External Environmental Assessment: Market and Customers

Read and analyze the assigned article.  The review is in two parts.  First, using proper APA (7th ed.) format, write a 1-page summary noting all main elements or ideas of the article.  The second part is your reaction to this article.  Your reaction should include implications or application of the ideas from the article in your own current or future project leadership roles.  Give specific examples of your use or potential use of what you learned from the ideas in this article. Two page minimum, four page maximum. The individual article review reports will be graded on the content and quality of writing.  Make your report clear and concise, grammatically correct and professional.  You must include all the points listed above and adhere to the length requirement.

Strategic Planning marketing

Emerging Technologies, Market Segments,
and MarkeTrak 10 Insights in Hearing
Health Technology

Brent Edwards, Ph.D.1

ABSTRACT

Hearing health care is rapidly changing through innovation in
technology, services, business models, and product categories. The
introduction of hearables and over-the-counter (OTC) hearing aids
in particular will change the market for hearing help and the role of the
hearing care professionals (HCPs). This article focuses on how these
products will be differentiated from HCP-fit hearing aids through their
ability to address the unmet needs of different consumer segments
within the population of people with hearing dysfunction. The unmet
hearing needs of each segment are discussed, and the size of each
segment estimated, demonstrating a large potential market for hearables
and a smaller potential market for hearing aids than has been previously
mentioned in the literature. The results from MarkeTrak 10’s survey of
consumers’ attitudes toward an OTC model are reviewed, showing that
approximately half of both hearing aid owners and nonowners are
uncomfortable doing hearing- and hearing aid–related tasks on their
own without the assistance of an HCP and would be unlikely to
purchase OTC hearing aids if available today. MarkeTrak data are also
shown that demonstrate that the majority of hearing aid and personal
sound amplification product owners believe that the HCP helped or
would have helped with their hearing devices. Finally, challenges to
OTC hearing aids becoming successful are discussed.

KEYWORDS: hearing aids, over the counter, hearables, hearing

loss

1National Acoustic Laboratories, Sydney Australia.
Address for correspondence: Brent Edwards, Ph.D.,

National Acoustic Laboratories, Level 4, 16 University
Avenue, Macquarie University, NSW 2109, Australia
(e-mail: brent.edwards@nal.gov.au).

MarkeTrak 10: Patients; Providers; Products; and Pos-
sibilities; Guest Editor, Thomas A. Powers, Ph.D.

Semin Hear 2020;41:37–54. Copyright # 2020 by Thieme
Medical Publishers, Inc., 333 Seventh Avenue, New York,
NY 10001, USA. Tel: +1(212) 760-0888.
DOI: https://doi.org/10.1055/s-0040-1701244.
ISSN 0734-0451.

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mailto:

https://doi.org/10.1055/s-0040-1701244

INNOVATION IN HEARING AIDS
Innovation is anything that creates value in
new ways. This is typically embodied in the
creation of a new product, service, process, or
business model that addresses unmet needs of
a person or organization.1 By this definition,
innovation has had a significant impact on
hearing health care over the past two decades
and is continuing to change the hearing health
care landscape.

This changing hearing health care land-
scape has been followed over the past 30 years
through the MarkeTrak series of surveys. The
MarkeTrak research has documented much of
the changes in terms of the market penetration,
consumer views on technology, satisfaction
with professional services, and the core tech-
nology of hearing instruments. The latest
survey, MarkeTrak 10, has provided additional
insights in these topics and will be explored as
we examine the innovation and trends in the
hearing health care space.

Much of the hearing health innovation over
the past two decades has been in the form of
technology. Two technology platforms in par-
ticular transformed the hearingaidtechnological
landscape by enabling a series of innovations that
met the unmet needs of those with hearing loss
and hearing care providers (HCPs). The intro-
duction of digital signal processing (DSP) in a
hearing aid in 1996 and of programmable DSP
in 1999 allowed for the rapid development and
implementation of sophisticated signal proces-
sing features such as feedback cancellation, noise
reduction, frequency lowering, data logging, and
others. These innovations improved the audibil-
ity, sound quality, speech understanding, and
usability of hearing aids when fit and adjusted
properly, with secondary benefits such as re-
duced cognitive load,2,3 mental fatigue,4 and
reduced social isolation.5 In 2004, the introduc-
tion of wireless technology led to the develop-
ment of innovative features such as streaming
sound between hearing aids and consumer elec-
tronics products, connectivity between hearing
aids and smartphones that enabled apps to give
greater hearing aid control to the user, and
data sharing between left- and right-worn hear-
ing aids that enabled beamforming and other
sophisticated signal processing benefits for hear-
ing aid wearers.6,7

In recent years, innovation has expanded
beyond technology into services, business
models, and product categories for new market
segments.

Teleaudiology, or more broadly “connected
hearing health,” is allowing HCPs to provide
hearing health services to their clients remotely.
Innovation in this area has allowed for the
provision of traditional audiological services
to a patient in a remote location, improving
accessibility to hearing health services.8 Con-
nected hearing health is also improving the
connection between patient and HCP by allo-
wing the HCP to provide follow-up services
like counseling and hearing aid fine-tuning
remotely, eliminating the need for an office
visit while also giving the opportunity for faster
and more frequent service delivery.9

Innovation in hearing aid distribution
models is disrupting the traditional way one
gets a hearing aid, which historically has been
to visit an HCP’s office to have one’s hearing loss
measured and be fit with a hearing aid. While
mail order hearing aids and online hearing tests
have existed for well over a decade,10 some of
those were distributed in violation of Food and
Drug Administration (FDA) and state regula-
tions. A new generation of hearing aids is now
being distributed that meet FDA and state
regulations, involving audiologists in the deliv-
ery process via online or telephone communica-
tion, following Good Manufacturing Practices,
producing proper labeling on the products, and
following other medical device regulations for
hearing aids. Hybrid approaches to hearing aid
distributionalsoareemerging,whereaudiologist
services are provided online or by phone and the
hearingaidismailedtothe userwithinstructions
for self-fitting, while still allowing for the possi-
bility of an in-person visit to an HCP’s office and
face-to-face professional assistance.11 People
can even test their hearing on their own with
an FDA-approved hearing screening system,12

and smartphone apps can do a reasonable job at
measuring pure-tone thresholds in a quiet
environment.13

Innovation in new product categories is
helping to develop new market segments. Hea-
rables, or ear-level worn earpieces with wireless
connectivity,14 have been developed that are
multifunctional, providing wireless audio

38 SEMINARS IN HEARING/VOLUME 41, NUMBER 1 2020

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connections to devices like smartphones and
remote microphones, sensors that measure bio-
logical function, microphones that enhance and
augment environmental sounds, and more. Hea-
rables are not medical devices regulated by the
FDA because they are not intended for use in the
treatment of hearing loss, and as such their
distributors and manufacturers do not have to
follow the requirements that those for hearing
aids do. As technology typically associated with
hearing aids, such as directional microphones or
noise reduction, starts to appear in hearable
devices, whether a device is a hearing aid or a
hearable will become more difficult to determine.
Ultimately, the same physical device could be
either a hearing aid or a hearable and which one it
is will depend only on its intended use, that is,
whether it is intended to treat hearing loss or not.

We are likely to see a continuation of
service and business model innovations that
develop new hearing market segments with
the coming creation of an over-the-counter
(OTC) hearing aid category by the FDA. These
OTC hearing aids may expand the reach of
hearing health care by meeting the unmet needs
of a segment of people with hearing loss who,
until now, have rejected traditional hearing aids
as a solution.

OVER-THE-COUNTER HEARING AID
LEGISLATION
Two reports were influential in promoting the
creation of an OTC category of hearing aids—
the President’s Counsel of Advisors on Science
and Technology (PCAST) report15 and the
National Academy of Sciences, Engineering
and Medicine (NAS) report.16 Both of these
reports noted that affordability and accessibility
were significant barriers to some people getting
hearing aids. As a response, the Over-the-
Counter Hearing Aid Act of 2017 mandated
that the FDA create an OTC category for
hearing aids that is intended for adults with
mild-moderate losses whereby the OTC
hearing aids could be acquired without the
involvement of a licensed professional, as man-
dated by many state regulations.17 These OTC
hearing aids could be sold in stores, by mail,
online, or any other direct-to-consumer distri-
bution channel.

Hearing aids have been sold for many years
through the Internet and other channels without
the involvement of licensed professionals in
contrast to claims of poor accessibility and
affordability of hearing aids. (At the time of
this writing, a search on Amazon and Google for
“cheap hearing aid” produces a list of many
hearingaidsthatcanbeboughtonlineforaround
$100 or less.) Regardless, the OTC hearing aid
law will allow organizations to legally sell hear-
ing aids directly to consumers that it might not
have otherwise, as long as those organizations
abide by the regulations set by the FDA. The
benefit to the consumer will be knowing that
those hearing aids have met FDA medical device
requirements such as being manufactured under
a proper quality management system, will have
appropriate labeling on the products, and meet
other requirements without being in violation of
state regulations requiring the involvement of
certified professionals.

The OTC Hearing Aid Act of 2017 requi-
res the FDA to create an OTC hearing aid
category and issue regulations on them by
August 2020.

MARKET SEGMENTATION
With these emerging new categories of hearing
devices that could potentially have similar, if
not identical, features, the question arises of
how to differentiate between hearables, HCP-
fit hearing aids, and OTC hearing aids. One
way to determine the differences between these
products is to consider for which population
groups these solutions provide value.

Innovations find success by providing solu-
tions for the unmet needs of a group of custo-
mers. So, if hearables and OTC hearing aids are
tobe successful,whatunmet needs willthey meet
andwhoseneedswillthosebe?Consider thetotal
population of people with some sort of auditory
dysfunction, whether due to audiometric hearing
loss, central auditory nervous system issues, or
other deficits.18 A reasonable premise is that this
population has unique hearing needs that could
be helped by those innovative solutions.

This population of people with auditory
dysfunction can be segmented into distinct
groups of people with different characteristics
and potentially different hearing needs. Fig. 1

EMERGING TECHNOLOGIES, MARKET SEGMENTS, AND MARKETRAK 10 INSIGHTS/EDWARDS 39

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shows one possible segmentation for this pop-
ulation. Each segment is characterized by
whether someone self-identifies as having hear-
ing difficulty (HD) or not (NHD), and whether
someone has an audiometric hearing loss (HL)
or not (NHL). Of the HD-HL group—those
who self-identify as having hearing difficulty
and who also have an audiometric hearing
loss—a further segmentation can be made on
whether they have accepted HCP-fit hearing
aids as a solution for their needs or not. Thus,
the population of people with hearing dysfunc-
tion can be segmented into five distinct groups,
each with the possibility for unique hearing
needs that may be met by different hearing
solutions.

No Hearing Difficulty Group
Segments A and B in Fig. 1, the NHD-NHL
and NHD-HL groups, respectively, represent
those with some form of auditory dysfunction
but who do not self-identify as having hearing
difficulty. In other words, for whatever reason
they do not have a normal auditory system, but
they do not perceive themselves as having a
hearing problem.

Segment A, the NHD-NHL group, will
not be considered candidates for any hearing
solutions primarily because they do not perceive
themselves as having any hearing difficulty and
therefore do not perceive themselves as having
any unmet hearing needs, nor would an audio-
gram identify them as having a hearing loss; so,
no HCP would recommend any solutions if the
person happened to have their hearing tested.

Segment B, the NHD-HL group, is par-
ticularly interesting because they do have a
measurable hearing loss yet do not self-identity
as having hearing difficulty. Reasons for their
lack of self-perceived hearing difficulty could be
because they have a lifestyle that does not
require listening in difficult situations and
therefore they have not experienced any hearing
difficulty, they are successfully compensating
for loss of audibility through extra cognitive
effort, or they lack general self-awareness of
their situation or condition.19–21 (This group
does not include those who are personally aware
but will not admit they have hearing difficulty
to others.) Regardless of why, they do not
believe that they have hearing difficulty and
are likely unaware that they have an audiometric
hearing loss. This group might benefit from

Figure 1 The total population with hearing dysfunction segmented according to whether they self-report as
having hearing difficulty or not (HD or NHD, respectively) and whether they have an audiometric hearing loss
or not (HL or NHL, respectively). Those with both self-reported hearing difficulty and an audiometric hearing
loss (HD–HL) are further segmented into hearing aid owners and hearing aid nonowners.

40 SEMINARS IN HEARING/VOLUME 41, NUMBER 1 2020

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wearing a hearing aid that improves audibility,
but they are unlikely to ever realize that benefit
because they do not believe that they have a
need for improved hearing and will not seek out
hearing solutions. If they happened to have
their hearing tested such as at a screening event,
they will be unlikely to follow through with a
visit to an HCP given their lack of a perceived
need. Therefore, issues such as accessibility,
affordability, or stigma are not reasons that
this population does not wear hearing aids.
They simply would not present to an HCP or
seek hearing help of any kind because they do
not have a need for hearing help.

When considering the viable market for
hearing aids or hearing help, neither the
NHD-NHL group nor the NHD-HL group
should be included. More specifically, estimates
of how many people who need hearing aids but
do not have them should not include the NHD-
HL population even though they have a measur-
able hearing loss.22 The populations in Segments
A and B, however, are potential customers for
consumer audio products such as headphones,
earphones, or other audio devices that address
other hearing needs such as access to music,
podcasts, augmented audio, and other offerings
that are marketed to people with normal hearing.

Hearing Difficulty, No Hearing Loss
Group
Segment C in Fig. 1 is the HD-NHL group.
These are people who self-identify as having
hearing difficulty but have audiometrically nor-
mal hearing. Manypeoplewithin this population
present at audiology clinics but are offered no
help because they are not diagnosed with a
hearing loss. Hearing aids, whose primary func-
tion is to improve audibility through the provi-
sion of gain, are presumed not to be a solution for
this population since audibility as measured by
the audiogram is not compromised. People in
this segment may have a variety of reasons why
they have difficulty hearing, including auditory
processing disorder, cognitive dysfunction,
attention-deficitdisorder,andsynaptopathy.23,24

This population could benefit from technology
that helps with their self-reported hearing diffi-
culty but are presumably seeking something
other than amplification since audibility is not

an issue. Their needs are primarily with speech
understanding and they may benefit from devices
that improve the speech-to-noise ratio or provide
some other mechanism for improving the
understanding of their speech target, whether
it is the speech of someone in person, on a
television, or on a phone. Thus, persons in the
HD-NHL segment are potential candidates for
hearables, which are not intended to compensate
for hearing loss but to improve hearing ability in
some way other than the provision of amplifica-
tion. Whether any specific person in this group is
a candidate for any specific hearable device will
depend on whether that device has capabilities to
meet the individual needs of the person.

The HD-NHL population should not be
considered part of the viable market for hearing
aids, whether OTC or HCP delivered, because
they are considered to have normal audibility
that is assumed to be a prerequisite for needing
the amplification of a hearing aid.

Hearing Difficulty, Hearing Loss Group
Segments D and E make up the HD-HL
group—those who self-identity as having hear-
ing difficulty and also have audiometric hearing
loss. This group is the target market for hearing
aids because they have audibility issues that
could benefit from gain and they have a self-
recognized need.

The HD-HL group in Segment D consists
of traditional hearing aid wearers, meaning that
they had their hearing tested by an HCP and
were fit with hearing aids. While they may have
delayed obtaining hearing aids once they real-
ized that they had a need, they did not reject the
traditional approach to obtaining hearing help
from an HCP and a hearing aid.

TheHD-HLgroupinSegmentE,however,
have not pursued hearing aids through an HCP
even though they have an audiometric loss and
self-identify as having a need to hear better.
There are many reasons that someone would
have treatable hearing loss and know that they
have hearing difficulty yet still not pursue a
solution. The PCAST and NAS reports suggest
that accessibility and affordability are two of the
main reasons. Additional reasons include stigma
effects, lack of awareness of how to take action,
lack of belief that hearing aids can be beneficial,

EMERGING TECHNOLOGIES, MARKET SEGMENTS, AND MARKETRAK 10 INSIGHTS/EDWARDS 41

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and lack of support from significant others.25–28

Their needs are not unmet for lack of a technol-
ogy solution but for lack of a solution that helps
them make a decision to get a hearing aid by
meeting such unique needs as affordability,
accessibility, confidence in treatment success, or
eliminating stigma. For those in this segment
who have not obtained a hearing aid from an
HCP because of affordability and accessibility,
OTC hearing aids are attractive as a hearing
health solution. OTC hearing aids will not de
facto address any of the other reasons that cause
people in this group to not get a hearing aid
through an HCP, although positive brand rec-
ognition and effective direct-to-consumer mar-
keting could address such issues as lack of a belief
of benefit from hearing aids or lack of support
from significant others.

Thus, each segment has different hearing
help needs that could be addressed by different
hearing device solutions. Knowing this would
help estimate the size of the market for each
solution: hearables, HCP-fit hearing aids, and
OTC hearing aids.

POPULATION SEGMENT
ESTIMATES
While there has been no attempt to estimate the
population size within each segment within
Fig. 1 with a consistent criterion for each, there
have been independent attempts to estimate the
population size of individual segments or the
sumofasubsetofthe segments.Forexample,the
prevalence of hearing loss in adults has been
estimated from both self-reported data and from
audiometric hearing loss data, that is, either
estimates of the sum of Segments C, D, and E
or the sum of segments B, D, and E, respectively.
Combining these estimates with estimates of
individual segments, one can use simple arith-
metic to estimate the population size of seg-
ments for which there are no data. While the
criteria with which people are associated with
each segment for the purpose of estimating
population size are not consistent (e.g., criteria
for no hearing loss, criteria for self-identifying as
having hearing difficulty, or age criteria consid-
ered for the estimates), we can still attempt to
estimate the size of each segment from various
sources.

Several estimates exist for the size of the
total adult population who self-report as having
hearing difficulty (i.e., the sum of Segments C,
D, and E or the sum of the HD-NHL and the
HD-HL populations). MarkeTrak 10 has found
that 10.8% of all respondents (n ¼ 55,650), with
13.1% of adults, self-report as having hearing
difficulty,whichis32.6millionpeoplebasedona
total U.S. adult population of 249.2 million in
2018.29 Blackwell et al30 estimated the percent-
age of adults who had hearing difficulty to be
15%, which is 37.4 million. A challenge with
each of the different population estimates is the
criteria used. They rely on self-reported data but
used different questions on which to make the
determination that someone perceives them-
selves to have hearing difficulty.

Similarly, several estimates have been made
on the population size of adults with audiometric
hearing loss (the sum of Segments B, D, and E).
Goman and Lin31 recentlyestimated the number
of people in the United States aged 20 and over
with audiometric hearing loss to be 38.1 million.
We can safely assume that the number of people
aged 18 and older also to be 38.1 million as well
since the number of people aged 12 to 19 with
hearing loss is only 0.06 million.31 With a total
adult population size of 249.2 million and a total
adult HL population size of 38.1 million, the
totalNHLpopulationsizemustbethedifference
or 211.1 million.

Several estimates exist for the size of the
population of people with normal audiometric
hearingbutself-reportedhearingdifficulty(Seg-
ment C), varying from 20% of the NHL popu-
lation32 or 42.2 million people, to 29% of the
NHL population33 or 61.2 million people, to a
range of 20 to 40% of the NHL population34 or
42.2 to 84.4 million people. Tremblay et al,35

using a much stricter criteria for normal audio-
metric hearing of pure-tone thresholds less than
20 dB HL at 0.5, 1, 2, 3, 4, 6, and 8 kHz, found
that 12% of a cross-section population of the
Beaver Dam Offspring Study had self-reported
hearing difficulty, which would be 25.3 million
out of the 211.1 million NHL adults referenced
earlier. These different HD-NHL population
size estimates vary in large part due to the
differences in criteria used to classify someone
ashaving noaudiometrichearing lossandhaving
self-reported hearing difficulty. Note also that

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these estimates for the size of Segment C exceed
the aforementioned estimates for the size of the
sum of Segments C, D, and E, which is mathe-
matically inconsistent. Again, the challenge in
comparing these population estimates is the lack
of consistency in criteria. In order for the esti-
mate of the HD-NHL (Segment C) population
size to be reasonably smaller than the estimate of
the total HD (the sum of segments C, D, and E)
population size, we will use the smaller popula-
tion estimate of 25.3 million from Tremblay et al
for the HD-NHL group and the larger popula-
tion estimate of 37.4 million from Blackwell et al
for the HD group.

There have been many attempts to estimate
the population size of HD-HL adults who wear
hearing aids, Segment D. Chien and Lin36

estimated the number of people over 50 who
have hearing aids to be 3.8 million based on
NHANES data, which isanincompleteestimate
of the total adult population who wears hearing
aids in the United States since it does not include
people younger than 50 years. Popelka et al37

estimated the percentage of people with hearing
loss in their worst ear who have hearing aids to be
14.6%. Applying this percentage to the Goman
and Lin’s estimate of 60.1 million people with
audiometric loss in at least one ear31 gives an
estimate of 8.8 million people with hearing aids,
although Popelka et al’s estimate is for the total
population, not just adults. MarkeTrak 10 esti-
mates that 3.7% of the total population have a
hearing aid, resulting in an estimate of 12 million
people. Again, this number is for the total
population, not just adults. MarkeTrak 9 esti-
mated that less than 1% of the population
younger than 18 years had a hearing aid which
is 0.7 million people, which would put the total
adults with hearing aids at over 11.3 million
people.

Wecancross-check these hearing aid owner
numbers with the number of hearing aids sold in
a year. Given that an average duration someone
keeps a hearing aid before replacing it with a new
one is approximately 5 years, one could estimate
the population size of hearing aid wearers by
summing the number of hearing aids sold over
the past 5 years. This totals 17.9 million devi-
ces.38–42 Over 90%ofpeoplefitwithhearing aids
are fit with two devices,43 which means that
17.9 million hearing aids were fit on at least 9.4

million people over the past 5 years. If we
subtract the estimate of 0.7 million people under
18 who have hearing aids from this number, the
estimatefor adults withhearingaidsbecomes8.7
million, which is remarkably close to the 8.8
million derived from the data of Popelka et al
and Gorman and Lin. This number, of course, is
not exact because there were some people who
bought their hearingaidswithinthattime period
who replaced them with new devices before the
end of 2018, which would decrease the popula-
tion estimate. Additionally, there are people still
wearing their hearing aids who acquired them
more than 5 years ago, which would increase the
population estimate. There are also people who
purchased hearing aids in that time period who
have died. Despite these additional uncertain-
ties,wewillusetheestimateof8.7millionpeople
for the HD-HL group with hearing aids.

Fig. 2 shows the adult population segments
assuming 8.7 million hearing aid wearers, 25.3
million in the HD-NHL population, 38.1
million in the total HL group, and 37.4 million
in the total HD group. Population estimates of
Segments E and B can be calculated to keep
mathematical consistency with these defined
constraints. This results in an estimate of
population size in Segment E, or the HD-
NHL population who do not have hearing
aids, to be 3.4 (37.4–25.3–8.7) million people,
after which the NHD-HL group can be esti-
mated to be 26 (38.1–8.7–3.4) million people.
See Fig. 3 for the final population estimates.
These two calculations are dependent on the
assumptions of the population sizes for the
other population segments and can therefore
change dramatically if one or more of the other
segment size estimates change.

Oneofthemostproblematicassumptionsin
the creation of the segment population in Fig. 3
was the size of the total HD population (the sum
of Segments C, D, and E) because many of the
populationestimatesforSegmentCaloneexcee-
ded the population estimates for the sum of
Segments C, D, and E, which cannot be valid.
One could argue that a larger number should
have been used for the sum of Segments C, D,
and E than 38.2 million. If an estimate of, say, 50
million were used, then the estimate for the
population of Segment E would be 16 million
instead of 3.4 million. The 3.4 million number

EMERGING TECHNOLOGIES, MARKET SEGMENTS, AND MARKETRAK 10 INSIGHTS/EDWARDS 43

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Figure 2 Estimated U.S. adult population numbers for those with self-reported hearing difficulty and no
audiometric hearing loss (C), those who are hearing aid owners (D), the total population with audiometric
hearing loss in both ears (B þ D þ E), and the total population with self-reported hearing difficulty (C þ D þ E).
Numbers represent millions.

Figure 3 The estimated U.S. adult population numbers for different segments of those with auditory
dysfunction. Segments B and E were calculated from the numbers given in Figure 2. Numbers represent
millions.

44 SEMINARS IN HEARING/VOLUME 41, NUMBER 1 2020

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seems low considering that Kochkin44 estimated
that there were 8.8 million people without
hearing aids who had a similar hearing loss
composite score as those with hearing aids.
Thisisimportantbecausethetotalviablehearing
aid market is assumed to be the sum of Segments
D and E, and the potential OTC market can be
estimated to be at least the size of Segment E.

So, after all of this, what can be said about
the potential market size for hearables and
OTC hearing aids? The population for whom
hearables may address an unmet need is the
HD-NHL group, which has been estimated
to be at least 25.3 million adults in the United
States. This is a significant untapped mar-
ket—much larger than the population of
current hearing aid wearers. Organizations
looking to provide solutions with hearables
do not need to focus on current hearing aid
wearers as their target market, since they
appear to be happy with their hearing aids
and HCP as will be discussed later, but focus
on addressing the unique unmet needs of the
HD-NHL group.

The potential market for OTC hearing
aids is at least the population in Segment E,
the HD-HL group without hearing aids.
Possible customers also could include people
in Segment D, the HD-HL group with
hearing aids. Whether people in Segment D
have a need for such a device remains to be
seen and will be investigated in the next
section. What is clear is that the people in
Segment B, the NHD-HL group, are unlikely
to be candidates for OTC devices primarily
because they do not self-perceive as having a
hearing problem and therefore OTC hearing
aids will not address any need for people in
this population. Using the numbers in Fig. 3,
72% of those who could benefit from a hearing
aid have one, much larger than the 14 to 33%
estimated in the NAS report or the 15 to 30%
estimated in the PCAST report. Additionally,
68% of those with audiometric hearing loss
have no self-perceived hearing difficulty, sim-
ilar to the 66% number found for the percent-
age of Canadians aged 40 to 79 with
moderate-to-profound high-frequency audio-
metric hearing loss who do not self-report as
having hearing loss,45 albeit using a different
criteria for audiometric hearing loss.

MARKETRAK OVER-THE-COUNTER
RESULTS
With the creation of an OTC category of
hearing aid looming, MarkeTrak 10 asked
several questions related to the potential success
of these devices to meet the unmet needs of the
HD population.

The questions about OTC hearing aids
were preceded with the following information:

� “In the near future, consumers with mild/
moderate hearing loss will have the option to
purchase hearing aids ‘OTC’ (on their own,
from a store, Web site, etc.) without the
current requirement to be assessed by a
hearing care professional first (which is
required in all states). Note: Currently,
personal sound amplifiers (that look like
hearing aids) can be purchased directly
without this requirement.”

� “When purchasing “OTC,” the cost of the
hearing aid would be lower because there
would be no hearing evaluation, counseling,
fitting, or follow-up provided by a profes-
sional before, during, or after the sale.”

MarkeTrak 10 queried 963 individuals
who self-identified as having a hearing difficul-
ty and who currently own a hearing aid. When
asked if they would have purchased an OTC
hearing aid instead of going to a professional if
the option had been available to them, few said
that they would have, with 88% responding that
they either probably or definitely still would
have purchased a hearing aid through an HCP
(see Fig. 4). Fig. 5 shows the breakdown of
responses by age and gender, with little differ-
ence across groups, although there was a slight
tendency for the youngest age group to respond
in the “not sure” category compared with the
older groups. The respondents in this group
come from Segment D, where high satisfaction
with their current HCP may be one reason that
they rated OTC hearing aid opportunities low.
Because they do not perceive themselves as
having an unmet need, they may not have
perceived value in an OTC solution. Whether
they might perceive OTC hearing aids as
meeting their needs in the future when they
look to replace their hearing aids remains to
be seen.

EMERGING TECHNOLOGIES, MARKET SEGMENTS, AND MARKETRAK 10 INSIGHTS/EDWARDS 45

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MarkeTrak 10 also queried 2,141 individu-
als who self-identified as having a hearing loss
but do not own a hearing aid. The majority of
this group said that if OTC hearing aids were
available, they would still be likely to purchase a
hearing aid through an HCP rather than pur-
chase an OTC hearing aid, with only 22% saying
that they probably or definitely would purchase
anOTChearingaid(seeFig.6).Fig.7showsthe
breakdown of responses by age and gender, with
little difference across groups.

To understand why people responded the
way they did to the OTC hearing aid purchase
likelihood question, MarkeTrak 10 also asked
questions about their level of comfort doing
hearing device–related tasks themselves and
their attitudes toward HCPs.

When 3,113 respondents who had hearing
difficulty were asked how comfortable they
would be doing a variety of tasks without the
help of an HCP, approximately one-third to
one-half of the people responded that they were
not very comfortable or not comfortable at all
doing the tasks on their own. These tasks were
assessing their hearing loss, selecting an appro-
priate hearing aid, getting started with the
hearing aids, using features to adjust their
hearing aids, learning/maintaining their hear-
ing aids, and troubleshooting (see Fig. 8). In-
terestingly, people were most comfortable with
cleaning and maintaining their hearing aids,
which may be due to a lack of awareness of
what is required to maintain a hearing aid. Since
the majority of respondents to these questions

Figure 4 MarkeTrak 10 data showing responses from 963 hearing aid owners to: “If the option to purchase
‘over the counter,’ without a requirement to be assessed by a hearing care professional first, had been
available when you purchased your hearing aids through a professional, how do you think you would have
purchased?”

Figure 5 Data from Figure 4 separated by age and gender.

46 SEMINARS IN HEARING/VOLUME 41, NUMBER 1 2020

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were hearing aid nonowners, they were likely
unaware of what is necessary to succeed in doing
any of these tasks. Fig. 9 shows the breakdown
of responses by age and gender, showing that
the level of comfort with these tasks was highest
for those younger than 65 years and males.

MarkeTrak 10 asked current hearing aid
owners how much their HCP helped with the
process of selecting, getting used to, and using
their hearing aids. Sixty-nine percent of the
respondents said that they received a great deal
of help, while another 21% said that they

Figure 6 MarkeTrak 10 data showing responses from 2,141 current hearing aid nonowners to: “Assume you
decided to get hearing aids and the option to purchase ‘over the counter,’ without the current requirement to
be assessed by a hearing care professional first, was available. How do you think you would purchase?”

Figure 7 Data from Figure 6 separated by age and gender.

Figure 8 Responses from 3,113 people who self-report as having hearing difficulty to “How comfortable are
you or would you be doing the following on your own, without the assistance of a hearing care professional?”

EMERGING TECHNOLOGIES, MARKET SEGMENTS, AND MARKETRAK 10 INSIGHTS/EDWARDS 47

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received a moderate amount of help (see
Fig. 10). When the results are broken down
by age and gender, appreciation for the HCP
increases with age, but there is no difference in
gender (see Fig. 11).

A related question was given to people with
hearing difficulty who had obtained hearing
devices through means other than an HCP.
These devices could be noncompliant hearing
aids obtained through the mail or could be
devices intended to help with hearing but not
treat hearing loss. This group of people is
labeled PSAP (personal sound amplification
product) owners. Of the 193 PSAP owners
polled, 66% said that they feel they would
have benefited from an HCP in selecting,
getting used to, and using their PSAPs, with
only 3% saying that they would not have
benefited at all (see Fig. 12). These data suggest
that even if people do not have experience with

HCPs, they realize that the HCP can make a
difference in hearing help.

MarkeTrak Over-the-Counter Results
Discussion
There are likely several reasons why the Marke-
Trak 10 data showed that the majority of
respondents stated a preference to see an
HCP for their hearing health rather than select
an OTC solution. Of primary concern could be
their attitude toward the severity of their hear-
ing loss and the need to see a health care
professional about a health issue. The respon-
dents who were hearing aid owners have expe-
rience with their HCP and their response could
be based on their perception of the capabilities
and skills that the HCP brought to helping
them with their hearing. The group who were
not owners of hearing aids has less or no

Figure 9 Data from Figure 8 broken down by age and gender.

Figure 10 MarkeTrak 10 data showing responses from 960 current hearing aid owners to: “Given your
experience working with a hearing care professional during the process of selecting, getting used to, and
using your hearing aid(s), how much, if at all, did they help you along the way?”

48 SEMINARS IN HEARING/VOLUME 41, NUMBER 1 2020

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experience with HCPs, but, regardless, they
might still have an expectation of the benefit
that an HCP would bring. Hearing loss is a
health care issue and it would not be surprising
that many people generally are more comfort-
able seeing a health care professional for health-
related issues. The fact that they self-report
having hearing difficulty yet are not hearing aid
owners does not necessarily reflect an unwill-
ingness to see an HCP but could be because of
many of the other reasons for not getting
hearing aids discussed earlier, such as stigma
or lack of social support.

On the other hand, the fact that PSAP
owners reported that they would have benefited
from an HCP does not necessarily mean that
they are open to seeing an HCP for hearing
help; many of us likely believe that we would
benefit from some professional help in things
that we do ourselves (fitness routines, setting up
home entertainment systems) even though we
do not actually seek professional help for those
activities. What the data from Figs. 10 and 12
show is that lack of perceived benefit from an
HCP is unlikely to be a reason that most people
with hearing difficulty do not have hearing aids.

Figure 11 Data from Figure 10 separated by age and gender.

Figure 12 MarkeTrak 10 data showing responses from 193 current PSAP owners to: “Given your experience
selecting, getting used to, and using your hearing device or personal amplifier, that you got directly, on your
own, how much, if at all, do you feel you would have benefited from having a hearing care professional help
you along the way?”

EMERGING TECHNOLOGIES, MARKET SEGMENTS, AND MARKETRAK 10 INSIGHTS/EDWARDS 49

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The MarkeTrak 10 respondents with hearing
difficulty but no hearing aids consist of people
from the HD-NHL and HD-HL groups (Seg-
ments C and E from Fig. 1, respectively), and
each of these segments have unmet needs that
traditional HCP-provided hearing aids may not
be solving.

The concept of an OTC hearing aid was not
fullydetailedinMarkeTrak10beforepeoplewere
asked questions about OTC hearing aids. The
information presented was intended to be a very
high-level category concept gauge—not as an
assessment of a specific marketing or sales pitch
(sincetheapproachwillvarydramaticallyasactual
products and brands are more fully developed and
marketed). The respondents were informed that
OTC hearing aids did not involve an HCP and
were lower in cost but were left on their own to
imagine such things as what OTC hearing aids
look like, what the process would be to fit them,
and whether a complicated hearing test would be
needed for use. It is possible that when presented
with an actual OTC hearing aid and tangible
information about it—with possibly a trusted
brand on the device, compelling marketing mes-
sages about benefit and ease of fit, some sort of
“FDA-approved” messaging on the packaging,
andanactualpricethatcanbeassessedforvalue—
intenttopurchaseattitudesshowninFigs.4and6
might change. Comfort with doing hearing de-
vice–related tasks shown in Fig. 8 also might
improve with appropriate marketing, packaging,
and training materials provided.46

With respect to the pending OTC hearing
aid market, these results tell us that the majority
of the potential customers for OTC hearing
aids currently view HCPs favorably and are not
going to seek self-fitting hearing aids solely
because they believe HCPs are unnecessary.
The majority of potential customers also have
concerns about their ability to manage the
various aspects of getting, fitting, and using
OTC hearing aids, which will be a barrier that
needs to be overcome by those selling OTC
hearing aids. Other potential barriers also exist,
as will now be discussed.

OVER-THE-COUNTER CHALLENGES
The creation of an OTC hearing aid category
will address one of the major challenges that has

been faced by traditional consumer electronics
companies considering entering the hearing aid
market, which has been the unique distribution
requirements of selling to a variety of HCPs,
from large chains to individual practices, with
different regulatory requirements in different
states. This unique distribution channel requi-
res sales, marketing, and training forces differ-
ent from those of typical consumer electronics
companies. Competing successfully in the hear-
ing aid market, then, has been a challenge for
many new entrants.

Hearing aids also have unique requirements
to be successful that can be much more difficult
than typical consumer audio products. Marke-
Trak 10foundthathearingaidowners wear their
hearing aids on average 9.9 hours on days that
they were worn. This duration of continuous
wear requires extremely low-power electronics
to enable the devices to last all day without
recharging them (orseveral days beforechanging
batteries if not rechargeable). This also gives a
high priority to comfort, which can be challeng-
ing for a device worn on or in the ear for several
continuous hours each day. Acoustic effects like
occlusion, feedback, and comb filtering also
provide unique challenges to the physical design
of the product. For example, reducing occlusion
typically demands a loose or open fitting, while
reducing feedback requires a tight or closed
fitting. The presence of wax, sweat, humidity,
hairspray,andothermaterialssignificantlyaffect
the reliability of hearing aids such that their
repair and remake rates are much higher than
traditional audio consumer electronics.38 Hear-
ing aid companies have spent decades solving
these problems. While the promotion of new
hearing aid products typically focuses on inno-
vative features such as improved directional
microphones, new signal processing enhance-
ments,andwirelesscapabilities,significanteffort
goes on in quality engineering and manufactur-
ing to ensure that the quality of the product from
a comfort, ease of use, and reliability perspective
is high. These will be some of the challenges
facing new entrants to the OTC hearing aid
marketplace, in a field that typically has high
return, repair, and remake rates and high cus-
tomer support requirements.

While the aforementioned issues will likely
lead to the presence of some OTC hearing aids

50 SEMINARS IN HEARING/VOLUME 41, NUMBER 1 2020

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with unsatisfactory quality and performance,
these challenges are not insurmountable and
eventually there will likely be OTC hearing aids
that have equivalent performance and quality as
HCP-fit hearing aids. The bigger unknown and
possibly more significant challenge will be
issues with the capability of the OTC hearing
aid wearer and the fitting of the device to the
user’s loss.

One open question is what type of person
will be successful with a self-fit hearing aid. In a
study of 60 subjects’ ability to successfully fit
themselves with a hearing aid designed for self-
fitting that would be a candidate for OTC,
Convery et al47 found that only 25% of the
subjects were successful without the help of a
trained assistant; 43% of the subjects were
successful if they received assistance from a
trained clinical assistant, while 32% never achie-
ved success fitting a hearing aid themselves.
Factors that predicted success included cognitive
ability, locus of control, problem-solving skills,
and self-efficacy. Clearly, these results are de-
pendent on the specifics of the design, ease of
use, and training materials for the self-fitting
hearing aid under test, which will vary with
different products. What is clear is that technol-
ogy alone will not determine whether someone
can be successful with an OTC hearing aid.

Another open question is how successful
OTC hearing aid users will be without the
assistance of an HCP. HCPs spend many hours
with hearing aid wearers to make them success-
ful with their devices, providing training,
counseling, and encouragement to overcome
some of the challenges with hearing aid use
and becoming successful hearing aid wearers.
While providing good quality technology, im-
proved audibility and speech understanding are
important for hearing aid success, there are
other factors that influence success with hearing
aids that the HCP can influence, such as
providing positive attitudes to hearing aids
and help with perceived self-efficacy in using
hearing aids.48,49 Several studies have found
that success and satisfaction with hearing aids
were correlated with the perceived care from
and satisfaction with their HCP during the
fitting and counseling process.50–53 These
results indicate that, for those who have re-
ceived HCP-fit hearing aids, the HCP plays an

important role in getting the user to be success-
ful and satisfied with their hearing aids. Lack of
access to an HCP may affect success and
satisfaction with OTC hearing aids, consistent
with findings that those dissatisfied with self-fit
hearing aids became more satisfied and success-
ful with subsequent help from an HCP.54,55

SELF-FITTING TECHNOLOGY
Another challenge will be the fitting of the
OTC hearing aids to the hearing loss of the
user. In the traditional hearing aid world,
significant effort is placed in fitting the gain
and compression ratio to the audiogram of the
client and then fine-tuning those features based
on client feedback. OTC hearing aids could
come with fitting software or apps that allow
people to measure their own audiograms from
which gain and compression can be prescribed,
or the user could individualize the gain and
compression in a completely different way that
does not require a hearing test.

Self-measurement of hearing thresholds is
a feasible approach if the usability of the inter-
face is well designed.56–58 In a quiet room with
proper interface controls, a person can reason-
ably adjust the sound level of a tone until it is
near the threshold of audibility. For the purpo-
ses of an OTC hearing aid used by someone
with mild-moderate hearing loss, precisely
measured thresholds are unlikely to be neces-
sary. Once hearing thresholds are measured
with, say, a smartphone app, a fitting prescrip-
tion such as NAL-NL2 or DSL-I/O could be
used in the app to program the gain and
compression of the hearing aids through a
wireless connection. Thus, the self-measure-
ment of hearing thresholds and application of a
fitting prescription could be one way to person-
alize an OTC hearing aid.

Another method could be to forgo mea-
suring the consumer’s hearing ability and to
simply allow them to adjust the hearing aid
features until some preferred setting is selected.
This could be accomplished through selecting
one of several presets offered or the provision of
an interface that allows the user to adjust the
gain and compression parameters themselves.
The latter has been proven to be successful with
several different approaches.59,60

EMERGING TECHNOLOGIES, MARKET SEGMENTS, AND MARKETRAK 10 INSIGHTS/EDWARDS 51

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Other approaches to user-selected settings
exist and new ones will be developed, sugges-
ting that users can get to a satisfactory setting
for their hearing aids without the intervention
of a professional if the self-tuning software is
well designed and the user capable. A restriction
of OTC hearing aids to mild-moderate per-
ceived losses, as intended with the OTC legis-
lation, will restrict the range of gain and
compression ratios that these methods will
need to make available for selection.

CONCLUSION
The introduction of new hearing health prod-
uct categories will allow for an expansion of
the viable market for hearing care by addres-
sing the unmet needs of different consumer
segments. Those with self-reported hearing
difficulty but no audiometric hearing loss are
potential consumers for hearable devices.
OTC hearing aids will open the market to
those with audiometric hearing loss and a self-
perceived need for hearing help who have, for
whatever reason, rejected HCP-fit hearing
aids as a solution. Those with an audiometric
hearing loss but no self-perceived difficulty,
which appears to be a large segment of the
total population with an audiometric hearing
loss, should not be considered candidates for
hearing aids or other hearing solutions/deliv-
ery methods described in this article because
they do not have a self-perceived need or are
not ready, willing, or able to admit it. The
viable hearing aid market is thus smaller than
previously estimated.

Whether OTC hearing aids are able to
overcome barriers to acceptance of hearing
solutions beyond accessibility and affordability,
such as stigma and perceived self-efficacy,
remains to be seen. MarkeTrak data show
that there is concern among people with hear-
ing difficulty over whether they can manage
some of the steps necessary to select and fit a
hearing aid without the assistance of an HCP.
Data also suggest that HCPs play a significant
role in making a hearing aid wearer a successful
and satisfied user. Whether OTC devices will
provide solutions that overcome some of the
barriers to being a successful user also remains
to be seen.

CONFLICT OF INTEREST

There are no conflicts of interest.

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2. Sarampalis A, Kalluri S, Edwards B, Hafter E.
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