comprises a disposable material.

27. The neurostimulation earpiece of clause 1, wherein the wing portion of the concha insert comprises a soft, deformable, compliant, flexible or elastic material.

28. The neurostimulation earphone of clause 1, wherein the wing portion of the concha insert comprises a rigid material.

29. The neurostimulation headset of clause 1, wherein the at least one first electrode has an area between about 190mm²And about 380mm²The electrical contact area therebetween.

30. The neurostimulation headset of clause 1, wherein the at least one second electrode has an electrode diameter of between about 100mm²And about 220mm²The electrical contact area therebetween.

31. The neurostimulation earphone of clause 1, wherein the base of the concha insert comprises a hard material.

32. The neurostimulation headset of clause 1, wherein the first current source and the second current source are first and second terminals of a single current source.

33. The neurostimulation headset of clause 32, wherein the single current source is located on the neurostimulation headset.

34. The neurostimulation headset of clause 32, wherein the single current source is connected to the at least one first electrical connector and the at least one second electrical connector via a wired connection.

35. The neurostimulation headset of clause 1, wherein at least one of the at least one first electrode or the at least one second electrode comprises a silver/silver chloride composition.

36. The neurostimulation headset of clause 1, wherein at least one of the at least one first electrode or the at least one second electrode comprises a conductive gel.

37. The neurostimulation headset of clause 1, wherein at least one of the at least one first electrode or the at least one second electrode comprises a hydrogel.

38. The neurostimulation headset of clause 1, wherein at least one of the at least one first electrode or the at least one second electrode comprises a conductive polymer.

39. The neurostimulation headset of clause 1, wherein at least one of the at least one first electrode or the at least one second electrode is a conductive foam.

40. The neurostimulation headset of clause 1, wherein at least one of the at least one first electrode or the at least one second electrode comprises a fabric.

41. The neurostimulation headset of clause 1, wherein at least one of the at least one first electrode or the at least one second electrode comprises a layered structure comprising a hydrogel layer and a conductive polymer layer.

42. The neurostimulation headset of clause 1, further comprising a physiological sensor.

43. The neurostimulation headset of clause 42, wherein the physiological sensor comprises a photoplethysmograph probe.

44. The neurostimulation headset of clause 43, wherein the photoplethysmograph probe includes a 660nm red wavelength LED and a 940nm infrared wavelength LED.

45. The neurostimulation headset of clause 42, wherein the physiological sensors comprise EEG sensors.

46. The neurostimulation headset of clause 42, wherein the physiological sensor comprises a heart rate sensor.

47. The neurostimulation headset of clause 42, wherein the physiological sensor comprises a humidity sensor.

48. The neurostimulation headset of clause 42, wherein the physiological sensor comprises a temperature sensor.

49. The neurostimulation headset of clause 42, wherein the physiological sensor comprises a biosensor.

50. The neurostimulation headset of clause 42, wherein the physiological sensor comprises a chemical sensor.

51. An ear stimulation device controller, comprising:

a first analog output connector adapted to connect a first current signal to a first electrode of an ear canal insert of an ear stimulation device;

a second analog output connector adapted to connect a second current signal to a second electrode of an outer ear insert of the ear stimulation device;

a wireless microcontroller configured to control wireless communication between the ear stimulation device controller and a personal computing device to receive one or more stimulation parameters from the personal computing device;

a digital stimulation signal generator configured to generate a digital stimulation signal based at least in part on the one or more stimulation parameters received from the personal computing device;

a digital-to-analog converter for converting the digital stimulation signal to an analog voltage waveform;

a current driver operably connected to the digital-to-analog converter and adapted to generate a controlled current stimulation waveform in response to the analog voltage waveform, wherein the controlled current stimulation waveform is provided to the ear stimulation device via at least the first and second analog output connectors; and

a power source operably connected to at least one of the wireless microcontroller, the digital stimulation signal generator, the digital-to-analog converter, and the current driver.

52. The ear stimulation device controller of clause 51, wherein the wireless microcontroller is a CC2650 microcontroller.

53. The ear stimulation device controller of clause 51, wherein the wireless microcontroller is compatible with a JTAG standard debug interface.

54. The ear stimulation device controller of clause 51, wherein the wireless microcontroller comprises a plurality of general purpose input/output pins.

55. The ear stimulation device controller of clause 51, wherein the wireless microcontroller comprises a configurable serial peripheral interface.

56. The ear stimulation device controller of clause 51, wherein the wireless microcontroller is a bluetooth controller.

57. The ear stimulation device controller of clause 51, further comprising a printed circuit board.

58. The ear stimulation device controller of clause 57, wherein the printed circuit board comprises a first signal layer, a ground layer, a power layer, and a second signal layer.

59. The ear stimulation device controller of clause 57, wherein the printed circuit board includes separate analog and digital ground areas to avoid introducing noise.

60. The ear stimulation device controller of clause 57, wherein the printed circuit board comprises one or more de-noising capacitors.

61. The ear stimulation device controller of clause 57, wherein the printed circuit board comprises an antenna.

62. The ear stimulation device controller of clause 57, wherein the printed circuit board comprises one or more isolator chips located between the microcontroller and the digital-to-analog converter.

63. The ear stimulation device controller of clause 51, wherein the digital-to-analog converter comprises two or more output channels, wherein at least one of the two or more output channels generates an inverted signal relative to another of the two or more output channels.

64. The ear stimulation device controller of clause 51, wherein the digital-to-analog converter is a 16-bit digital-to-analog converter.

65. The ear stimulation device controller of clause 51, wherein the digital-to-analog converter is a 14-bit digital-to-analog converter.

66. The ear stimulation device controller of clause 51, wherein the digital-to-analog converter is an 8-bit digital-to-analog converter.

67. The ear stimulation device controller of clause 51, wherein the digital-to-analog converter is a single channel digital-to-analog converter.

68. The ear stimulation device controller of clause 51, wherein the digital-to-analog converter is a multi-channel digital-to-analog converter.

69. The ear stimulation device controller of clause 51, wherein the digital-to-analog converter is DAC 8163.

70. The ear stimulation device controller of clause 57, further comprising a signal inverter adapted to invert the analog voltage waveform output by the digital-to-analog converter.

71. The ear stimulation device controller of clause 57, further comprising a signal inverter adapted to invert the analog current waveform output by the current driver.

72. The ear stimulation device controller of clause 51, further comprising a cell phone housing comprising a recess adapted to receive a cellular telephone.

73. The ear stimulation device controller of clause 72, further comprising a micro-USB connector adapted to mate with a microUSB port of a cellular telephone.

74. The ear stimulation device controller of clause 51, wherein the current driver is adapted to produce a controlled current output that is not affected by the load impedance.

75. The ear stimulation device controller of clause 51, wherein the current driver is an XTR300 analog current/voltage output driver.

76. The ear stimulation device controller of clause 51, wherein the current driver is adapted to produce a controlled current output that is not affected by the load impedance.

77. The ear stimulation device controller according to clause 51, wherein the current driver is adapted to provide biphasic current stimulation.

78. The ear stimulation device controller of clause 51, wherein the current driver is adapted to provide a current output of between-100 mA and +100 mA.

79. The ear stimulation device controller of clause 78, wherein the current driver provides a current output of between-20 mA and +20mA at a maximum voltage of 10V.

80. The ear stimulation device controller of clause 51, wherein the current driver is adapted to receive a power input of ± 15V.

81. The ear stimulation device controller of clause 51, wherein the current driver is adapted to receive an input signal voltage of ± VDD-3 and an external reference voltage.

82. The ear stimulation device controller of clause 51, wherein the current driver is adapted to provide an over-temperature, an over-current, and a common mode over-range error signal.

83. The ear stimulation device controller of clause 51, wherein the current driver comprises an internal instrumentation amplifier adapted to provide a copy of the stimulation current through the set resistor via an IA channel.

84. The ear stimulation device controller of clause 51, wherein the current driver comprises an internal operational amplifier configured to provide 1/10 current copies.

85. The ear stimulation device controller of clause 51, wherein the current driver is adapted to generate the current pulses at a pulse frequency of no more than 1 kHz.

86. The ear stimulation device controller according to clause 51, wherein the current driver is adapted to generate current pulses with a pulse frequency not exceeding 500 Hz.

87. The ear stimulation device controller according to clause 51, wherein the current driver is adapted to generate current pulses having a pulse duration of no more than 2 ms.

88. The ear stimulation device controller of clause 51, wherein the current driver is adapted to generate current pulses having a voltage of no more than ± 40V.

89. The ear stimulation device controller of clause 51, wherein the current driver is adapted to generate the current pulses with a voltage compliance of no greater than ± 10V.

90. The ear stimulation device controller of clause 51, wherein the current driver is adapted to generate current pulses having a maximum average current of no greater than 10 mA.

91. The ear stimulation device controller of clause 51, wherein the current driver is adapted to generate the current pulse with a maximum primary depolarization phase duration of no greater than 500 ms.

92. The ear stimulation device controller of clause 51, wherein the current driver is adapted to generate current pulses having a maximum average DC current of no greater than 100mA during non-pulse or device failure.

93. The ear stimulation device controller of clause 51, wherein the power source comprises a battery.

94. The ear stimulation device controller of clause 93, wherein the battery is a 3.7V lithium polymer battery.

95. The ear stimulation device controller of clause 93, comprising a microUSB port connected to the battery and configured to connect the battery to a power source for recharging.

96. The ear stimulation device controller of clause 51, wherein the power source provides 3.3V.

97. The ear stimulation device controller of clause 51, wherein the power source comprises an MCP7383x battery protection integrated circuit.

98. The ear stimulation device controller of clause 51, wherein the power source provides voltage and current protection in the event of unstable behavior, overcharging, or energy depletion in the battery.

99. The ear stimulation device controller of clause 51, wherein the power supply is configured to automatically shut off current upon detection of overcharge, overdischarge, or a short circuit.

100. The ear stimulation device controller of clause 99, wherein the power source is configured to resume operation upon expiration of an internal timer.

101. The ear stimulation device controller of clause 51, wherein the power source comprises a micro-USB connector configured to connect to a power output of the mobile phone via a micro-USB port.

102. The ear stimulation device controller of clause 51, wherein the power source comprises an audio jack connector configured to connect to a power output of the mobile phone via a phone audio jack.

103. The ear stimulation device controller of clause 51, further comprising a housing, wherein the housing comprises a recess adapted to receive the personal computing device.

104. The ear stimulation device controller of clause 103, wherein the recess is adapted to receive a mobile phone.

105. The ear stimulation device controller of clause 103, wherein the recess is adapted to receive a tablet computer.

106. The ear stimulation device controller of clause 51, further comprising an attachment means for attaching the housing to the personal computing device.

107. The ear stimulation device controller of clause 51, wherein the wireless microcontroller is configured to communicate one or more data signals between the ear stimulation device controller and the mobile phone via a microUSB connection.

108. The ear stimulation device controller of clause 51, wherein the wireless microcontroller is configured to communicate one or more data signals between the ear stimulation device controller and the mobile phone through the audio jack of the mobile phone.

109. The ear stimulation device controller of clause 51, wherein the wireless microcontroller is configured to communicate one or more data signals between the ear stimulation device controller and the mobile phone via the wireless connection.

110. The ear stimulation device controller of clause 51, comprising an internal timer.

111. The ear stimulation device controller of clause 51, wherein the current driver is capable of providing current to two or more stimulation channels, and wherein the two or more stimulation channels are electrically isolated from each other.

112. The ear stimulation device controller of clause 51, further comprising a physiological signal input adapted to receive a physiological signal.

113. The ear stimulation device controller of clause 112, wherein the first analog output connector and the second analog output connector are configured to connect to an ear stimulation device located on a first ear of the user, and wherein the physiological signal input is configured to receive the physiological signal from a physiological sensor located on a second ear of the user.

114. A neurostimulation system, comprising:

a nerve stimulation earphone, which comprises

An ear canal insert adapted to fit into an ear canal of a human subject, the ear canal insert comprising

At least one first electrode configured to electrically contact skin within the ear canal of the subject;

an outer ear insert adapted to fit within the outer ear of the subject, the outer ear insert comprising

A base configured to fit within a cavity of the outer ear of the subject;

a wing configured to fit within a boat of the outer ear of the subject; and

at least one second electrode configured to electrically contact at least a portion of the outer ear of the subject;

at least one first electrical connector for connecting the at least one first electrode on the ear canal insert to a first current source; and

at least one second electrical connector for connecting said at least one second electrode on said outer ear insert to a second current source, an

An ear stimulation device controller comprising

A first analog output connector adapted to connect a first current signal to at least one first electrode of the neurostimulation headset;

a second analog output connector adapted to connect a second current signal to the at least one second electrode of the neurostimulation headset;

a wireless microcontroller configured to control wireless communication between the ear stimulation device controller and a personal computing device to receive one or more stimulation parameters from the personal computing device;

a digital stimulation signal generator configured to generate a digital stimulation signal based at least in part on the one or more stimulation parameters received from the personal computing device;

a digital-to-analog converter for converting the digital stimulation signal to an analog voltage waveform;

a current driver operably connected to the digital-to-analog converter and adapted to generate a controlled current stimulation waveform in response to the analog voltage waveform, wherein the controlled current stimulation waveform is provided to the ear stimulation device via at least the first and second analog output connectors; and

a power source operably connected to at least one of the wireless microcontroller, the digital stimulation signal generator, the digital-to-analog converter, and the current driver.

115. The neurostimulation system of clause 114, wherein the neurostimulation headset comprises a physiological sensor, and wherein the ear stimulation device controller comprises a physiological signal input configured for receiving a physiological signal from the physiological sensor.

116. The neurostimulation system of clause 114, wherein the neurostimulation headset is operatively coupled to the audio headset.

117. The neurostimulation system of clause 114, wherein the personal computing device comprises a mobile phone.

118. The neurostimulation system of clause 114, wherein the neurostimulation headset comprises a wireless communication circuit adapted for receiving or transmitting at least one of an audio signal and a data signal.

119. The neurostimulation system of clause 118, wherein the audio signal is received from a personal computing device.

120. The neurostimulation system of clause 118, wherein the data signal is sent or received from at least one of a personal computing device and an ear stimulation device controller.

115. A method of controlling an ear stimulation device with a personal computing device, comprising:

capturing, with an image capture circuit on the personal computing device, an image of a user of the personal computing device through a user-facing camera associated with the personal computing device;

processing the image using image processing circuitry on the personal computing device to determine at least one parameter; and

controlling, with a neural stimulation control signal determination circuit on the personal computing device, delivery of stimulation to at least one nerve innervating an ear of the user with the ear stimulation device based at least in part on the at least one parameter.

116. The method of clause 1, wherein the image processing circuitry comprises application software on the personal computing device.

117. The method of clause 1, wherein the at least one parameter represents at least one emotion of the user.

118. The method of clause 1, wherein the at least one parameter is representative of a physiological condition of the user.

119. The method of clause 1, wherein the at least one parameter is indicative of a medical condition of the user.

120. The method of clause 1, wherein the at least one parameter represents an identity of a user.

121. The method of clause 1, wherein the at least one parameter is a heart rate of the user.

122. The method of clause 1, wherein the at least one parameter relates to eye position or eye movement of the user.

123. The method of clause 1, wherein the at least one parameter is representative of a position of an ear piece of the ear stimulation device relative to an ear of the user.

124. The method of clause 9, which includes delivering, to the user, under control of a notification circuit on the personal computing device, a notification announcing that the user needs to adjust the position of the headset relative to the ear of the user.

125. The method of clause 10, wherein delivering the notification to the user comprises delivering a text notification.

126. The method of clause 10, wherein delivering the notification to the user comprises delivering a visible notification.

127. The method of clause 10, wherein delivering the notification to the user comprises delivering an audio notification.

128. The method of clause 1, wherein the personal computing device comprises a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer.

129. The method of clause 1, which comprises:

processing the image using the image processing circuit to determine

The presence of at least one earpiece of the ear stimulation device positioned at the user's ear;

an ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and

at least one attribute of the at least one earpiece representative of the at least one earpiece's usability for one of the left or right ear of the user;

determining, using application software on the personal computing device, an ear that can use the headset based on the at least one attribute of the at least one headset;

determining, using application software on the personal computing device, whether the ear in which the at least one earpiece is located is the ear in which the earpiece is available; and is

If the ear in which the at least one earpiece is located is not the ear in which the earpiece is available, sending a control signal from the personal computing device to the ear stimulation device under control of the neurostimulation control signal determination circuitry to prevent delivery of stimulation through the earpiece to the ear in which the earpiece is located.

130. The method of clause 15, which includes receiving, with a handshaking circuit on the personal computing device, a handshaking signal from an ear stimulation device control circuit associated with the ear stimulation device.

131. The method of clause 16, which includes capturing the image of the user of the personal computing device in response to receiving the handshake signal from the ear stimulation device control circuit.

132. The method of clause 16, including sending a handshake signal to the ear stimulation device control circuit in response to determining the presence of the at least one earpiece located at the ear of the user in the image.

133. The method of clause 15, which includes sending a notification to the user under control of a notification circuit on the personal computing device announcing that the user needs to switch the headset to another ear if the ear in which the at least one headset is located is not the ear with which the headset is usable.

134. The method of clause 19, wherein delivering the notification to the user comprises delivering a text notification.

135. The method of clause 19, wherein delivering the notification to the user comprises delivering a visible notification.

136. The method of clause 19, wherein delivering the notification to the user comprises delivering an audio notification.

137. The method of clause 15, wherein determining the at least one attribute of the at least one earpiece comprises determining a shape of the at least one earpiece.

138. The method of clause 15, wherein determining the at least one attribute of the at least one earpiece comprises determining a color of the at least one earpiece.

139. The method of clause 15, wherein determining the at least one attribute of the at least one earpiece includes determining the presence of a label on the at least one earpiece or an accessory of the at least one earpiece.

140. The method of clause 25, wherein the accessory of the at least one headset comprises a cable connected to the at least one headset.

141. An ear stimulation device control system, comprising:

a personal computing device;

a user-facing camera associated with the personal computing device;

an image capture circuit adapted to capture an image of a user of the personal computing device from the user-facing camera;

an image processing circuit configured to process the image to determine at least one parameter; and

a neural stimulation control signal determination circuit configured to control delivery of stimulation with an ear stimulation device to at least one nerve innervating an ear of the user based at least in part on the at least one parameter.

142. The system of clause 27, wherein the at least one parameter is indicative of at least one emotion of the user.

143. The system of clause 27, wherein the at least one parameter is indicative of a physiological condition of the user.

144. The system of clause 27, wherein the at least one parameter is indicative of an identity of a user.

145. The system of clause 27, wherein the at least one parameter is a heart rate of the user.

146. The system of clause 27, wherein the at least one parameter relates to eye position or eye movement of the user.

147. The system of clause 27, wherein the at least one parameter indicates a position of the headset relative to the user's ear.

148. The system of clause 27, wherein the personal computing device comprises a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer.

149. The system of clause 27, wherein the image processing circuitry comprises a headset position module configured to process the image to determine

The presence of at least one earpiece of the ear stimulation device located at the user's ear;

an ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and

at least one attribute of the at least one earpiece representative of the at least one earpiece's usability for one of the left or right ear of the user; and is

Wherein the neural stimulation control signal determination circuit is configured to

Determining an ear that can use the headset based on the at least one attribute of the at least one headset;

determining whether the ear in which the at least one earphone is located is the ear in which the earphone can be used; and is

Sending a control signal from the personal computing device to the ear stimulation device to prevent the stimulus from being delivered to the at least one nerve innervating the ear of the user if the ear in which the at least one earpiece is located is not the ear in which the earpiece is usable.

150. The system of clause 35, which includes a handshaking circuit adapted to receive a handshaking signal from an ear stimulation device control circuit associated with an ear stimulation device.

151. The system of clause 36, wherein the image capture circuit is adapted to capture an image of a user of the personal computing device in response to receiving the handshake signal from the ear stimulation device control circuit.

152. The system of clause 36, wherein the neurostimulation control signal determination circuit is configured for sending the handshake signal to the ear stimulation device control circuit in response to determining the presence of the at least one earpiece positioned at the user's ear in the image.

153. The system of clause 35, including

An output device; and

a notification circuit adapted to provide a notification through the output device instructing the user to switch the headset to the other ear if the ear in which the at least one headset is located is not an ear in which the headset is usable.

154. The system of clause 39, wherein the output device is adapted to deliver a text notification to the user.

155. The system of clause 39, wherein the output device is adapted to communicate a visible notification to the user.

156. The system of clause 39, wherein the output device is adapted to deliver an audio notification to the user.

157. The system of clause 35, wherein the at least one attribute of the at least one earpiece includes a shape of the at least one earpiece.

158. The system of clause 35, wherein the at least one attribute of the at least one headset comprises a color of the at least one headset.

159. The system of clause 35, wherein the at least one attribute of the at least one headset comprises a label on the at least one headset or a presence of an accessory on the at least one headset.

160. The system of clause 45, wherein the accessory of the at least one headset comprises a cable connected to the at least one headset.

161. A method of controlling an ear stimulation device with a personal computing device, comprising:

detecting, at an electrical signal input circuit, an electrical signal representative of electrical contact of at least one first electrode with the ear of a user of a personal computing device via at least one first electrode of an earpiece of an ear stimulation device, wherein the at least one ear is operatively connected to the personal computing device, and wherein the ear stimulation device is adapted to stimulate at least one nerve innervating the ear of the user of the personal computing device;

determining, using contact determination circuitry on the personal computing device, whether the at least one first electrode is in good electrical contact with the ear of the user;

if the at least one first electrode is not in good electrical contact with the ear of the user, sending a control signal from the personal computing device to the ear stimulation device under control of a neurostimulation control signal determination circuit on the personal computing device to prevent delivery of stimulation through the headphones to the ear in which the headphones are located; and

communicating a notification to the user regarding the state of the at least one first electrode under control of a notification circuit on the personal computing device.

162. The method of clause 1, wherein the personal computing device comprises a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer.

163. The method of clause 1, which includes receiving, at a handshaking circuit on a personal computing device, a handshaking signal from an ear stimulation device control circuit associated with an ear stimulation device.

164. The method of clause 1, which includes delivering an electrical test signal via at least one second electrode of the at least one earpiece under control of a test signal circuit on the personal computing device, and detecting the electrical signal via the at least one first electrode in response to the electrical test signal.

165. The method of clause 4, which includes determining an electrical impedance between the at least one first electrode and the at least one second electrode.

166. The method of clause 1, wherein determining whether the at least one first electrode is in good electrical contact with the user's ear comprises determining the magnitude of the electrical signal.

167. The method of clause 1, wherein determining whether the at least one first electrode is in good electrical contact with the user's ear comprises determining a signal-to-noise ratio of the electrical signal.

168. The method of clause 1, which includes delivering an audio test signal via a sound source associated with the at least one earpiece under control of a test signal circuit on the personal computing device, and determining proper placement of the at least one earpiece based on audio feedback.

169. The method of clause 1, wherein determining whether the at least one first electrode is in good electrical contact with the user's ear comprises determining a phase shift or frequency content of the electrical signal.

170. The method of clause 1, wherein communicating the notification to the user comprises instructing the user to reposition the headset.

171. The method of clause 1, wherein communicating the notification to the user comprises instructing the user to replace at least a portion of the at least one first electrode.

172. The method of clause 1, wherein communicating the notification to the user comprises instructing the user to clean at least a portion of the at least one first electrode.

173. The method of clause 1, wherein communicating the notification to the user comprises instructing the user to wet at least a portion of the at least one first electrode.

174. The method of clause 1, wherein communicating the notification to the user comprises instructing the user to apply the gel to at least a portion of the at least one first electrode.

175. The method of clause 1, wherein delivering the notification to the user comprises delivering a text notification.

176. The method of clause 1, wherein delivering the notification to the user comprises delivering a visible notification.

177. The method of clause 1, wherein delivering the notification to the user comprises delivering an audio notification.

178. The method of clause 1, wherein delivering the notification to the user comprises delivering a directional notification.

179. An ear stimulation device control system, comprising:

a personal computing device configured to control delivery to at least one nerve innervating an ear of a user of the personal computing device via an ear stimulation device, the ear stimulation device comprising an earpiece including at least one first electrode, the personal computing device comprising

An electrical signal input circuit adapted to receive an electrical signal representative of electrical contact of the at least one first electrode with the ear of a user of the personal computing device;

a contact determination circuit configured to determine whether the at least one first electrode is in good electrical contact with the ear of the user;

a neural stimulation control signal determination circuit configured to send a control signal from the personal computing device to the ear stimulation device to prevent delivery of the stimulation if the at least one first electrode is not in good electrical contact with the ear of the user; and

a notification circuit configured to deliver a notification to the user regarding the state of the at least one first electrode.

180. The system of clause 19, wherein the personal computing device comprises a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer.

181. The system of clause 19, which includes a handshaking circuit adapted to receive a handshaking signal from an ear stimulation device control circuit associated with the ear stimulation device.

182. The system of clause 19, which includes a test signal circuit configured to deliver an electrical test signal via at least one second electrode of the at least one ear stimulation device and to detect the electrical signal via the at least one first electrode in response to the electrical test signal.

183. The system of clause 22, wherein the contact determination circuit is configured to determine an electrical impedance between at least one first electrode and at least one second electrode.

184. The system of clause 19, wherein the contact determination circuit is configured to determine the magnitude of the electrical signal.

185. The system of clause 19, wherein the contact determination circuit is configured to determine a signal-to-noise ratio of the electrical signal.

186. The system of clause 19, wherein the contact determination circuit is configured to determine a phase shift or frequency content of the electrical signal.

187. The system of clause 19, wherein the notification circuit is configured to instruct the user to reposition the headset.

188. The system of clause 19, wherein the notification circuit is configured to instruct a user to replace at least a portion of the at least one first electrode.

189. The system of clause 19, wherein the notification circuit is configured to instruct a user to clean at least a portion of the at least one first electrode.

190. The system of clause 19, wherein the notification circuit is configured to instruct the user to wet at least a portion of the at least one first electrode.

191. The system of clause 19, wherein the notification module is configured to instruct the user to apply a gel to at least a portion of the at least one first electrode.

192. The system of clause 19, wherein the notification circuit is configured to deliver a text notification.

193. The system of clause 19, wherein the notification circuit is configured to deliver a visible notification.

194. The system of clause 19, wherein the notification circuit is configured to deliver an audio notification.

195. The system of clause 19, wherein the notification circuit is configured to deliver a directional notification.

196. A personal computing device application for monitoring user usage of a neurostimulation system, comprising:

an audio delivery module adapted to control delivery of an audio signal from an audio signal source via an audio output of the personal computing device to an audio headset having an ear stimulation device associated therewith, the ear stimulation device configured to stimulate nerves innervating the ear of the user;

an emotion assessment module adapted to

Receiving an emotion-related input from the user via a first input structure associated with the personal computing device; and is

Evaluating an emotion of the user based at least in part on the emotion-related input;

a cofactor input module adapted to receive at least one input related to at least one cofactor related to the user through a second input structure associated with the personal computing device;

user control module adapted to

Receiving at least one user control input through a third input structure of the personal computing device, the user control input for controlling a user-controllable stimulation parameter of the ear stimulation device;

a stimulator control module adapted to determine at least one stimulation control parameter based on at least one of the mood of the user, the at least one co-factor, and the at least one user control input; and

a controller interface module for communicating the at least one stimulation control parameter to a stimulator controller adapted to control the ear stimulation device in response to the at least one stimulation control parameter.

197. The personal computing device application of clause 1, wherein the stimulator control module is configured to coordinate delivery of the audio signal with delivery of at least one stimulus with the ear stimulation device.

198. The personal computing device application of clause 1, wherein the audio signal source comprises an audio player application.

199. The personal computing device application of clause 1, wherein the audio signal source comprises a network radio application.

200. The personal computing device application of clause 1, wherein the audio signal source comprises a radio receiver.

201. The personal computing device application of clause 1, wherein the audio signal source comprises a telephone receiver.

202. The personal computing device application of clause 1, wherein the audio signal source comprises a hearing aid.

203. The personal computing device application of clause 1, wherein the emotion assessment module comprises an ecological transient assessment module.

204. The personal computing device application of clause 1, wherein the emotion assessment module comprises an activity assessment module.

205. The personal computing device application of clause 1, wherein the emotion assessment module comprises an image processing module adapted to determine an emotion of the user based on image analysis of an image of the user detected with a user-facing camera of the personal computing device.

206. The personal computing device application of clause 1, wherein the mood assessment module is adapted to receive mood-related input related to depression.

207. The personal computing device application of clause 1, wherein the emotion assessment module is adapted to receive an emotion-related input relating to stress.

208. The personal computing device application of clause 1, wherein the emotion assessment module is adapted to receive emotion-related input related to an emotion.

209. The personal computing device application of clause 1, wherein the mood assessment module is adapted to receive mood-related input related to a mental disorder.

210. The personal computing device application of clause 1, wherein the first input structure of the personal computing device comprises a touch screen, a keyboard, or a microphone.

211. The personal computing device application of clause 1, wherein the auxiliary input structure of the personal computing device comprises at least one of a touch screen, a keyboard, a microphone, a device interface, a data input, a USB port, a wireless interface, a serial port, and a parallel port.

212. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input from the user.

213. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input from a sensor.

214. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input via a computing network.

215. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input relating to an environmental condition of the user.

216. The personal computing device application of clause 20, wherein the environmental condition comprises at least one of a light level, a temperature, a humidity, a pollen count, a noise level, a length of day, precipitation, an air quality measurement.

217. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input relating to a sleep pattern of the user.

218. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input relating to a medical history of the user.

219. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input relating to an activity of the user.

220. The personal computing device application of clause 24, wherein the at least one input related to the user's activity comprises physical activity, health-related activity, entertainment activity, social activity, employment activity, purchasing activity, psychological activity, mental activity, media-related activity, daily living activity, amount of activity, duration of activity, frequency of activity, timing of activity, calendar, schedule, or fee.

221. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input relating to the user's diet.

222. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one input relating to the user's appetite.

223. The personal computing device application of clause 1, wherein the cofactor input module is adapted to receive at least one open comment from the user.

224. The personal computing device application of clause 1, wherein the cofactor input module is adapted to provide a drop-down menu of selectable items, and to receive a selection from the drop-down menu from the user.

225. The personal computing device application of clause 29, wherein the menu of selectable items includes a topical area for discussion with a medical care provider.

226. The personal computing device application of clause 1, comprising: a recommendation delivery module configured to present the recommendation to the user.

227. The personal computing device application of clause 31, wherein the recommendation delivery module is adapted to receive a recommendation from a medical care provider, from an insurance company, a service provider, a consultant, a computing-based system, or a social media resource.

228. The personal computing device application of clause 31, wherein the recommendation delivery module is adapted to receive a recommendation via a computing network.

229. The personal computing device application of clause 31, wherein the recommendation delivery module is adapted to receive recommendations based on patients similar to the user.

230. The personal computing device application of clause 31, wherein the recommendation delivery module is adapted to generate the recommendation.

231. The personal computing device application of clause 35, comprising: a correlation module configured to determine at least one correlation between the mood of the user and at least one of the at least one co-factor and the at least one stimulation control parameter, and wherein the recommendation delivery module is configured to generate the recommendation based at least in part on the at least one correlation.

232. The personal computing device application of clause 35, wherein the recommendation delivery module is adapted to provide the recommendation to the user's medical care provider.

233. The personal computing device application of clause 35, wherein the recommendation delivery module is configured to generate the recommendation based on one of information about the subject's response to past treatment regimens, information obtained via social media, information about at least one preference of at least one social media contact of the subject, information about at least one preference of at least one companion of the subject, information about at least one preference of at least one character model of the subject, information from an insurance company, information from a service provider.

234. The personal computing device application of clause 35, wherein the recommendation delivery module is configured to generate the recommendation using a computing-based system.

235. The personal computing device application of clause 35, wherein the recommendation delivery module is configured to generate the recommendation based on a predicted response of the subject to a treatment regimen.

236. The personal computing device application of clause 31, wherein the recommendation delivery module is configured to receive information regarding whether the subject has accepted or rejected the recommendation.

237. The personal computing device application of clause 31, wherein the recommendation delivery module is configured to present a recommendation of the configuration of neural stimulation to a user.

238. The personal computing device application of clause 31, wherein the recommendation delivery module is configured to present to a user a recommendation of a secondary stimulus delivered in association with the neural stimulus.

239. The personal computing device application of clause 1, which includes a physiological data module adapted to receive at least one physiological data signal representative of at least one physiological parameter of a user.

240. The personal computing device application of clause 44, wherein the physiological data module is adapted to receive at least one physiological data signal from at least one sensor.

241. The personal computing device application of clause 44, wherein the physiological data module is adapted to receive at least one physiological data signal from at least one computing network.

242. The personal computing device application of clause 44, wherein the physiological data module is adapted to receive the at least one physiological data signal from at least one telemetry system.

243. The personal computing device application of clause 44, wherein the physiological data module is adapted to receive the at least one physiological data signal from at least one of a blood pressure sensor, a heart rate sensor, a chemical sensor, a biological sensor, a pH sensor, a blood oxygen sensor, a galvanic skin response sensor, an EEG sensor, an EMG sensor, an ECG sensor, a wearable item, an eye tracking system, an acoustic sensor, a motion sensor, a force sensor, or an activity sensor.

244. The personal computing device application program of clause 1, wherein the user control module is adapted to receive user input for controlling at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope.

245. The personal computing device application of clause 1, wherein the personal computing device comprises a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer.

246. The personal computing device application of clause 1, including a correlation module configured to determine at least one correlation between an emotion of the user and at least one of the at least one cofactor and the at least one stimulus control parameter.

247. The personal computing device application according to clause 1, comprising an external control module configured to receive an external control input for controlling at least one externally controllable stimulation parameter of the ear stimulation device.

248. The personal computing device application of clause 52, wherein the external control module is configured to receive the external control input via a computing network or a communication network.

249. The personal computing device application of clause 52, wherein the external control module is configured to receive external control input from an external party or entity.

250. The personal computing device application of clause 52, wherein the external control module is configured to receive external control input from a healthcare provider.

251. The personal computing device application of clause 52, wherein the at least one externally controllable stimulation parameter comprises at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope.

252. The personal computing device application of clause 1, which includes a data transfer module for providing data relating to a user to an external party or entity.

253. The personal computing device application of clause 57, wherein the data transfer module is configured to provide the data to an external party or entity via a computing network.

254. The personal computing device application of clause 57, wherein the data transfer module is configured to provide the data to an external party or entity via a communications network.

255. The personal computing device application of clause 1, wherein the stimulator control module is configured to determine the at least one stimulation control parameter by overriding the at least one user control input for controlling the at least one user-controllable stimulation parameter based on a healthcare provider control input.

256. The personal computing device application of clause 1, wherein the stimulator control module is configured to override the medical care provider control input based on at least one user control input for controlling at least one user-controllable stimulation parameter.

257. The personal computing device application of clause 1, wherein the stimulator control module is configured to override the at least one user control input for controlling the at least one user-controllable stimulation parameter based on the stimulation control parameter generated by the computing system.

258. The personal computing device application of clause 1, wherein the stimulator control module is configured to override the computing system-generated stimulation control parameters based on at least one user control input for controlling the at least one user-controllable stimulation parameter.

259. The personal computing device application of clause 1, wherein the stimulator control module is configured to determine at least one stimulation control parameter based on the at least one user-controllable stimulation parameter to provide an initial setting of the ear stimulation device.

260. The personal computing device application of clause 1, wherein the stimulator control module is configured to determine the at least one stimulation control parameter based on the at least one user-controllable stimulation parameter to update the settings of the ear stimulation device.

261. A method of controlling an ear stimulation device with a personal computing device, comprising:

receiving, at the personal computing device, an audio signal from an audio signal source;

delivering the audio signal via an audio output of the personal computing device to an audio headset worn by a user, the audio headset having an ear stimulation device associated therewith configured to stimulate nerves innervating the ear of the user;

receiving, with an emotion assessment module, an emotion-related input from the user through a first input structure associated with the personal computing device;

evaluating, with an emotion evaluation module, an emotion of the user based at least in part on the emotion-related input;

receiving, with a cofactor input module, at least one input related to at least one cofactor related to a user through a second input structure associated with the personal computing device;

receiving, with a user control module, at least one user control input for controlling at least one user-controllable stimulation parameter of the ear stimulation device through a third input structure associated with the personal computing device;

determining, with a stimulator control module, at least one stimulation control parameter based on at least one of the mood of the user, the at least one co-factor, and the at least one user control input; and

communicating, with a controller interface module, at least one stimulation control parameter to a stimulator controller adapted to control the ear stimulation device in response to the at least one stimulation control parameter.

262. The method of clause 66, which includes coordinating, with the stimulator control module, delivery of the audio signal and delivery of the at least one stimulus with the ear stimulation device.

263. The method of clause 66, wherein receiving an audio signal at the personal computing device from an audio signal source comprises receiving an audio signal from an audio player application.

264. The method of clause 66, wherein receiving, at the personal computing device, the audio signal from the audio signal source comprises receiving the audio signal from a network radio application.

265. The method of clause 66, wherein receiving, at the personal computing device, the audio signal from the audio signal source comprises receiving the audio signal from a radio receiver.

266. The method of clause 66, wherein receiving an audio signal at the personal computing device from an audio signal source comprises receiving an audio signal from a telephone receiver.

267. The method of clause 66, wherein receiving, at the personal computing device, the audio signal from the audio signal source comprises receiving the audio signal from a hearing aid.

268. The method of clause 66, wherein receiving emotion-related input comprises receiving user input via the eco-transient assessment module.

269. The method of clause 66, wherein receiving the emotion-related input comprises receiving an image of the user with a user-facing camera of the personal computing device, and determining, using image processing software of the emotion assessment module, an emotion of the user based on the image analysis of the image of the user.

270. The method of clause 66, wherein receiving mood-related inputs comprises receiving mood-related inputs related to depression.

271. The method of clause 66, wherein receiving the emotion-related input comprises receiving the emotion-related input relating to stress.

272. The method of clause 66, wherein receiving emotion-related input comprises receiving emotion-related input related to an emotion.

273. The method of clause 66, wherein receiving the emotion-related input via the first input structure comprises receiving at least one input via a touch screen, a keyboard, or a microphone.

274. The method of clause 66, wherein receiving at least one input related to the at least one cofactor comprises receiving at least one input via at least one of a touchscreen, a keyboard, a microphone, a device interface, a data input, a USB port, a wireless interface, a serial port, and a parallel port.

275. The method of clause 66, wherein receiving at least one input related to at least one cofactor related to a user with a cofactor input module comprises receiving at least one input from a user.

276. The method of clause 66, wherein receiving, with the cofactor input module, at least one input related to at least one cofactor related to a user comprises receiving at least one input from a sensor.

277. The method of clause 66, wherein receiving at least one input related to at least one cofactor related to a user with a cofactor input module comprises receiving at least one input via a computing network.

278. The method of clause 66, wherein receiving, with the cofactor input module, at least one input related to at least one cofactor related to the user comprises receiving at least one input related to an environmental condition of the user.

279. The method of clause 83, wherein the environmental condition comprises at least one of a light level, a temperature, a humidity, a pollen count, a noise level, a length of day, precipitation, an air quality measurement.

280. The method of clause 66, wherein receiving at least one input related to at least one cofactor related to a user with a cofactor input module comprises receiving at least one input related to a sleep pattern of the user.

281. The method of clause 66, wherein receiving, with the cofactor input module, at least one input related to at least one cofactor related to a user comprises receiving at least one input related to an activity of the user.

282. The method of clause 86, wherein receiving at least one input related to at least one cofactor related to a user with the cofactor input module comprises receiving at least one input related to physical activity, health-related activity, entertainment activity, social activity, employment activity, purchasing activity, psychological activity, mental activity, media-related activity, activities of daily living, amount of activity, duration of activity, frequency of activity, timing of activity, calendar, schedule, or fee.

283. The method of clause 66, wherein receiving at least one input related to at least one cofactor related to the user with the cofactor input module comprises receiving at least one input related to a diet of the user.

284. The method of clause 66, wherein receiving at least one input related to at least one cofactor related to the user with the cofactor input module includes receiving at least one input related to the appetite of the user.

285. The method of clause 66, wherein receiving at least one input related to at least one cofactor related to a user with a cofactor input module comprises receiving at least one open comment from the user.

286. The method of clause 66, wherein receiving at least one input related to at least one cofactor related to a user with a cofactor input module comprises providing a drop-down menu of selectable items and receiving a selection from the drop-down menu from the user.

287. The method of clause 91, wherein providing a drop down menu of selectable items comprises providing a drop down menu of selectable topical areas for discussion by an external party or entity.

288. The method of clause 66, which includes presenting the recommendation to the user with a recommendation delivery module.

289. The method of clause 93, comprising receiving a recommendation from an external party or entity from an insurance company, service provider, advisor, computing-based system, or social media source.

290. The method of clause 93, comprising receiving a recommendation from a computing network.

291. The method of clause 93, wherein communicating the recommendation to the user comprises communicating the recommendation based on a patient similar to the user.

292. The method of clause 93, which includes generating the recommendation with a recommendation delivery module.

293. The method of clause 97, determining, with a correlation module, at least one correlation between the emotion of the user and at least one of the at least one cofactor and the at least one stimulus control parameter, and generating, with the recommendation delivery module, the recommendation based at least in part on the at least one correlation.

294. The method of clause 93, which includes providing the recommendation to a party or entity external to the user using the recommendation delivery module.

295. The method of clause 97, which includes generating the recommendation based on one of information regarding the subject's response to past treatment regimens, information obtained via social media, information regarding at least one preference of at least one social media contact of the subject, information regarding at least one preference of at least one peer of the subject, information regarding at least one preference of at least one character model of the subject, information from an insurance company, information from a service provider.

296. The method of clause 97, including generating the recommendation using a computing-based system.

297. The method of clause 97, comprising generating the recommendation based on the predicted response of the subject to a treatment regimen.

298. The method of clause 93, which includes receiving, with the recommendation delivery module, information regarding whether the subject has accepted or rejected the recommendation.

299. The method of clause 93, wherein presenting a recommendation comprises presenting a recommendation for a configuration of neural stimulation.

300. The method of clause 93, wherein presenting a recommendation comprises presenting a recommendation of a secondary stimulation delivered in association with the neural stimulation.

301. The method of clause 66, which includes receiving, with a physiological data module, at least one physiological data signal representative of at least one physiological parameter of a user.

302. The method of clause 106, wherein receiving the at least one physiological data signal comprises receiving the at least one physiological data signal from at least one sensor.

303. The method of clause 107, wherein the at least one sensor is located on an audio headset associated with the ear stimulation device.

304. The method of clause 107, wherein the audio headset with the ear stimulation device associated therewith is a first audio headset worn on a first ear of the subject, and wherein the at least one sensor is located on a second audio headset positioned on a second ear of the subject.

305. The method of clause 106, wherein receiving the at least one physiological data signal comprises receiving the at least one physiological data signal from at least one computing network.

306. The method of clause 106, wherein receiving the at least one physiological data signal comprises receiving the at least one physiological data signal from at least one telemetry system.

307. The method of clause 106, wherein receiving the at least one physiological data signal comprises receiving the at least one physiological data signal from at least one of a blood pressure sensor, a heart rate sensor, a chemical sensor, a biological sensor, a pH sensor, a blood oxygen sensor, a galvanic skin response sensor, an EEG sensor, an EMG sensor, an ECG sensor, a wearable item, an eye tracking system, an acoustic sensor, a motion sensor, a force sensor, or an activity sensor.

308. The method of clause 66, wherein receiving the at least one user control input for controlling the at least one user-controllable stimulation parameter comprises receiving at least one user input for controlling at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope.

309. The method of clause 66, wherein the personal computing device comprises a phone, a watch, a wearable device, a tablet computer, a laptop computer, or a desktop computer.

310. The method of clause 66, which includes determining, with a correlation module, at least one correlation between the mood of the user and at least one of the at least one cofactor and the at least one stimulus control parameter.

311. The method of clause 66, which includes receiving, with an external control module, an external control input for controlling at least one externally controllable stimulation parameter of the ear stimulation device.

312. The method of clause 116, which includes receiving an external control input with an external control module via a computing network or a communications network.

313. The method of clause 116, which includes receiving an external control input from an external party or entity.

314. The method of clause 116, which includes an external control input from a medical care provider.

315. The method of clause 116, wherein the at least one externally controllable stimulation parameter comprises at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope.

316. The method of clause 66, which includes providing data relating to the user to an external party or entity.

317. The method of clause 121, wherein providing the data to the external party or entity comprises providing the data via a computing network.

318. The method of clause 121, wherein providing the data to the external party or entity comprises providing the data via a communication network.

319. The method of clause 121, wherein providing the data to the external party or entity comprises providing the data to a medical services provider.

320. The method of clause 66, wherein determining the at least one stimulation control parameter comprises: overriding the at least one user control input for controlling the at least one user-controllable stimulation parameter based on a medical care provider control input.

321. The method of clause 66, wherein determining the at least one stimulation control parameter comprises overriding a healthcare provider control input based on the at least one user control input for controlling the at least one user-controllable stimulation parameter.

322. The method of clause 66, wherein determining the at least one stimulation control parameter comprises overriding the at least one user control input for controlling the at least one user-controllable stimulation parameter based on a computing system generated stimulation control parameter.

323. The method of clause 66, wherein determining the at least one stimulation control parameter comprises overriding a computing system-generated stimulation control parameter based on the at least one user control input for controlling the at least one user-controllable stimulation parameter.

324. The method of clause 66, wherein determining the at least one stimulation control parameter comprises determining an initial setting of the ear stimulation device based on the at least one user-controllable stimulation parameter.

325. The method of clause 66, wherein determining the at least one stimulation control parameter comprises updating a setting of the ear stimulation device based on the at least one user-controllable stimulation parameter.

The subject matter described herein sometimes illustrates different components included in or connected to different other components. It is to be understood that such depicted architectures are merely exemplary, and that in fact many other architectures can be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively "associated" such that the desired functionality is achieved. Hence, any two components herein combined to achieve a particular functionality can be seen as "associated with" each other such that the desired functionality is achieved, irrespective of architectures or intermedial components. Likewise, any two components so associated can also be viewed as being "operably connected," or "operably coupled," to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being "operably couplable," to each other to achieve the desired functionality. Specific examples of operably couplable include, but are not limited to: physically mateable and/or physically interacting components; and/or components that are interactable by wireless means and/or interact by wireless means; and/or components that interact logically and/or can interact logically, etc.

In some cases, one or more components may be referred to herein as "configured," "configurable," "operatively/operatively to," "adapted/adaptable," "able," "adaptable/adapted," and the like. One of ordinary skill in the art will recognize that these terms (e.g., "configured to") may generally include active state components and/or inactive state components and/or standby state components unless the context requires otherwise.

As described herein, the personal computing device may include circuitry and other hardware components, for example, provided in the form of a custom board that is installed in the housing of the personal computing device during or after manufacture, or provided in a separate package that can be operatively connected to the personal computing device through one or more wired and/or wireless connections. Unless the context dictates otherwise, as used herein, the term personal computing device is intended to encompass a system comprising circuitry and other hardware components packaged with the personal computing device and circuitry, as well as circuitry and other hardware components packaged separately but used in combination with the personal computing device.

While particular aspects of the present subject matter described herein have been shown and described, it will be obvious to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from the described subject matter and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the true spirit and scope of the subject matter described herein. It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" is interpreted as "including but not limited to," the term "having" is interpreted as "having at least," the term "includes" is interpreted as "includes but is not limited to," etc.). If a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation object by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation object to claims containing only one such recitation object, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Moreover, in those instances where a convention analogous to "A, B, at least one of C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand (e.g., "a system having at least one of A, B and C" would include but not be limited to systems having A only, B only, C only, A and B together, A and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand (e.g., "a system having at least one of A, B or C" would include but not be limited to systems having A only, B only, C only, A and B together, A and C together, B and C together, and/or A, B and C together, etc.). It will be further understood by those within the art that, in general, terms and/or phrases providing two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibilities of including one, either, or both of the terms, unless context dictates otherwise. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".

With respect to the appended claims, those skilled in the art will appreciate that the operations recited therein may generally be performed in any order. Further, while the various operational flows are presented in a sequence(s), it should be understood that the various operations may be performed in an order different than that shown, or may be performed concurrently. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, complementary, simultaneous, reverse, or other variant orderings, unless context dictates otherwise. Furthermore, terms such as "responsive to," "associated with," or other past tense adjectives are generally not intended to exclude such variants, unless the context dictates otherwise.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Claims (50)

1.A neurostimulation headset, comprising:

an ear canal insert adapted to fit into an ear canal of a human subject, the ear canal insert comprising

At least one first electrode configured to electrically contact skin within the ear canal of the subject;

an outer ear insert adapted to fit within the outer ear of the subject, the outer ear insert comprising

A base configured to fit within a cavity of the outer ear of the subject;

a wing configured to fit within a boat of the outer ear of the subject; and

at least one second electrode configured to electrically contact at least a portion of the outer ear of the subject;

at least one first electrical connector for connecting the at least one first electrode on the ear canal insert to a first current source; and

at least one second electrical connector for connecting said at least one second electrode on said outer ear insert to a second current source.

2. The neurostimulation earpiece of claim 1, wherein the ear canal insert comprises a sound delivery portion adapted to deliver sound to the ear canal of the subject.

3. The neurostimulation headset of claim 1, further comprising a wireless communication circuit adapted for transmitting data signals, receiving audio signals, or receiving audio signals.

4. The neurostimulation headset of claim 3, wherein the wireless communication circuitry comprises Bluetooth communication circuitry.

5. The neurostimulation earpiece of claim 2, wherein the sound delivery portion comprises a passageway through the ear canal insert such that sound can be delivered through the ear canal insert to the ear canal of the subject.

6. A neurostimulation system comprising the neurostimulation headset of any of claims 1-5, further comprising:

an ear stimulation device controller comprising

A first analog output connector adapted to connect a first current signal to at least one first electrode of the neurostimulation headset;

a second analog output connector adapted to connect a second current signal to the at least one second electrode of the neurostimulation headset;

a wireless microcontroller configured to control wireless communication between the ear stimulation device controller and a personal computing device to receive one or more stimulation parameters from the personal computing device;

a digital stimulation signal generator configured to generate a digital stimulation signal based at least in part on the one or more stimulation parameters received from the personal computing device;

a digital-to-analog converter for converting the digital stimulation signal to an analog voltage waveform;

a current driver operably connected to the digital-to-analog converter and adapted to generate a controlled current stimulation waveform in response to the analog voltage waveform, wherein the controlled current stimulation waveform is provided to the ear stimulation device via at least the first and second analog output connectors; and

a power source operably connected to at least one of the wireless microcontroller, the digital stimulation signal generator, the digital-to-analog converter, and the current driver.

7. An ear stimulation device controller, comprising:

a first analog output connector adapted to connect a first current signal to a first electrode of an ear canal insert of an ear stimulation device;

a second analog output connector adapted to connect a second current signal to a second electrode of an outer ear insert of the ear stimulation device;

a wireless microcontroller configured to control wireless communication between the ear stimulation device controller and a personal computing device to receive one or more stimulation parameters from the personal computing device;

a digital stimulation signal generator configured to generate a digital stimulation signal based at least in part on the one or more stimulation parameters received from the personal computing device;

a digital-to-analog converter for converting the digital stimulation signal to an analog voltage waveform;

a current driver operably connected to the digital-to-analog converter and adapted to generate a controlled current stimulation waveform in response to the analog voltage waveform, wherein the controlled current stimulation waveform is provided to the ear stimulation device via at least the first and second analog output connectors; and

a power source operably connected to at least one of the wireless microcontroller, the digital stimulation signal generator, the digital-to-analog converter, and the current driver.

8. An ear stimulation device controller according to claim 7, further comprising a physiological signal input adapted to receive a physiological signal.

9. An ear stimulation device controller according to claim 8, wherein the first and second analogue output connectors are configured to be connected to the ear stimulation device located on a first ear of the user, and wherein the physiological signal input is configured to receive the physiological signal from a physiological sensor located on a second ear of the user.

10. A method of controlling an ear stimulation device with a personal computing device, comprising:

capturing, with an image capture circuit on the personal computing device, an image of a user of the personal computing device through a user-facing camera associated with the personal computing device;

processing the image using image processing circuitry on the personal computing device to determine at least one parameter; and

controlling, with a neural stimulation control signal determination circuit on the personal computing device, delivery of stimulation to at least one nerve innervating an ear of the user with the ear stimulation device based at least in part on the at least one parameter.

11. The method of claim 10, wherein the image processing circuitry comprises application software on the personal computing device.

12. The method of claim 10, wherein the at least one parameter represents at least one of an emotion of the user, a physiological condition of the user, a medical condition of the user, an identity of the user, a heart rate of the user, an eye position of the user, an eye movement of the user, or a position of an earpiece of the ear stimulation device relative to the ear of the user.

13. The method of claim 12, comprising delivering a notification to the user under control of a notification circuit on the personal computing device announcing the user's need to adjust the position of the headset relative to the ear of the user.

14. The method of claim 10, comprising:

processing the image using the image processing circuit to determine

The presence of at least one earpiece of the ear stimulation device positioned at the user's ear;

an ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and

at least one attribute of the at least one earpiece representative of the at least one earpiece's usability for one of the left or right ear of the user;

determining, using application software on the personal computing device, an ear that can use the headset based on the at least one attribute of the at least one headset;

determining, using application software on the personal computing device, whether the ear in which the at least one earpiece is located is the ear in which the earpiece is available; and is

If the ear in which the at least one earpiece is located is not the ear in which the earpiece is available, sending a control signal from the personal computing device to the ear stimulation device under control of the neurostimulation control signal determination circuitry to prevent delivery of stimulation through the earpiece to the ear in which the earpiece is located.

15. The method of claim 14, comprising receiving, with a handshaking circuit on the personal computing device, a handshaking signal from an ear stimulation device control circuit associated with the ear stimulation device.

16. The method of claim 15, comprising at least one of: capturing the image of the user of the personal computing device in response to receiving the handshaking signals from the ear stimulation device control circuitry and sending a handshaking signal to the ear stimulation device control circuitry in response to determining the presence of the at least one earpiece located at the ear of the user in the image.

17. The method of claim 14, comprising sending a notification to the user under control of a notification circuit on the personal computing device announcing the user's need to switch the headset to another ear if the ear in which the at least one headset is located is not the ear with which the headset is available.

18. An ear stimulation device control system, comprising:

a personal computing device;

a user-facing camera associated with the personal computing device;

an image capture circuit adapted to capture an image of a user of the personal computing device from the user-facing camera;

an image processing circuit configured to process the image to determine at least one parameter; and

a neural stimulation control signal determination circuit configured to control delivery of stimulation with an ear stimulation device to at least one nerve innervating an ear of the user based at least in part on the at least one parameter.

19. The system of claim 18, wherein the image processing circuitry comprises a headphone location module configured to process the image to determine

The presence of at least one earpiece of the ear stimulation device located at the user's ear;

an ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and

at least one attribute of the at least one earpiece representative of the at least one earpiece's usability for one of the left or right ear of the user; and is

Wherein the neural stimulation control signal determination circuit is configured to

Determining an ear that can use the headset based on the at least one attribute of the at least one headset;

determining whether the ear in which the at least one earphone is located is the ear in which the earphone can be used; and is

Sending a control signal from the personal computing device to the ear stimulation device to prevent the stimulus from being delivered to the at least one nerve innervating the ear of the user if the ear in which the at least one earpiece is located is not the ear in which the earpiece is usable.

20. A method of controlling an ear stimulation device with a personal computing device, comprising:

detecting, at an electrical signal input circuit, an electrical signal representative of electrical contact of at least one first electrode with an ear of a user of a personal computing device via at least one first electrode of an earpiece of an ear stimulation device, wherein the at least one ear is operatively connected to the personal computing device, and wherein the ear stimulation device is adapted to stimulate at least one nerve innervating the ear of the user of the personal computing device;

determining, using contact determination circuitry on the personal computing device, whether the at least one first electrode is in good electrical contact with the ear of the user;

if the at least one first electrode is not in good electrical contact with the ear of the user, sending a control signal from the personal computing device to the ear stimulation device under control of a neurostimulation control signal determination circuit on the personal computing device to prevent delivery of stimulation through the headphones to the ear in which the headphones are located; and

communicating a notification to the user regarding the state of the at least one first electrode under control of a notification circuit on the personal computing device.

21. The method of claim 20, comprising delivering an electrical test signal via at least one second electrode of the at least one earpiece under control of a test signal circuit on the personal computing device, and detecting the electrical signal via the at least one first electrode in response to the electrical test signal.

22. The method of claim 20, wherein delivering the notification to the user comprises at least one of instructing the user to reposition the headset, instructing the user to replace at least a portion of the at least one first electrode, instructing the user to clean at least a portion of the at least one first electrode, instructing the user to wet at least a portion of the at least one first electrode, instructing the user to apply a gel to at least a portion of the at least one first electrode, delivering a textual notification, delivering a visual notification, delivering an audio notification, and delivering a directional notification.

23. An ear stimulation device control system, comprising:

a personal computing device configured to control delivery to at least one nerve innervating an ear of a user of the personal computing device via an ear stimulation device, the ear stimulation device comprising an earpiece including at least one first electrode, the personal computing device comprising

An electrical signal input circuit adapted to receive an electrical signal representative of electrical contact of the at least one first electrode with the ear of a user of the personal computing device;

a contact determination circuit configured to determine whether the at least one first electrode is in good electrical contact with the ear of the user;

a neural stimulation control signal determination circuit configured to send a control signal from the personal computing device to the ear stimulation device to prevent delivery of the stimulation if the at least one first electrode is not in good electrical contact with the ear of the user; and

a notification circuit configured to deliver a notification to the user regarding the state of the at least one first electrode.

24. The system of claim 23, comprising a handshaking circuit adapted to receive a handshaking signal from an ear stimulation device control circuit associated with the ear stimulation device.

25. The system of claim 23, comprising a test signal circuit configured to deliver an electrical test signal via at least one second electrode of the at least one ear stimulation device and to detect the electrical signal via the at least one first electrode in response to the electrical test signal.

26. A personal computing device application for monitoring user usage of a neurostimulation system, comprising:

an audio delivery module adapted to control delivery of an audio signal from an audio signal source via an audio output of the personal computing device to an audio headset having an ear stimulation device associated therewith, the ear stimulation device configured to stimulate nerves innervating an ear of the user;

an emotion assessment module adapted to

Receiving an emotion-related input from the user via a first input structure associated with the personal computing device; and is

Evaluating an emotion of the user based at least in part on the emotion-related input;

a cofactor input module adapted to receive at least one input related to a cofactor related to the user through a second input structure associated with the personal computing device;

user control module adapted to

Receiving at least one user control input through a third input structure of the personal computing device, the user control input for controlling a user-controllable stimulation parameter of the ear stimulation device;

a stimulator control module adapted to determine at least one stimulation control parameter based on at least one of the mood of the user, the at least one co-factor, and the at least one user control input; and

a controller interface module for communicating the at least one stimulation control parameter to a stimulator controller adapted to control the ear stimulation device in response to the at least one stimulation control parameter.

27. The personal computing device application of claim 26, wherein the emotion assessment module comprises at least one of an eco-transient assessment module, an activity assessment module, an image processing module adapted to determine an emotion of the user based on image analysis of an image of the user detected with a user-facing camera of the personal computing device.

28. The personal computing device application of claim 26, wherein the cofactor input module is adapted to receive at least one input from at least one of the user, a sensor, and a computing network.

29. The personal computing device application of claim 26, wherein the cofactor input module is adapted to at least one of receive at least one open comment from the user and provide a drop-down menu of selectable items and receive a selection from the drop-down menu from the user.

30. The personal computing device application of claim 26, comprising:

a recommendation delivery module configured to present recommendations to the user.

31. The personal computing device application of claim 26, comprising a physiological data module adapted to receive at least one physiological data signal representative of at least one physiological parameter of the user.

32. The personal computing device application of claim 26, comprising: a correlation module configured to determine at least one correlation between the emotion of the user and at least one of the at least one co-factor and the at least one stimulation control parameter.

33. The personal computing device application of claim 26, comprising an external control module configured to receive an external control input for controlling at least one externally controllable stimulation parameter of the ear stimulation device.

34. The personal computing device application of claim 26, comprising a data transfer module for providing data relating to the user to an external party or entity.

35. A method of controlling an ear stimulation device with a personal computing device, comprising:

receiving, at the personal computing device, an audio signal from an audio signal source;

delivering the audio signal via an audio output of the personal computing device to an audio headset worn by a user, the audio headset having an ear stimulation device associated therewith configured to stimulate nerves innervating an ear of the user;

receiving, with an emotion assessment module, an emotion-related input from the user through a first input structure associated with the personal computing device;

evaluating, with an emotion evaluation module, an emotion of the user based at least in part on the emotion-related input;

receiving, with a cofactor input module, at least one input related to at least one cofactor related to the user through a second input structure associated with the personal computing device;

receiving, with a user control module, at least one user control input for controlling at least one user-controllable stimulation parameter of the ear stimulation device through a third input structure associated with the personal computing device;

determining, with a stimulator control module, at least one stimulation control parameter based on at least one of the mood of the user, the at least one co-factor, and the at least one user control input; and

communicating, with a controller interface module, at least one stimulation control parameter to a stimulator controller adapted to control the ear stimulation device in response to the at least one stimulation control parameter.

36. The method of claim 35, comprising coordinating delivery of the audio signal with delivery of at least one stimulus with the ear stimulation device with the stimulator control module.

37. The method of claim 35, wherein receiving the audio signal at the personal computing device from the audio signal source comprises receiving the audio signal from at least one of an audio player application, a network radio application, a radio receiver, a telephone receiver, and a hearing aid.

38. The method of claim 35, wherein receiving the emotion-related input comprises at least one of: receiving user input via an ecological transient assessment module; receiving an image of the user with a user-facing camera of the personal computing device and determining an emotion of the user based on image analysis of the image of the user with image processing software of the emotion assessment module; receiving mood-related input related to depression; receiving an emotion-related input related to stress; receiving emotion-related input related to an emotion; and receiving at least one input via a touch screen, a keyboard, or a microphone.

39. The method of claim 35, wherein receiving the at least one input related to the at least one cofactor comprises at least one of: receiving at least one input via at least one of a touch screen, a keyboard, a microphone, a device interface, a data input, a USB port, a wireless interface, a serial port, and a parallel port; receiving at least one input from the user; receiving at least one input from a sensor; receiving at least one input via a computing network; receiving at least one input relating to an environmental condition of the user; receiving at least one input relating to a sleep mode of the user; receiving at least one input related to an activity of the user; receiving at least one input relating to a physical activity, a health-related activity, an entertainment activity, a social activity, a employment activity, a purchasing activity, a mental activity, a media-related activity, an activity of daily living, an activity amount, an activity duration, an activity frequency, an activity timing, a calendar, a schedule, or a fee; receiving at least one input relating to the user's diet; receiving at least one input relating to the user's appetite; receiving at least one open comment from the user; and providing a drop down menu of selectable items and receiving a selection from the drop down menu from the user.

40. The method of claim 35, comprising presenting recommendations to the user with a recommendation delivery module.

41. The method of claim 40, comprising at least one of: receiving recommendations from an external party or entity from an insurance company, service provider, advisor, computing-based system, social media source, or computing network; providing the recommendation to a party or entity external to the user using the recommendation delivery module; and receiving, with the recommendation delivery module, information regarding whether the subject has received or rejected the recommendation.

42. The method of claim 40, comprising generating the recommendation with the recommendation delivery module.

43. The method of claim 42, comprising at least one of: determining, with a correlation module, at least one correlation between the emotion of the user and at least one of the at least one co-factor and the at least one stimulus control parameter, and generating, with the recommendation delivery module, the recommendation based at least in part on the at least one correlation; generating the recommendation based on one of information about the subject's response to past treatment regimens, information obtained via social media, information about at least one preference of at least one social media contact of the subject, information about at least one preference of at least one companion of the subject, information about at least one preference of at least one role model of the subject, information from an insurance company, information from a service provider; generating the recommendation using a computing-based system; and generating the recommendation based on the predicted response of the subject to the treatment regimen.

44. The method of claim 40, wherein presenting the recommendation comprises at least one of: presenting a recommendation for a configuration of the neural stimulation; and presenting a recommendation for the auxiliary stimulus to be delivered in relation to the neural stimulus.

45. The method of claim 35, comprising receiving at least one physiological data signal representative of at least one physiological parameter of the user with a physiological data module.

46. The method of claim 35, wherein receiving the at least one user control input for controlling the at least one user controllable stimulation parameter comprises receiving at least one user input for controlling at least one of stimulation pulse amplitude, stimulation pulse duration, stimulation frequency, stimulation pulse pattern, and stimulation pulse envelope.

47. The method of claim 35, comprising determining, with a correlation module, at least one correlation between the emotion of the user and at least one of the at least one co-factor and the at least one stimulation control parameter.

48. The method according to claim 35, comprising receiving, with an external control module, an external control input for controlling at least one externally controllable stimulation parameter of the ear stimulation device.

49. The method according to claim 48, wherein the at least one externally controllable stimulation parameter includes at least one of a stimulation pulse amplitude, a stimulation pulse duration, a stimulation frequency, a stimulation pulse pattern, and a stimulation pulse envelope.

50. The method according to claim 35, wherein determining the at least one stimulation control parameter comprises at least one of: overriding the at least one user control input for controlling the at least one user-controllable stimulation parameter based on a medical care provider control input; overriding a healthcare provider control input based on the at least one user control input for controlling the at least one user-controllable stimulation parameter; overriding at least one user control input for controlling the at least one user-controllable stimulation parameter based on a stimulation control parameter generated by a computing system; override the computing system generated stimulation control parameter based on the at least one user control input for controlling the at least one user controllable stimulation parameter; determining an initial setting of the ear stimulation device based on the at least one user-controllable stimulation parameter; and updating settings of the ear stimulation device based on the at least one user-controllable stimulation parameter.