Kasemsiri et al.

BMC Geriatrics (2021) 21:437

https://doi.org/10.1186/s12877-021-02325-4

RESEARCH Open Access

Effectiveness of a programable body-worn

digital hearing aid for older adults in a
developing country: a randomized
controlled trial with a cross-over design
Pornthep Kasemsiri1,2, Kwanchanok Yimtae1,2*, Panida Thanawirattananit1,2, Pasin Israsena3, Anukool Noymai3,
Supawan Laohasiriwong1,2, Patravoot Vatanasapt1,2, Pipop Siripaopradith4 and Pritaporn Kingkaew5

Abstract
Background: Hearing aids are important assistive devices for hearing rehabilitation. However, the cost of
commonly available commercial hearing aids is often higher than the average monthly income of individuals in
some developing countries. Therefore, there is a great need to locally produce cheaper, but still effective, hearing
aids. The Thai-produced P02 hearing aid was designed to meet this requirement.
Objective: To compare the effectiveness of the P02 hearing aid with two common commercially available digital
hearing aids (Clip-II™ and Concerto Basic®).
Methods: A prospective, randomized controlled trial with a cross-over design was conducted from October 2012
to September 2014 in a rural Thai community. There were 73 participants (mean age of 73.7 ± 7.3 years) included in
this study with moderate to severe hearing loss who were assessed for hearing aid performance, including probe
microphone real-ear measurement, functional gain, speech discrimination, and participant satisfaction with the
overall quality of perceived sound and the design of the device.
Results: There were no statistically significant differences in functional gain or speech discrimination among the
three hearing aids evaluated (p-value > 0.05). Real-ear measurements of the three hearing aids met the target curve
in 93% of the participants. The best real-ear measurement of the hearing aid following the target curve was
significantly lower than that of Clip-II™ and Concerto Basic® (p-value < 0.05) at high frequency. However, participants
rated the overall quality of sound higher for the P02 hearing aid than that of Clip-II™ but lower than that of
Concerto Basic® (p-value > 0.05). Participants revealed that the P02 hearing aid provided the highest satisfaction
ratings for design and user-friendliness with statistical significance (p-value < 0.05).

* Correspondence: kwayim@kku.ac.th
1
Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen
University, Khon Kaen 40002, Thailand
2
Khon Kaen Ear Hearing and Balance Research Group, Khon Kaen University,
Khon Kaen, Thailand
Full list of author information is available at the end of the article

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Kasemsiri et al. BMC Geriatrics (2021) 21:437 Page 2 of 8

Conclusion: The P02 hearing aid was an effective device for older Thai adults with hearing disabilities. Additionally,
its modern design, simplicity of use, and ease of maintenance were attractive to this group of individuals. These
benefits support the rehabilitation potential of this hearing aid model and its positive impact on the quality of life
of older adults in developing countries.
Trial registration: This study was registered under Clinicaltrial.gov NCT01902914. Date of registration: July 18, 2013.
Keywords: Hearing aid, Hearing loss, Older adults, Rural community

Background increase the accessibility of these devices to persons with

Hearing impairment is a global problem that affects hearing disabilities [13].
communication and individuals’ quality of life. In 2019, The National Electronics and Computer Technology
the World Health Organization (WHO) estimated that Center (NECTEC), a Thai governmental organization,
1.57 billion people globally presented with hearing loss. developed body-worn aid, digital, programmable hearing
Of all people with hearing impairment, 62.1% were older aids and has been producing them since 2006. The first
than 50 years. With an ageing society, the number of model, PDN-01B, also called P01, met the electro-
people with hearing loss will increase to an estimate of acoustical test standards set by the International Electro-
2.45 billion people by 2050 [1]. Furthermore, the preva- technical Commission (IEC 60118–7) [14]. Clinical testing
lence of hearing impairment is higher in low- and revealed that users were very satisfied at both 3, and 6
middle-income countries than in high-income countries months regarding ease of communication and speech
[2]. Presbycusis is the common cause of hearing loss understanding in a moderately reverberant room and
worldwide [3]. The exact prevalence of presbycusis is other environments with competing noise. Hence, the P01
difficult to determine due to the different criteria used model indicated suitable for users with moderate to severe
to define hearing loss; however, Wattamwar et al. [4] es- hearing impairment [14]. P01 was later modernized, giving
timated that presbycusis affects more than half of older it a similar look to a media player (model P02) (Fig. 1A–
adults by age 75 years and nearly all adults over age 90 E). This design with modified and more prominent but-
years. Hearing impairment negatively impacts personal tons and wheel volume control aimed to facilitate use by
health [5] and aspects of living, including communication, older adults, and its modern design encouraged older
socialization, and safety; therefore, hearing-impaired pa- adults to wear the hearing aid. The P02 battery was chan-
tients, especially older adults, may have increased social ged to a rechargeable lithium ion battery from the zinc-air
isolation and decreased autonomy [6]. Furthermore, hear- batteries in the P01 model.
ing loss may influence aspects of mental well-being, such This study was designed to compare the effectiveness
as anxiety, depression, and lethargy [7, 8]. Uhlmann et al. of a locally produced Thai body-worn hearing aid (P02)
also reported that hearing impairment is related to versus two common commercially available digital trimmer
dementia and cognitive dysfunction in older adults [9]. hearing aids, Concerto Basic® (Beltone Electronics Corp.,
Several studies have shown that age-related hearing loss is Denmark) and Clip-II™ (GN ReSound A/S., Denmark).
associated with an increased risk of developing dementia These three hearing aids have a similar level of amplifica-
[10, 11]. Therefore, aural rehabilitation is essential in the tion. Their specifications are provided in Table 1.
management of age-related hearing loss to prevent and
relieve the consequences that have negative effects on a Methods
person’s quality of life. A prospective, randomized controlled trial with a cross-over
Hearing aids play an important role in aural rehabilita- design was conducted from October 2012 to September
tion; however, the cost of hearing aids is higher than the 2014 in rural Thai districts, including Phuwieng; Wiengkao;
average monthly income of some individuals in Thailand and Nongnakum, Khon Kaen Province. Inclusion criteria
[12]. The WHO has estimated that the number of hear- were participants who were ≥ 60 years old, were new hearing
ing aids produced is less than one-tenth of that needed, aid candidates, had bilateral sensorineural hearing loss with
and three-quarters of these devices are distributed in an average pure-tone air-conduction threshold between 500
North America and European countries. One-quarter of and 2000 Hz in their better-hearing ear within a range of
these devices are distributed throughout the rest of the 41–75 dB, had no otorrhea for at least 3 months, had no
world, with half of these being distributed in high- pathology of the external ear canal by otoscopy examination,
income countries. Therefore, the WHO has also urged and had no suggestive middle ear effusion or mass by tym-
developing countries to produce their own hearing aids panometry. Participants were excluded if they had speech
or to import a large volume of low-cost hearing aids to discrimination with a Thai monosyllable word list of less
Kasemsiri et al. BMC Geriatrics (2021) 21:437 Page 3 of 8

Fig. 1 A–E The P02 is a digital programmable body-worn hearing aid. Its size dimensions are 65 mm × 45 mm × 15 mm, it has a built-in
rechargeable battery, and its total weight is 25.7 g. The P02 device consists of a channel for programming the adjustment system (1), a battery
capacity indicator (2), an ear receiver (3), an ear mould (4), an on/off switch (5), a channel charger (6), a battery compartment (red asterisk), a
programme button (7), an amplifier speaker (blue asterisk), a microphone (8), and a volume control (9). The P02 has a 2-channel wide dynamic
range compression with 5-band equalizer hearing aids. It has 4 memory slots with multi-memory tone indicators. Digital signal processing in the
P02 provided sound with a maximum amplification output of 123 dB and an average peak gain of 66 dB. Regarding the occlusion effect, we
adjusted the low-frequency gain and modified the ear mould with venting following an adjustment to the individual hearing threshold level

than 40% in both ears or suggestive retro-cochlear path- the experiment; hearing aid testing was performed on
ology. Written informed consent was obtained from all the better hearing ear. Hearing aid performance was
participants. evaluated by probe microphone real-ear measurement
Participants tested all three hearing aids with the P02 and was adjusted for each participant, and each hearing
device considered the intervention and Concerto Basic® aid met the best target curve by an audiologist in a quiet
and Clip-II™ devices considered as the controls. The room. The hearing aid was then placed in a bag for
testing order of the three hearing aids was produced by masking from the second audiologist and participants.
computer-generated randomization for each participant. In a standard soundproof room, participants’ functional
The audiologists were blinded to the generated order se- gain and speech discrimination before and after using
quence since each participant’s order was placed in an each hearing aid were evaluated by a second audiologist
envelope before the hearing aid testing began. All partic- to avoid bias. Participants and the second audiologist
ipants’ hearing levels were tested with a standard audio- were blinded to the brand of hearing aid and the hearing
gram before the hearing test day and on the same day as aid performance results.

Table 1 Comparison characteristics of the hearing aids

Characteristics P02 Concerto basic Clip-II™
Gain adjustable by pre-set options or user controls Programmable Screw trimmer Screw trimmer
Electroacoustic specification (IEC118–7 2 cc. Coupler) Digital Digital Digital
Maximum output (OSPL90) 118 ± 4 dBSPL 123 dB SPL 129 dB SPL 129 dB SPL
Maximum output at 1 KHz (OSPL90) 114 ± 4 dB 117 dB SPL 121 dB SPL 121 dB SPL
Maximum FOG (45–55 dB + 5 dB) 66 dB SPL 67 dB SPL 67 dB SPL
Maximum FOG at 1 KHz (42 + 5 dB) 63 dB SPL 64 dB SPL 64 dB SPL
Basic frequency range 200–4500 Hz 573–4400 Hz 100–3990 Hz 130–3690 Hz
Total dynamic distortion 500 Hz < 5% 0.6% 2.6% NA
Total dynamic distortion 800 Hz < 5% 3.8% 2.1% 2.1%
Total dynamic distortion 1600 Hz < 2% 0.4% 0.1% 0.1%
Equivalent input noise level < 25 dB SPL 31.4 dB SPL 24 dB SPL 24 dB SPL
Powered by zinc-air or rechargeable Rechargeable Lithium-ion Zinc-air models Zinc-air models
Battery current 11.8 mA 0.65 mA 0.65 mA
Maintenance Charged by electricity for Changing the battery Changing the battery
3 h every 3–4 days every month every month
Price Estimated 100 USD 300 USD 300 USD
Kasemsiri et al. BMC Geriatrics (2021) 21:437 Page 4 of 8

After each participant used the three hearing aids, the audiology testing to confirm that they met the eligibility
participant was asked to choose the top two ranks of criteria; 11 participants (6 that were suggestive of middle
hearing aids in order of preference according to their ear pathology, 4 with hearing levels that did not reach
overall satisfaction with the quality of perceived sound. study criteria, and 1 with a discrimination score worse
However, the participant was able to choose more than than 40%) were then excluded. Thus, 73 participants
one brand of hearing aid in the same ranking. eventually completed the full study protocol presented
The participant was still blinded to the hearing aid in the CONSORT diagram (Fig. 2).
identity during this choice task. In addition, participants All participants self-reported hearing loss, with 63%
were asked if they were satisfied with the hearing aid reporting tinnitus and aural pressure and 34% reporting
design by another researcher who was blinded to the vertiginous symptoms. The demographic data is shown
hearing aid data. The ranking of satisfaction in the hear- in Table 2. The mean unaided pure-tone average thresh-
ing aid design was evaluated in the same fashion as the old of the fitting ear was similar, although it was ana-
satisfaction of quality sound perception. lysed according to the different criterion guidelines,
The primary hearing aid performance outcome was including the American Speech-Language-Hearing Asso-
the functional gain in speech frequency, analysed by sub- ciation (ASHA), American Academy of Otolaryngology-
tracting the unaided and aided air-conduction threshold Head and Neck Surgery (AAO-HNS), and World Health
and pure-tone average threshold at 500–2000 Hz in the Organization (WHO) (Table 2). Functional gain and
free field. Real-ear measurement, speech discrimination speech discrimination were not significantly different
score, quality of sound, and design satisfaction were con- across the three hearing aids (Table 3). The mean air-
sidered secondary outcomes. Paired t-tests using 95% conduction pure-tone aided and unaided thresholds of
confidential intervals were used to compare the mean each frequency are displayed in Fig. 3.
differences. The chi-square test was used to test ordinal We found that the P02 mean air-conduction pure-
variables. A value of p < 0.05 was considered statistically tone aided and unaided thresholds were significantly
significant. This study was registered under Clinicaltrial.- better than those of the Clip-II™ and the Concerto Basic®
gov (NCT01902914), and the protocol was reviewed and at 1000 Hz (p-value < 0.05); conversely, the Clip-II™ and
approved by the Human Ethics Committee of Khon the Concerto Basic® performance at 4000 Hz was better
Kaen University (HE551268). than that of the P02 (p-value < 0.05).
In objective real-ear measurement testing, the three
Results hearing aids met the target curve in 93% of the partici-
One hundred eligible people initially consented to par- pants for each hearing aid. Subgroup analysis showed
ticipate in the study. However, 16 withdrew from the that the P02 real ear measurement was farther from the
study before visiting the audiology clinic on the day of target curve than that of the Clip-II™ and that of the
the proposed hearing aid evaluation. Thus, 84 partici- Concerto Basic® at a frequency of more than 2000 Hz;
pants underwent a repeat examination by otologists and the best closest objective real-ear measurement to the

Fig. 2 The research study protocol

Kasemsiri et al. BMC Geriatrics (2021) 21:437 Page 5 of 8

Table 2 Demographic data current practice, and the period of hearing aid
Characteristics Values 95% CI acclimatization became short. However, the follow-up to
Sex (n) adjust the hearing aid was continued after fitting until
Male 46 (63.01%) 51.55–73.18
the rehabilitation goal was reached.
The price of a hearing aid is one of the barriers against
Female 27 (36.99%) 26.82–48.45
patient use; therefore, locally produced hearing aids with
Mean age ± SD 73.67 ± 7.23 years 71.98–75.36 low cost would minimize this obstacle while maximizing
Range of age 60–92 years its coverage in low- and middle-income countries.
Air-conduction PTA (500–2000 Hz) Recently, several designs of hearing aids suitable for this
Rt ear 58.84 ± 14.84 dB 55.38–62.30 purpose have been made available. The body-worn hear-
Lt ear 57.64 ± 10.76 dB 55.13–60.15
ing aid is the largest one that may be more convenient
(for elderly individuals) as they are easier to see and ma-
Mean unaided PTA of fitting ear ± SD
nipulate [16]. Many older adults with hearing impair-
500–2000 Hz (ASHA) 58.92 ± 7.42 dB 57.19–60.65 ment may have comorbidities, including impaired vision,
500–3000 Hz (AAO-HNS) 59.63 ± 7.57 dB 57.86–61.39 limited touch sensation and range of movement, and de-
500–4000 Hz (WHO) 61.05 ± 7.67 dB 59.26–62.84 mentia [17–22]; therefore, a small area behind the ear or
on the ear hearing aid may lead to increased manage-
target curve of P02 was lower than those of the Clip-II™ ment issues for older adults [17]. Several studies show
and the Concerto Basic® (p-value < 0.05). However, par- that older adult hearing aid users have difficulties in
ticipants’ subjective assessment of overall sound quality basic hearing aid management, including correctly
showed a preference for the P02 device over the Clip-II™ inserting the aid or adjusting volume controls [23–25].
but was lower than that of the Concerto Basic® (p-value A body-worn design is less commonly used in developed
> 0.05). Participants’ satisfaction with the hearing aid de- countries. Taylor et al. reported that body-worn hearing
sign was the highest for the P02 (p-value < 0.05) (Fig. 4). aids comprised less than 1% of the hearing aid market
[26]. This small market share limits choices for selection
Discussion of the body-worn hearing aids with proper cost and suit-
Many factors affect hearing aid selection, including the ability for older users’ lifestyles in our country; therefore,
degree of hearing loss, problems experienced by the per- the P02 model, a Thai manufactured digitally
son, patient motives and expectations, personality traits, programmable body-worn hearing aid, was designed to
auditory counselling, and economic issues [15]. Further- suit older adult users’ lifestyles more appropriately. This
more, the period of hearing aid acclimatization is the hearing aid provides older users with several benefits,
other factor that may affect one’s choice in hearing aid. such as greater electroacoustic flexibility, easier volume
Unfortunately, in Thailand, the current practice is that control management, multiple programmes, and faster
hearing aid trials are done on the same day with hearing fitting.
aid fitting. This is not ideal but is conducted according In our study, functional gain and speech discrimin-
to government policies of hearing aid testing, limiting ation with the P02 device were found to be similar to
the number of tested hearing aids and travel expenses those obtained with Clip-II™ and Concerto Basic®. How-
that burden the patient if they were to return for each ever, Concerto Basic® and Clip-II™ provided a signifi-
test. Therefore, our study was designed according to cantly better functional gain than the P02 device at

Table 3 Comparison of functional gain and speech discrimination among the three hearing aids
Hearing aids P02 Clip-II™ Concerto basic®
Average functional gain (dB) 20.14 ± 6.23 19.41 ± 5.40 19.44 ± 5.43
(95% CI: 18.66–21.54) (95% CI: 18.15–20.65) (95% CI: 18.15–20.65)
Average speech discrimination (%) 67.8 ± 17.13 67.6 ± 18.13 68.8 ± 17.91
(95% CI: 63.80–71.79) (95% CI: 63.37–71.83) (95% CI: 64.62–72.98)
Comparison of hearing aids P02 VS Clip-II™ P02 VS Concerto Basic® Clip-II™ VS Concerto Basic®
Mean difference of functional gain 0.73 ± 4.08 0.70 ± 4.20 0.03 ± 2.84
(95% CI: − 0.22 - 1.68) (95% CI: − 0.28 - 1.68) (95% CI: − 0.63 - 0.69)
P-value 0.13 0.16 0.93
Mean difference of speech discrimination 0.22 ± 6.7 1.00 ± 6.45 1.22 ± 6.43
(95% CI: − 1.55 - 1.99) (95% CI: − 0.51 - 2.50) (95% CI: − 0.28 - 2.72)
P-value 0.78 0.19 0.11
Kasemsiri et al. BMC Geriatrics (2021) 21:437 Page 6 of 8

Fig. 3 The mean air-conduction pure-tone aided and unaided thresholds for each frequency across the Clip-II™, the Concerto Basic®, and P02
hearing aids

4000 Hz, whereas the functional gain of the P02 device from the target curve, with the P02 curve being furthest
was significantly better than that of Concerto Basic® and apart at the highest frequency. Noffsinger et al. [27] have
Clip-II™ at 1000 Hz. Although these differences reached previously shown that the wide dynamic range compres-
statistical significance, differences less than 10 dB may sor produces a clearer and more comfortable sound,
have a minor impact on hearing in clinical practice. Re- likely reflected in the participants’ higher satisfaction
garding objective real-ear test performance, Concerto with the P02 device regarding overall sound quality over
Basic® and Clip-II™ were better than the P02 model at either the Clip-II™ or Concerto Basic®.
high frequencies. Notably, participants’ subjective satis- The P02 design, similar to a modern music media
faction ratings of overall sound quality were higher for player rather than appearing as a disability aid, reduces
the P02 device than for both alternatives. These results stigma for the wearer. Undoubtedly, this positive attitu-
may be due to the different techniques utilized to limit dinal feature contributed to its higher satisfaction rating
excessive amplifier sound across hearing aids. Clip-II™ compared with the other two aids. The P02 is a lighter-
and Concerto Basic® use linear peak clipping, whereas weight hearing aid with a built-in rechargeable battery,
the P02 model uses a wide dynamic range compressor. holds a 3-day charge, and is easily charged by a main
Both limiters produce some sound distortion and loss of electricity supply. Using rechargeable batteries is more
sound detail; thus, the result of the real-ear test showed convenient than having to regularly replace disposable
that the curves of the three hearing aids were different batteries and reduces electronic waste. The P02 hearing

Fig. 4 Comparison of hearing aid performance

Kasemsiri et al. BMC Geriatrics (2021) 21:437 Page 7 of 8

aid is still in the prototype phase, but the cost is esti- S.L., P.V., P.S., and P.K2. participated in critically revising the article. All authors
mated to be 100 USD, which is cheaper than currently have read and approved the manuscript.

available commercial aids; thus, it is more affordable for

Funding
older adults in a rural community in developing This study was granted by Health Systems Research Institute, Thailand (Grant
countries. number 55–052). The funder had no role in study design, data collection
In summary, the P02 device seemed as effective as and analysis, decision to publish or preparation of the manuscript.

Clip-II™ and Concerto Basic®, the commonly available

Availability of data and materials
commercial hearing aids, although participants gave the The protocol, datasets used and/or analysed during the current study are
P02 model higher subjective ratings for quality of sound. available from the corresponding author on reasonable request.
A P02 limitation is the detail distortion that individuals
experienced in high frequencies, as shown in the real-ear Declarations
result. Any adjustments to obtain more gain in the high- Ethics approval and consent to participate
frequency range should maintain the same comfortable This study was approved by Khon Kaen University Ethics Committee for
Human Research (HE551268). All participants provided written informed
sound. A limitation of this study is the short time that consent before enrolment. All methods were performed in accordance with
individuals spent using hearing aids to acclimatize to the relevant guidelines and regulations (Declaration of Helsinki).
them; therefore, a longer duration of use of the hearing
aids would be useful to assess satisfaction with the Consent for publication
Not applicable.
device.
Competing interests
Conclusion The authors declare that they have no competing interests.
The P02 model, a Thai-produced digital programmable Author details
body-worn hearing aid, seemed as effective as two other 1
Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen
comparable common commercial hearing aids for use University, Khon Kaen 40002, Thailand. 2Khon Kaen Ear Hearing and Balance
Research Group, Khon Kaen University, Khon Kaen, Thailand. 3National
with older Thai adults with hearing disabilities. Further- Electronics and Computer Technology Center (NECTEC), National Science
more, the P02 device has the benefits of a modern and Technology Development Agency (NSTDA), Prathumthani, Thailand.
4
design, simplicity of use, potential cost savings, and Phuwieng Hospital, Ministry of Public Health, Khon Kaen, Thailand. 5Health
Intervention and Technology Assessment Program (HITAP), Ministry of Public
maintenance convenience via the use of a built-in re- Health, Nonthaburi, Thailand.
chargeable battery.
Received: 6 February 2021 Accepted: 6 June 2021
Abbreviations
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