INTRODUCTION

Hearing aids are the principal means of auditory rehabilitation for patients with sensorineural hearing loss (SNHL). Hearing
aids may also play a role in the management of conductive hearing losses (CHLs) that are not amenable to medical or
surgical treat- ment. Continued improvements in signal processing capabilities and increasing miniaturization of hearing aids
have increased their acceptance among patients. Despite these advances, hearing aids remain a “tough sell” to many who
could potentially benefit from them, due to a lack of perceived benefit, expense, and cosmetic concerns. Many others simply
cannot wear a hearing aid due to complications of external auditory canal occlusion, such as chronic infections or extreme
discomfort. Anatomic abnormalities such as microtia, atresia, or a prior meatoplasty also can prevent

conventional hearing aid use. Although newer hearing aid technolo- gies have tried to address many of these difficulties,
many patients still find that they fall short in meeting expectations in a variety of situations (Box 159.1). It is partly for these
1
reasons that less than only one in five eligible adults actually use a hearing aid.

These inherent limitations in hearing aids, combined with the social stigma of their use, have led to the development of
implant- able hearing devices (Figs. 159.1 and 159.2). Implantable hearing devices offer several potential advantages over
conventional hearing aids. These include increased gain and dynamic range, reduced feedback, reduced maintenance,
improved appearance, and freedom from ear canal occlusion. Of course, these potential benefits must be weighed against the
risk of surgical implantation, difficulty of maintenance, and increased initial device cost (Table 159.1). Complicating this
risk-benefit calculation is the uncertain future of some relatively small corporations marketing and supporting various
implantable hearing devices.

Prior to discussing each of the implantable hearing devices currently available or in development, it is important to review in
more detail why there is a desire for their implementation in the first place.

LIMITATIONS OF AUDITORY REHABILITATION USING TRADITIONAL

HEARING AIDS

Physical Factors

Traditional hearing aids are limited in their ability to amplify sound without imparting distortion or generating feedback, in
part because these aspects of performance are physically interrelated. The following are physical factors limiting traditional
hearing aids’ ability to successfully amplify sound in an acceptable manner for patients with hearing loss.

Insufficient Gain

For patients with severe to profound hearing loss, sound amplifica- tion (or gain) is a primary concern. For a patient with air
conduction thresholds of 80 dB SHL to perceive quiet sounds at a normal threshold of 0 dB SHL, a hearing aid must amplify
sound intensity by 80 dB, generating a 10,000-fold increase in sound pressure wave amplitude and a 100,000,000-fold
2
increase in sound power intensity. This represents the limit of existing traditional hearing aids. For example, the maximum
3
amplification at 1 kHz for a behind-the-ear (BTE) Phonak SuperFront PPCL4 power digital aid is about 75 to 82 dB. Gain
generally scales with hearing aid size, so that cosmetically less obtrusive aids offer less gain. The maximum gains for digital
in-the-ear (ITE), in-the-canal (ITC), and completely-in-canal (CIC) aids currently are about 55 to 65 dB, 45 to 55 dB, and 35
3
to 50 dB, respectively.

Acoustic Feedback

In practice, feedback often limits the useful gain of traditional hearing aids to less than the maximum gains listed previously.

2396

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Abstract

Background

Current conventional hearing aids have several limitations, which limit their effectiveness for many patients. These
limitations have led to the pursuit of new methods of hearing amplification that have included both active middle ear
implants, as well osseointe- grated bone conduction hearing prothesis. The goal of this chapter is to describe clinical settings
in which implantable hearing devices can overcome the limitations of hearing aids, and to provide up-to-date information on
both active middle ear implants and bone-conducting hearing prosthesis.

Methods

Review of the literature on both active middle ear implants and bone-conducting prosthesis.

Results

There are multiple different manufacturers pursing active middle ear implants. All consist of a transducer that is coupled to
either to ossicular chain or round to drive the acoustic input to the cochlea. Although they have seen limited use in the United
States due to financial and insurance constraints, they have had widespread application abroad. By driving the ossicular
chain, these devices hope to be able to provide a higher and more selective gain than conventional hearing aids, and early
results have been promising.

Osseointegrated prosthesis function by directly stimulating the cochlea via vibrations of the skull. They have excellent
outcomes in individuals with conductive hearing loss who are unable to have surgical repair of the ossicular chain. For
individuals with single- sided deafness, they have been shown to improve understanding speech in noise, but not sound
localization.

Conclusion

Both active middle ear implants and bone-conducting implants are useful tools in helping to rehabilitate patients with hearing
loss.

Keywords

Implantable hearing devices osseointegrated bone-conducting prosthesis bone-anchored hearing aids

middle ear implants
implantable hearing aids
hearing rehabilitation

CHAPTER 159 Implantable Hearing Devices2396.e1

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159
Acoustic waves from the hearing aid speaker leak through the air space between the hearing aid body and the external
auditory canal wall back to the microphone, where (for a subset of frequen- cies) they add to existing microphone input and
are amplified further. The resulting positive feedback loop causes the familiar squealing and hum that signify a poorly fitting
or over amplified aid. Potential for feedback is worst for CIC aids, in which the microphone is closest to the speaker, and for
ears with mastoid bowls, in which an air seal is difficult to obtain. At very high amplification, it is a problem even for BTE
aids. Fitting aids tightly into the external auditory canal can decrease feedback, but at the cost of increased discomfort,
autophony, blockage of natural sound input, and the risk of otitis externa.

Distortion of Spectral Shape and Phase Shifts

Traditional hearing aids are limited in the frequency range over which they amplify sound. Most are optimized for
performance in the speech band (500 to 2000 Hz) and cannot provide much amplification below 100 to 200 Hz or above 5000
to 6000 Hz. Although the most important spectral components for speech recognition are amplified, the loss of “bass” and
“treble” can give the resultant sound percept an artificial character. Isolated severe hearing loss at low frequencies (as in
Ménière’s) or high frequencies

(such as in presbycusis or ototoxic exposure) can be difficult to remediate with traditional aids without overamplifying the
midrange frequencies at which a patient may have normal hearing. Even in the 500 to 2000 Hz band, steep changes in
audiometric threshold at neighboring frequencies (e.g., noise-induced hearing loss) cannot be perfectly fit due to inherent
limitations in the rate of change of gain across frequencies. Too steep a change in amplifier gain across frequencies typically
imparts phase shifts that distort sound percepts such as pitch and timbre. Digital signal processing technology has greatly
improved spectral shaping options compared with analog aids, but these fundamental limitations persist.

Nonlinear Distortion

Similar to most other amplifiers, hearing aids are designed under assumption of linearity—that is, if a given sound input at
the microphone is doubled, then the output at the speaker (amplified and spectrally shaped by the aid) should also be exactly
doubled, without changes in spectral content or phase shifts. For high- intensity speaker output, this assumption breaks down
as the speaker is driven into a range for which it begins to saturate or clip. An input sinusoid can appear at the output as a
waveform with blunted peaks. This nonlinear distortion imparts aberrant spectral com- ponents into the sound percept, giving
it an artificial or robotic character. Although digital signal processing can mitigate distortion effects within an aid’s
amplification circuitry, distortion produced by a speaker generating loud sounds in air remain a fundamental limitation of
traditional hearing aids.

Occlusion Effects

To minimize feedback, most traditional hearing aids are fit to create an air-tight seal with the external auditory canal wall,
with the hearing aid’s speaker being isolated in the occluded ear canal. Canal occlusion has several undesirable effects. First,
it can be uncomfortable due to pressure on canal skin. Second, it increases the likelihood of otitis externa due to disturbance
of wax egress

CHAPTER 159 Implantable Hearing Devices 2397

BOX 159.1 Nonideal Features of Conventional Hearing Aids

Insufficient amplification
Acoustic feedback
Spectral distortion Nonlinear/harmonic distortion Occlusion of external auditory canal Appearance/visibility

Lack of directionality

Osseointegrated

bone-conducting hearing prosthesis

Conventional hearing aid

Implantable middle ear hearing device

Cochlear implant

Dental appliance–based bone-conduction system

Fig. 159.1 Overview of how various implantable hearing devices interface with the auditory system. Conventional aids amplify from within
the canal, whereas osseointegrated bone-conducting hearing prostheses are applied to the retroauricular skull to provide hearing via bone
conduction. Similarly, dental appliance–based bone-conduction systems also provide hearing. Implantable middle ear hearing devices
interface at the level of the ossicles and bypass the eardrum. In contrast, cochlear implants directly stimulate the remaining neural elements
within the cochlea. (Courtesy Nikolas Blevins, MD.)

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159

Microphone Amplifier Speaker

Malleus Malleus

Malleus

Malleus

Amplifier

Stapes Stapes

Stapes

Stapes

Stapes
Cochlea Cochlea

Cochlea

Cochlea

Cochlea

Microphone

Amplifier

Piezo- electric actuator

Piezo- electric sensor

Piezo- electric actuator

Microphone

Amplifier

Magnetic field generator

Malleus

Magnet

Microphone

Amplifier

Skull or tooth vibrator

2398 PART VII

Otology, Neurotology, and Skull Base Surgery

 1. A Sound in air
2. B Sound in air
3. C Sound in air
4. D Sound in air
5. E Sound in air

Sound in EAC air

TM Incus TM Incus

TM
TM Incus

TM Incus
Fig. 159.2 Sound transduction and coupling to the auditory system for different classes of hearing aids.
(A) Conventional air-conducting hearing aid. (B) Implantable aids with piezoelectric actuator. (C) Implantable aids with piezoelectric sensor
and actuator. (D) Implantable aids with magnetic actuator. (E) Osseointegrated or dental bone-conducting hearing prostheses. EAC, External
auditory canal; TM, tympanic membrane.
and air circulation. Some patients with chronic suppurative otitis media cannot tolerate hearing aids due to exacerbation of
otorrhea. Third, it causes autophony and a sense of aural fullness that can worsen with changes in ambient barometric
pressure. Fourth, it blocks the normal pathway for sound entry to the ear. Finally, it disrupts the spectral shaping that
normally occurs due to external auditory canal’s natural resonance.

Poor Appearance

Many patients reject hearing aids due to the social stigma of being seen as old or infirm. Even the 8% of hearing aid
candidates wearing the less noticeable ITC hearing aids listed poor cosmetic appearance as a major contributing factor in
4
their decision not to use a hearing aid. Hearing aids are difficult to conceal in patients who are balding or who wear their hair
short. Miniaturization of electronics continues to improve hearing aids in this regard, and CIC hearing aids are essentially
invisible to the casual observer. Newer, open ear (OE) styles of hearing aids use miniaturized behind the ear processors and a
clear tube to direct sound into the ear canal without the need for occlusion. These OE styles are nearly as inconspicuous as
5
CIC models during typical communication positions. However, oftentimes, miniaturization comes at the cost of lower gain,
more feedback, and higher cost. Ultimately, battery size becomes the limiting factor, with smaller batteries costing more and
requiring more frequent replacement or charging.

Poor Transduction Efficiency

Loss of energy due to impedance mismatching and transduction losses is another inherent drawback of conventional aids.
The mechanical impedance (change in pressure for a given displacement flow) of the air-filled external auditory canal differs
from that of the fluid-filled cochlea. Without a middle ear mechanism, a majority of the acoustic energy striking the stapes
footplate reflects back into the air. When the tympanic membrane and ossicular chain

are functioning normally, they act as an impedance-matching transformer by virtue of the relative areas of the tympanic
6
mem- brane and stapes footplate, and by the lever action of the ossicular chain. The relatively large-displacement, low-
pressure movements of air against the tympanic membrane are transduced to the relatively small-displacement, high-pressure
movements of the footplate. Except for bone-conducting devices, all traditional hearing aids use a speaker to output an
(amplified) acoustic wave into the air of the external auditory canal. When this middle ear apparatus is malfunctioning, as
occurs in otosclerosis, tympanic membrane perforation, or in a canal-wall down mastoidectomy, traditional hearing aids must
overcome the impedance mismatch. The result is either reduced effective gain, increased distortion, or both.

Even when the ossicular chain is functioning normally, the transduction of acoustic energy from air at the input of a
traditional hearing aid to stapes footplate motion is imperfect. Whenever a signal flows from one physical realm (e.g.,
electrical current in a speaker) to another (e.g., acoustic waves in air), some energy is lost (e.g., to heat) and noise or
distortion can add to the desired signal. There are several transduction steps for a traditional hearing aid—from acoustic
waves in ambient air, to electrical current in a microphone, to a larger electrical current in a speaker wire or piezoelectric
driver, to acoustic waves in air within the external auditory canal, to movement of the tympanic membrane and ossicular
chain, to acoustic waves in perilymph, to hair cell stereocili- ary deflection and depolarization, and so forth. Most are
unavoidable (although cochlear implants bypass these steps through direct cochlear nerve stimulation). However, directly
coupling a hearing device actuator to the ossicular chain can remove some of these transduction steps, boosting gain and
reducing distortion. Nearly all implantable hearing devices make use of this approach.

Human Factors

Although not specific to traditional hearing aids, SNHL imposes additional constraints on the degree to which sound
amplification can overcome hearing deficits. These factors must be considered

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CHAPTER 159 Implantable Hearing Devices 2399

TABLE Totally/ Convent Convent Esteem Carina Vibrant Baha Ponto Alpha 2 Bonebridge SoundBi BTE,
159.1 Regulator ional ional (Envoy (Cochlear External (Cochlear) (Oticon (Sophono) External te Behind
Compari y digital digital Piezoelec) BTE External External External Electromag (Sonitus the ear;
son of Partially External External tric, Electromag Electroma Electroma Electromag netic External CE,
Convent Surgical BTE CIC Medical) netic, gnetic gnetic netic vibrator, BTE Commun
Subcutan
ional Audiologi Acoustic device coupled clipped to vibrator, vibrator, vibrator, (Med-El) Piezoele auté
eous
Hearing c Special , to TM microph to FDA microphon Medical) microphon microphon ctric, to Européen
micropho
Aids and Advantag Yes NA one at Partial e coupled microphon e e maxillar ne; CHL,
ne
Implanta es/ EAC NA BTE Transmast to titanium e coupled transcutane transcutane y FDA conductiv
malleus/
ble device oid See to titanium ously ously NA NA e hearing
lateral
 Piezoelec
tric, to
TM incus
loss; CIC,
coupled
screw screw completel
coupled
Piezoelec CE mark, y in
tric, to FDA to CHL canal;
end of in skull in skull
stapes Phase II osseointegr to inability EAC,
CIC ated osseointegr to external
device FDA FDA implant ated
microph FDA CE clinical tolerate auditory
CE mark CE mark implant Medical) canal;
one mark trials
Acoustic FDA microph FDA,
Fig. 159.4 U.S. Food
, to TM Partial Partial CE mark CE mark one
Device Mild to Total Total No First molars and Drug
Sensor severe FDA CE mark Administr
Yes NA
Actuator CHL or Transmas Transmas
approved; Cortical Cortical Partial Partial conventi ation; HA,
NA
Approval NA No toid, toid
No skull bone skull bone onal HA, hearing
Implante surgery Soundbrid screw screw aid; MRI,
mandator Cortical Cortical
Hearing d required; Mild to ge magnetic
y skull bone skull bone SSD
Devices Placemen Yes, moderat Moderate microphon resonance
CHL, CHL, well well
t unless e CHL to severe e incus CE imaging;
inability to inability to
Indication SNHL NA or partial mark and
Yes Yes NA NA, not
s MRI visible; SNHL incus endaural and screws and screws applicable
No High- tolerate tolerate
Disadvant EAC removal
powered
largest
convention convention
; SNHL,
open fit install base No sensorine
ages output, al HA, al HA, CHL CHL,
No (Med-El) surgery ural
Occlusion SSD SSD
surgery See Fig. No fully unable to inability to required; hearing
occlusio required, 159.9 implantab tolerate No No No No loss; SSD,
n Yes low le; No percutaneo visible; single-
Simple Simple
visibility No Very ossicles placement, placement,
percutaneo us No EAC sided
; EAC high remain us No tolerate occlusio deafness;
No No
occlusio power; intact; nothing in nothing in
convention convention n TM,
n adjustabl al HA, al abutment
No ear or ear or tympanic
e abutment HA, SSD
requires mastoid mastoid membran
SSD
partial e.
incus for
removal ossicular
abnormal
ities

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159

2400 PART VII Otology, Neurotology, and Skull Base Surgery when evaluating whether technical improvements such as
increased

amplification gain are worth pursuing for a given patient.

Recruitment and Compression of Dynamic Range

One of the primary sources of frustration of patients with SNHL is reduced speech intelligibility. The common lament, “I can
hear, but I cannot understand,” underscores this point. This problem relates to abnormal frequency resolution and aberrant
patterns of growth in loudness, each of which reduces speech intelligibility in challenging listening conditions such as noisy
7,8
surroundings.

SNHL also imposes severe constraints on the dynamic range of perceived sound. For normal listeners, the dynamic range
from sensing soft sounds to the loudest tolerable noise is more than 100 dB. Within this wide dynamic range of hearing lies
an approximately 35 dB dynamic range of conversational speech. In contrast, the dynamic range of patients with SNHL is
often narrowed by both an increase in the threshold of audibility and a lowering of the ceiling of tolerance to high-intensity
sounds. This compaction of dynamic range leads to “recruitment,” an abnormal growth in loudness as sound intensity
9,10
increases. What sounds normal for someone with normal hearing may be too soft for someone with recruitment, whereas
what is too loud for someone with normal hearing is also too loud for the patient with recruitment. In effect, there is a much
narrower range of sound intensity that a patient with recruitment can tolerate. Furthermore, recruitment is observed in those
frequencies that are most impaired, which is most commonly higher frequencies which carry critical information for speech
understanding. Although many hearing aids can be programmed to prevent sound from amplifying into a range that is
uncomfortable, even the most advanced aids cannot fully replicate the complex, nonlinear response patterns of a healthy
10
cochlea.

Disordered Perception of Pitch and Sound Localization

Another challenge faced by conventional hearing aids relates to impaired pitch resolution and sound localization. Though
simple amplification strategies can compensate for this loss of sensitivity, they do little to restore the exquisite selectivity of
the cochlea in organizing pitch information. Much of the benefit provided by the normal auditory system is based on the
presence of two ears that independently sample the acoustic environment and send this information to the brain for
comparison and analysis. Sound detection is an important first step in hearing and can be performed reasonably well by one
sensitive ear. However, there is significant additional auditory benefit when sound input occurs through both ears. When only
one ear functions, or when there is a drastic difference in hearing levels between ears, the ability to locate the source of sound
decreases, as does suppression of background echoes and the ability to “block out” background noise.

All of these factors mentioned previously play a role to various degrees in patient dissatisfaction with traditional hearing aids
and combine to increase the noncompliance rate in hearing aid users. For most, these are the principle reasons why hearing
11
aids are unacceptable. With all these challenges facing conventional hearing aids, it is not surprising that many hearing aid
users feel frustrated with traditional aids.

THE PROMISE OF IMPLANTABLE HEARING DEVICES

The limitations of traditional air conduction hearing aids have been the driving force behind a new generation of implantable
hearing devices. Implantable hearing devices face most of the same challenges as traditional aids. They also have the added
risk of requiring surgery for their placement and are potentially more expensive. Yet their allure includes the possibility of
improved signal-to-noise ratios, greater amplification/gain potential, loss of

distortion and feedback, elimination of the occlusion effect, greater dynamic range, and improved cosmetics. For some who
simply cannot wear a hearing aid because of underlying anatomic problems or extreme discomfort, they may be the only
option.

It is widely accepted that implantable hearing devices should provide distinct advantages over conventional hearing aids,
including better cosmetics, improved fidelity, broader frequency response, less distortion, reduction or elimination of
feedback, and better speech understanding, without reducing residual hearing, limiting patient activities or predisposing
12,13
patients to infection. In other words, they should be at least as good as, and preferably better than, the best available
14
noninvasive method of hearing rehabilita- tion: binaural amplification with the best available aid.

Although significant strides have been made in many of these areas, implantable hearing devices have yet to deliver on all
these features. There also remain questions regarding the candidacy for implantation and willingness of patients to accept the
costs and surgical risks. As noted by Junker and colleagues, the number of patients in a fairly typical population of hearing
15
impaired individuals who would be considered realistic candidates is limited, on the order of 0.09%. The market for
implantable hearing devices may therefore not be sufficiently large to support the current array of device manufacturers. The
2002 financial failing of Symphonix Corp, the first company to clear U.S. Food and Drug Administration (FDA) hurdles and
market their implantable middle ear hearing device in the United States, strongly underscores this point, as do the subsequent
withdrawal of the Soundtec and TICA (totally implantable communication assistance device), as well as the financial issues
surrounding the Carina device described in the review of technologies that follows.

The focus of the remainder of this chapter will be to critically review the advantages and disadvantages of each of the
implantable hearing devices that are either in development or already in clinical use. Lastly, osseointegrated bone-conducting
hearing prostheses (OBHPs), which are w