Emerging Technologies, Market Segments, and …...Emerging Technologies, Market Segments, and MarkeTrak 10 Insights in Hearing Health Technology Brent Edwards, Ph.D.1 ABSTRACT Hearing

Emerging Technologies, Market Segments,and MarkeTrak 10 Insights in HearingHealth Technology

Brent Edwards, Ph.D.1

ABSTRACT

Hearing health care is rapidly changing through innovation intechnology, services, business models, and product categories. Theintroduction of hearables and over-the-counter (OTC) hearing aidsin particular will change the market for hearing help and the role of thehearing care professionals (HCPs). This article focuses on how theseproducts will be differentiated fromHCP-fit hearing aids through theirability to address the unmet needs of different consumer segmentswithin the population of people with hearing dysfunction. The unmethearing needs of each segment are discussed, and the size of eachsegment estimated, demonstrating a large potential market for hearablesand a smaller potential market for hearing aids than has been previouslymentioned in the literature. The results fromMarkeTrak 10’s survey ofconsumers’ attitudes toward an OTCmodel are reviewed, showing thatapproximately half of both hearing aid owners and nonowners areuncomfortable doing hearing- and hearing aid–related tasks on theirown without the assistance of an HCP and would be unlikely topurchase OTC hearing aids if available today. MarkeTrak data are alsoshown that demonstrate that the majority of hearing aid and personalsound amplification product owners believe that the HCP helped orwould have helped with their hearing devices. Finally, challenges toOTC 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 UniversityAvenue, Macquarie University, NSW 2109, Australia(e-mail: [email protected]).

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

Semin Hear 2020;41:37–54. Copyright# 2020 by ThiemeMedical 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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INNOVATION IN HEARING AIDSInnovation is anything that creates value innew ways. This is typically embodied in thecreation of a new product, service, process, orbusiness model that addresses unmet needs ofa person or organization.1 By this definition,innovation has had a significant impact onhearing health care over the past two decadesand is continuing to change the hearing healthcare landscape.

This changing hearing health care land-scape has been followed over the past 30 yearsthrough the MarkeTrak series of surveys. TheMarkeTrak research has documented much ofthe changes in terms of the market penetration,consumer views on technology, satisfactionwith professional services, and the core tech-nology of hearing instruments. The latestsurvey, MarkeTrak 10, has provided additionalinsights in these topics and will be explored aswe examine the innovation and trends in thehearing health care space.

Much of the hearing health innovation overthe past two decades has been in the form oftechnology. Two technology platforms in par-ticular transformed the hearing aid technologicallandscape by enabling a series of innovations thatmet the unmet needs of those with hearing lossand hearing care providers (HCPs). The intro-duction of digital signal processing (DSP) in ahearing aid in 1996 and of programmable DSPin 1999 allowed for the rapid development andimplementation of sophisticated signal proces-sing features such as feedback cancellation, noisereduction, frequency lowering, data logging, andothers. These innovations improved the audibil-ity, sound quality, speech understanding, andusability of hearing aids when fit and adjustedproperly, with secondary benefits such as re-duced cognitive load,2,3 mental fatigue,4 andreduced social isolation.5 In 2004, the introduc-tion of wireless technology led to the develop-ment of innovative features such as streamingsound between hearing aids and consumer elec-tronics products, connectivity between hearingaids and smartphones that enabled apps to givegreater hearing aid control to the user, anddata sharing between left- and right-worn hear-ing aids that enabled beamforming and othersophisticated signal processing benefits for hear-ing aid wearers.6,7

In recent years, innovation has expandedbeyond technology into services, businessmodels, and product categories for new marketsegments.

Teleaudiology, or more broadly “connectedhearing health,” is allowing HCPs to providehearing health services to their clients remotely.Innovation in this area has allowed for theprovision of traditional audiological servicesto a patient in a remote location, improvingaccessibility to hearing health services.8 Con-nected hearing health is also improving theconnection between patient and HCP by allo-wing the HCP to provide follow-up serviceslike counseling and hearing aid fine-tuningremotely, eliminating the need for an officevisit while also giving the opportunity for fasterand more frequent service delivery.9

Innovation in hearing aid distributionmodels is disrupting the traditional way onegets a hearing aid, which historically has beento visit anHCP’s office to have one’s hearing lossmeasured and be fit with a hearing aid. Whilemail order hearing aids and online hearing testshave existed for well over a decade,10 some ofthose were distributed in violation of Food andDrug Administration (FDA) and state regula-tions. A new generation of hearing aids is nowbeing distributed that meet FDA and stateregulations, involving audiologists in the deliv-ery process via online or telephone communica-tion, following Good Manufacturing Practices,producing proper labeling on the products, andfollowing other medical device regulations forhearing aids. Hybrid approaches to hearing aiddistribution also are emerging,where audiologistservices are provided online or by phone and thehearing aid ismailed to the userwith instructionsfor self-fitting, while still allowing for the possi-bility of an in-person visit to anHCP’s office andface-to-face professional assistance.11 Peoplecan even test their hearing on their own withan FDA-approved hearing screening system,12

and smartphone apps can do a reasonable job atmeasuring pure-tone thresholds in a quietenvironment.13

Innovation in new product categories ishelping to develop new market segments. Hea-rables, or ear-level worn earpieces with wirelessconnectivity,14 have been developed that aremultifunctional, providing wireless audio

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connections to devices like smartphones andremote microphones, sensors that measure bio-logical function, microphones that enhance andaugment environmental sounds, and more. Hea-rables are not medical devices regulated by theFDA because they are not intended for use in thetreatment of hearing loss, and as such theirdistributors and manufacturers do not have tofollow the requirements that those for hearingaids do. As technology typically associated withhearing aids, such as directional microphones ornoise reduction, starts to appear in hearabledevices, whether a device is a hearing aid or ahearable will becomemore difficult to determine.Ultimately, the same physical device could beeither a hearing aid or a hearable andwhich one itis 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 ofservice and business model innovations thatdevelop new hearing market segments withthe coming creation of an over-the-counter(OTC) hearing aid category by the FDA. TheseOTC hearing aids may expand the reach ofhearing health care by meeting the unmet needsof a segment of people with hearing loss who,until now, have rejected traditional hearing aidsas a solution.

OVER-THE-COUNTER HEARING AIDLEGISLATIONTwo reports were influential in promoting thecreation of an OTC category of hearing aids—the President’s Counsel of Advisors on Scienceand Technology (PCAST) report15 and theNational Academy of Sciences, Engineeringand Medicine (NAS) report.16 Both of thesereports noted that affordability and accessibilitywere significant barriers to some people gettinghearing aids. As a response, the Over-the-Counter Hearing Aid Act of 2017 mandatedthat the FDA create an OTC category forhearing aids that is intended for adults withmild-moderate losses whereby the OTChearing aids could be acquired without theinvolvement of a licensed professional, as man-dated by many state regulations.17 These OTChearing 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 yearsthrough the Internet and other channelswithoutthe involvement of licensed professionals incontrast to claims of poor accessibility andaffordability of hearing aids. (At the time ofthis writing, a search onAmazon andGoogle for“cheap hearing aid” produces a list of manyhearing aids that canbebought online for around$100 or less.) Regardless, the OTC hearing aidlaw will allow organizations to legally sell hear-ing aids directly to consumers that it might nothave otherwise, as long as those organizationsabide by the regulations set by the FDA. Thebenefit to the consumer will be knowing thatthose hearing aids havemet FDAmedical devicerequirements such as being manufactured undera proper quality management system, will haveappropriate labeling on the products, and meetother requirements without being in violation ofstate regulations requiring the involvement ofcertified professionals.

The OTCHearing Aid Act of 2017 requi-res the FDA to create an OTC hearing aidcategory and issue regulations on them byAugust 2020.

MARKET SEGMENTATIONWith these emerging new categories of hearingdevices that could potentially have similar, ifnot identical, features, the question arises ofhow to differentiate between hearables, HCP-fit hearing aids, and OTC hearing aids. Oneway to determine the differences between theseproducts is to consider for which populationgroups 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 areto be successful, what unmet needswill theymeetandwhoseneedswill thosebe?Consider the totalpopulation of people with some sort of auditorydysfunction, whether due to audiometric hearingloss, central auditory nervous system issues, orother deficits.18 A reasonable premise is that thispopulation has unique hearing needs that couldbe helped by those innovative solutions.

This population of people with auditorydysfunction can be segmented into distinctgroups of people with different characteristicsand potentially different hearing needs. Fig. 1

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shows one possible segmentation for this pop-ulation. Each segment is characterized bywhether someone self-identifies as having hear-ing difficulty (HD) or not (NHD), and whethersomeone has an audiometric hearing loss (HL)or not (NHL). Of the HD-HL group—thosewho self-identify as having hearing difficultyand who also have an audiometric hearingloss—a further segmentation can be made onwhether they have accepted HCP-fit hearingaids 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 hearingneeds that may be met by different hearingsolutions.

No Hearing Difficulty GroupSegments A and B in Fig. 1, the NHD-NHLand NHD-HL groups, respectively, representthose with some form of auditory dysfunctionbut who do not self-identify as having hearingdifficulty. In other words, for whatever reasonthey do not have a normal auditory system, butthey do not perceive themselves as having ahearing problem.

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

Segment B, the NHD-HL group, is par-ticularly interesting because they do have ameasurable hearing loss yet do not self-identityas having hearing difficulty. Reasons for theirlack of self-perceived hearing difficulty could bebecause they have a lifestyle that does notrequire listening in difficult situations andtherefore they have not experienced any hearingdifficulty, they are successfully compensatingfor loss of audibility through extra cognitiveeffort, or they lack general self-awareness oftheir situation or condition.19–21 (This groupdoes not include those who are personally awarebut will not admit they have hearing difficultyto others.) Regardless of why, they do notbelieve that they have hearing difficulty andare likely unaware that they have an audiometrichearing loss. This group might benefit from

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

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

When considering the viable market forhearing aids or hearing help, neither theNHD-NHL group nor the NHD-HL groupshould be included. More specifically, estimatesof how many people who need hearing aids butdo not have them should not include the NHD-HLpopulation even though they have a measur-able hearing loss.22 The populations in SegmentsA and B, however, are potential customers forconsumer audio products such as headphones,earphones, or other audio devices that addressother hearing needs such as access to music,podcasts, augmented audio, and other offeringsthat aremarketed to peoplewith normal hearing.

Hearing Difficulty, No Hearing LossGroupSegment C in Fig. 1 is the HD-NHL group.These are people who self-identify as havinghearing difficulty but have audiometrically nor-mal hearing.Manypeoplewithin this populationpresent at audiology clinics but are offered nohelp because they are not diagnosed with ahearing loss. Hearing aids, whose primary func-tion is to improve audibility through the provi-sion of gain, are presumed not to be a solution forthis population since audibility as measured bythe audiogram is not compromised. People inthis segment may have a variety of reasons whythey have difficulty hearing, including auditoryprocessing disorder, cognitive dysfunction,attention-deficit disorder, and synaptopathy.23,24

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

an issue. Their needs are primarily with speechunderstanding and theymay benefit fromdevicesthat improve the speech-to-noise ratio or providesome other mechanism for improving theunderstanding of their speech target, whetherit is the speech of someone in person, on atelevision, or on a phone. Thus, persons in theHD-NHL segment are potential candidates forhearables, which are not intended to compensatefor hearing loss but to improve hearing ability insome way other than the provision of amplifica-tion.Whether any specific person in this group isa candidate for any specific hearable device willdepend onwhether that device has capabilities tomeet the individual needs of the person.

The HD-NHL population should not beconsidered part of the viable market for hearingaids, whether OTC or HCP delivered, becausethey are considered to have normal audibilitythat is assumed to be a prerequisite for needingthe amplification of a hearing aid.

Hearing Difficulty, Hearing Loss GroupSegments D and E make up the HD-HLgroup—those who self-identity as having hear-ing difficulty and also have audiometric hearingloss. This group is the target market for hearingaids because they have audibility issues thatcould benefit from gain and they have a self-recognized need.

The HD-HL group in Segment D consistsof traditional hearing aid wearers, meaning thatthey had their hearing tested by an HCP andwere fit with hearing aids. While they may havedelayed obtaining hearing aids once they real-ized that they had a need, they did not reject thetraditional approach to obtaining hearing helpfrom an HCP and a hearing aid.

TheHD-HLgroup inSegmentE,however,have not pursued hearing aids through an HCPeven though they have an audiometric loss andself-identify as having a need to hear better.There are many reasons that someone wouldhave treatable hearing loss and know that theyhave hearing difficulty yet still not pursue asolution. The PCAST and NAS reports suggestthat accessibility and affordability are two of themain reasons. Additional reasons include stigmaeffects, lack of awareness of how to take action,lack of belief that hearing aids can be beneficial,

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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 helpsthem make a decision to get a hearing aid bymeeting such unique needs as affordability,accessibility, confidence in treatment success, oreliminating stigma. For those in this segmentwho have not obtained a hearing aid from anHCP because of affordability and accessibility,OTC hearing aids are attractive as a hearinghealth solution. OTC hearing aids will not defacto address any of the other reasons that causepeople in this group to not get a hearing aidthrough an HCP, although positive brand rec-ognition and effective direct-to-consumer mar-keting could address such issues as lack of a beliefof benefit from hearing aids or lack of supportfrom significant others.

Thus, each segment has different hearinghelp needs that could be addressed by differenthearing device solutions. Knowing this wouldhelp estimate the size of the market for eachsolution: hearables, HCP-fit hearing aids, andOTC hearing aids.

POPULATION SEGMENTESTIMATESWhile there has been no attempt to estimate thepopulation size within each segment withinFig. 1 with a consistent criterion for each, therehave been independent attempts to estimate thepopulation size of individual segments or thesumof a subset of the segments. For example, theprevalence of hearing loss in adults has beenestimated from both self-reported data and fromaudiometric hearing loss data, that is, eitherestimates of the sum of Segments C, D, and Eor the sumof segments B,D, andE, respectively.Combining these estimates with estimates ofindividual segments, one can use simple arith-metic to estimate the population size of seg-ments for which there are no data. While thecriteria with which people are associated witheach segment for the purpose of estimatingpopulation size are not consistent (e.g., criteriafor no hearing loss, criteria for self-identifying ashaving hearing difficulty, or age criteria consid-ered for the estimates), we can still attempt toestimate the size of each segment from varioussources.

Several estimates exist for the size of thetotal adult population who self-report as havinghearing difficulty (i.e., the sum of Segments C,D, and E or the sum of the HD-NHL and theHD-HLpopulations).MarkeTrak 10 has foundthat 10.8% of all respondents (n¼ 55,650), with13.1% of adults, self-report as having hearingdifficulty,which is 32.6millionpeople basedon atotal U.S. adult population of 249.2 million in2018.29 Blackwell et al30 estimated the percent-age of adults who had hearing difficulty to be15%, which is 37.4 million. A challenge witheach of the different population estimates is thecriteria used. They rely on self-reported data butused different questions on which to make thedetermination that someone perceives them-selves to have hearing difficulty.

Similarly, several estimates have been madeon the population size of adults with audiometrichearing loss (the sum of Segments B, D, and E).Goman andLin31 recently estimated the numberof people in the United States aged 20 and overwith audiometric hearing loss to be 38.1 million.We can safely assume that the number of peopleaged 18 and older also to be 38.1 million as wellsince the number of people aged 12 to 19 withhearing loss is only 0.06 million.31 With a totaladult population size of 249.2 million and a totaladult HL population size of 38.1 million, thetotalNHLpopulation sizemust be thedifferenceor 211.1 million.

Several estimates exist for the size of thepopulation of people with normal audiometrichearingbut self-reportedhearingdifficulty (Seg-ment C), varying from 20% of the NHL popu-lation32 or 42.2 million people, to 29% of theNHL population33 or 61.2 million people, to arange of 20 to 40% of the NHL population34 or42.2 to 84.4 million people. Tremblay et al,35

using a much stricter criteria for normal audio-metric hearing of pure-tone thresholds less than20 dB HL at 0.5, 1, 2, 3, 4, 6, and 8 kHz, foundthat 12% of a cross-section population of theBeaver Dam Offspring Study had self-reportedhearing difficulty, which would be 25.3 millionout of the 211.1 million NHL adults referencedearlier. These different HD-NHL populationsize estimates vary in large part due to thedifferences in criteria used to classify someoneas having no audiometric hearing loss andhavingself-reported hearing difficulty. Note also that

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these estimates for the size of Segment C exceedthe aforementioned estimates for the size of thesum of Segments C, D, and E, which is mathe-matically inconsistent. Again, the challenge incomparing these population estimates is the lackof consistency in criteria. In order for the esti-mate of the HD-NHL (Segment C) populationsize to be reasonably smaller than the estimate ofthe total HD (the sum of segments C,D, and E)population size, we will use the smaller popula-tion estimate of 25.3million fromTremblay et alfor the HD-NHL group and the larger popula-tion estimate of 37.4million fromBlackwell et alfor the HD group.

There have been many attempts to estimatethe population size of HD-HL adults who wearhearing aids, Segment D. Chien and Lin36

estimated the number of people over 50 whohave hearing aids to be 3.8 million based onNHANESdata,which is an incomplete estimateof the total adult population who wears hearingaids in theUnited States since it does not includepeople younger than 50 years. Popelka et al37

estimated the percentage of people with hearingloss in their worst ear who have hearing aids to be14.6%. Applying this percentage to the Gomanand Lin’s estimate of 60.1 million people withaudiometric loss in at least one ear31 gives anestimate of 8.8 million people with hearing aids,although Popelka et al’s estimate is for the totalpopulation, not just adults. MarkeTrak 10 esti-mates that 3.7% of the total population have ahearing aid, resulting in an estimate of 12millionpeople. Again, this number is for the totalpopulation, not just adults. MarkeTrak 9 esti-mated that less than 1% of the populationyounger than 18 years had a hearing aid whichis 0.7 million people, which would put the totaladults with hearing aids at over 11.3 millionpeople.

We can cross-check these hearing aid ownernumbers with the number of hearing aids sold ina year. Given that an average duration someonekeeps a hearing aid before replacing it with a newone is approximately 5 years, one could estimatethe population size of hearing aid wearers bysumming the number of hearing aids sold overthe past 5 years. This totals 17.9 million devi-ces.38–42Over 90%ofpeoplefitwithhearing aidsare fit with two devices,43 which means that17.9 million hearing aids were fit on at least 9.4

million people over the past 5 years. If wesubtract the estimate of 0.7 million people under18 who have hearing aids from this number, theestimate for adultswithhearing aids becomes 8.7million, which is remarkably close to the 8.8million derived from the data of Popelka et alandGorman and Lin. This number, of course, isnot exact because there were some people whobought their hearing aidswithin that time periodwho replaced them with new devices before theend of 2018, which would decrease the popula-tion estimate. Additionally, there are people stillwearing their hearing aids who acquired themmore than 5 years ago, which would increase thepopulation estimate. There are also people whopurchased hearing aids in that time period whohave died. Despite these additional uncertain-ties,wewill use the estimate of 8.7millionpeoplefor the HD-HL group with hearing aids.

Fig. 2 shows the adult population segmentsassuming 8.7 million hearing aid wearers, 25.3million in the HD-NHL population, 38.1million in the total HL group, and 37.4 millionin the total HD group. Population estimates ofSegments E and B can be calculated to keepmathematical consistency with these definedconstraints. This results in an estimate ofpopulation size in Segment E, or the HD-NHL population who do not have hearingaids, 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 theassumptions of the population sizes for theother population segments and can thereforechange dramatically if one or more of the othersegment size estimates change.

Oneof themost problematic assumptions inthe creation of the segment population in Fig. 3was the size of the totalHDpopulation (the sumof Segments C, D, and E) because many of thepopulation estimates forSegmentCalone excee-ded the population estimates for the sum ofSegments C, D, and E, which cannot be valid.One could argue that a larger number shouldhave been used for the sum of Segments C, D,andE than 38.2million. If an estimate of, say, 50million were used, then the estimate for thepopulation of Segment E would be 16 millioninstead of 3.4 million. The 3.4 million number

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Figure 2 Estimated U.S. adult population numbers for those with self-reported hearing difficulty and noaudiometric hearing loss (C), those who are hearing aid owners (D), the total population with audiometrichearing loss in both ears (BþDþE), and the total population with self-reported hearing difficulty (CþDþE).Numbers represent millions.

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

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seems low considering that Kochkin44 estimatedthat there were 8.8 million people withouthearing aids who had a similar hearing losscomposite score as those with hearing aids.This is important because the total viable hearingaidmarket is assumed to be the sum of SegmentsD and E, and the potential OTCmarket can beestimated to be at least the size of Segment E.

So, after all of this, what can be said aboutthe potential market size for hearables andOTC hearing aids? The population for whomhearables may address an unmet need is theHD-NHL group, which has been estimatedto be at least 25.3 million adults in the UnitedStates. This is a significant untapped mar-ket—much larger than the population ofcurrent hearing aid wearers. Organizationslooking to provide solutions with hearablesdo not need to focus on current hearing aidwearers as their target market, since theyappear to be happy with their hearing aidsand HCP as will be discussed later, but focuson addressing the unique unmet needs of theHD-NHL group.

The potential market for OTC hearingaids is at least the population in Segment E,the HD-HL group without hearing aids.Possible customers also could include peoplein Segment D, the HD-HL group withhearing aids. Whether people in Segment Dhave a need for such a device remains to beseen and will be investigated in the nextsection. What is clear is that the people inSegment B, the NHD-HL group, are unlikelyto be candidates for OTC devices primarilybecause they do not self-perceive as having ahearing problem and therefore OTC hearingaids will not address any need for people inthis population. Using the numbers in Fig. 3,72% of those who could benefit from a hearingaid 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 losshave no self-perceived hearing difficulty, sim-ilar to the 66% number found for the percent-age of Canadians aged 40 to 79 withmoderate-to-profound high-frequency audio-metric hearing loss who do not self-report ashaving hearing loss,45 albeit using a differentcriteria for audiometric hearing loss.

MARKETRAK OVER-THE-COUNTERRESULTSWith the creation of an OTC category ofhearing aid looming, MarkeTrak 10 askedseveral questions related to the potential successof these devices to meet the unmet needs of theHD population.

The questions about OTC hearing aidswere preceded with the following information:

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

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

MarkeTrak 10 queried 963 individualswho self-identified as having a hearing difficul-ty and who currently own a hearing aid. Whenasked if they would have purchased an OTChearing aid instead of going to a professional ifthe option had been available to them, few saidthat they would have, with 88% responding thatthey either probably or definitely still wouldhave purchased a hearing aid through an HCP(see Fig. 4). Fig. 5 shows the breakdown ofresponses by age and gender, with little differ-ence across groups, although there was a slighttendency for the youngest age group to respondin the “not sure” category compared with theolder groups. The respondents in this groupcome from Segment D, where high satisfactionwith their current HCP may be one reason thatthey rated OTC hearing aid opportunities low.Because they do not perceive themselves ashaving an unmet need, they may not haveperceived value in an OTC solution. Whetherthey might perceive OTC hearing aids asmeeting their needs in the future when theylook to replace their hearing aids remains tobe seen.

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MarkeTrak 10 also queried 2,141 individu-als who self-identified as having a hearing lossbut do not own a hearing aid. The majority ofthis group said that if OTC hearing aids wereavailable, they would still be likely to purchase ahearing aid through an HCP rather than pur-chase anOTChearing aid, with only 22% sayingthat they probably or definitely would purchaseanOTChearing aid (seeFig. 6). Fig. 7 shows thebreakdown of responses by age and gender, withlittle difference across groups.

To understand why people responded theway they did to the OTC hearing aid purchaselikelihood question, MarkeTrak 10 also askedquestions about their level of comfort doinghearing device–related tasks themselves andtheir attitudes toward HCPs.

When 3,113 respondents who had hearingdifficulty were asked how comfortable theywould be doing a variety of tasks without thehelp of an HCP, approximately one-third toone-half of the people responded that they werenot very comfortable or not comfortable at alldoing the tasks on their own. These tasks wereassessing their hearing loss, selecting an appro-priate hearing aid, getting started with thehearing aids, using features to adjust theirhearing aids, learning/maintaining their hear-ing aids, and troubleshooting (see Fig. 8). In-terestingly, people were most comfortable withcleaning and maintaining their hearing aids,which may be due to a lack of awareness ofwhat is required tomaintain a hearing aid. Sincethe 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 beenavailable when you purchased your hearing aids through a professional, how do you think you would havepurchased?”

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

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were hearing aid nonowners, they were likelyunaware of what is necessary to succeed in doingany of these tasks. Fig. 9 shows the breakdownof responses by age and gender, showing thatthe level of comfort with these tasks was highestfor those younger than 65 years and males.

MarkeTrak 10 asked current hearing aidowners how much their HCP helped with theprocess of selecting, getting used to, and usingtheir hearing aids. Sixty-nine percent of therespondents said that they received a great dealof help, while another 21% said that they

Figure 6 MarkeTrak 10 data showing responses from 2,141 current hearing aid nonowners to: “Assume youdecided to get hearing aids and the option to purchase ‘over the counter,’ without the current requirement tobe 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 areyou or would you be doing the following on your own, without the assistance of a hearing care professional?”

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received a moderate amount of help (seeFig. 10). When the results are broken downby age and gender, appreciation for the HCPincreases with age, but there is no difference ingender (see Fig. 11).

A related question was given to people withhearing difficulty who had obtained hearingdevices through means other than an HCP.These devices could be noncompliant hearingaids obtained through the mail or could bedevices intended to help with hearing but nottreat hearing loss. This group of people islabeled PSAP (personal sound amplificationproduct) owners. Of the 193 PSAP ownerspolled, 66% said that they feel they wouldhave benefited from an HCP in selecting,getting used to, and using their PSAPs, withonly 3% saying that they would not havebenefited at all (see Fig. 12). These data suggestthat even if people do not have experience with

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

MarkeTrak Over-the-Counter ResultsDiscussionThere are likely several reasons why theMarke-Trak 10 data showed that the majority ofrespondents stated a preference to see anHCP for their hearing health rather than selectan OTC solution. Of primary concern could betheir attitude toward the severity of their hear-ing loss and the need to see a health careprofessional about a health issue. The respon-dents who were hearing aid owners have expe-rience with their HCP and their response couldbe based on their perception of the capabilitiesand skills that the HCP brought to helpingthem with their hearing. The group who werenot 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 yourexperience working with a hearing care professional during the process of selecting, getting used to, andusing your hearing aid(s), how much, if at all, did they help you along the way?”

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experience with HCPs, but, regardless, theymight still have an expectation of the benefitthat an HCP would bring. Hearing loss is ahealth care issue and it would not be surprisingthat many people generally are more comfort-able seeing a health care professional for health-related issues. The fact that they self-reporthaving hearing difficulty yet are not hearing aidowners does not necessarily reflect an unwill-ingness to see an HCP but could be because ofmany of the other reasons for not gettinghearing aids discussed earlier, such as stigmaor lack of social support.

On the other hand, the fact that PSAPowners reported that they would have benefitedfrom an HCP does not necessarily mean thatthey are open to seeing an HCP for hearinghelp; many of us likely believe that we wouldbenefit from some professional help in thingsthat we do ourselves (fitness routines, setting uphome entertainment systems) even though wedo not actually seek professional help for thoseactivities. What the data from Figs. 10 and 12show is that lack of perceived benefit from anHCP is unlikely to be a reason that most peoplewith 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 experienceselecting, getting used to, and using your hearing device or personal amplifier, that you got directly, on yourown, how much, if at all, do you feel you would have benefited from having a hearing care professional helpyou along the way?”

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The MarkeTrak 10 respondents with hearingdifficulty but no hearing aids consist of peoplefrom the HD-NHL and HD-HL groups (Seg-ments C and E from Fig. 1, respectively), andeach of these segments have unmet needs thattraditional HCP-provided hearing aids may notbe solving.

The concept of an OTC hearing aid was notfully detailed inMarkeTrak10before peoplewereasked questions about OTC hearing aids. Theinformation presented was intended to be a veryhigh-level category concept gauge—not as anassessment of a specific marketing or sales pitch(since the approachwill vary dramatically as actualproducts and brands aremore fully developed andmarketed). The respondents were informed thatOTC hearing aids did not involve an HCP andwere lower in cost but were left on their own toimagine such things as what OTC hearing aidslook like, what the process would be to fit them,and whether a complicated hearing test would beneeded for use. It is possible that when presentedwith an actual OTC hearing aid and tangibleinformation about it—with possibly a trustedbrand on the device, compelling marketing mes-sages about benefit and ease of fit, some sort of“FDA-approved” messaging on the packaging,and an actual price that canbe assessed for value—intent to purchase attitudes shown inFigs. 4 and6might change. Comfort with doing hearing de-vice–related tasks shown in Fig. 8 also mightimprove with appropriate marketing, packaging,and training materials provided.46

With respect to the pending OTC hearingaid market, these results tell us that the majorityof the potential customers for OTC hearingaids currently view HCPs favorably and are notgoing to seek self-fitting hearing aids solelybecause they believe HCPs are unnecessary.The majority of potential customers also haveconcerns about their ability to manage thevarious aspects of getting, fitting, and usingOTC hearing aids, which will be a barrier thatneeds to be overcome by those selling OTChearing aids. Other potential barriers also exist,as will now be discussed.

OVER-THE-COUNTER CHALLENGESThe creation of an OTC hearing aid categorywill address one of the major challenges that has

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

Hearing aids also have unique requirementsto be successful that can be much more difficultthan typical consumer audio products. Marke-Trak 10 found that hearing aid ownerswear theirhearing aids on average 9.9 hours on days thatthey were worn. This duration of continuouswear requires extremely low-power electronicsto enable the devices to last all day withoutrecharging them (or several days before changingbatteries if not rechargeable). This also gives ahigh priority to comfort, which can be challeng-ing for a device worn on or in the ear for severalcontinuous hours each day. Acoustic effects likeocclusion, feedback, and comb filtering alsoprovide unique challenges to the physical designof the product. For example, reducing occlusiontypically demands a loose or open fitting, whilereducing feedback requires a tight or closedfitting. The presence of wax, sweat, humidity,hair spray, andothermaterials significantly affectthe reliability of hearing aids such that theirrepair and remake rates are much higher thantraditional audio consumer electronics.38 Hear-ing aid companies have spent decades solvingthese problems. While the promotion of newhearing aid products typically focuses on inno-vative features such as improved directionalmicrophones, new signal processing enhance-ments, andwireless capabilities, significant effortgoes on in quality engineering and manufactur-ing to ensure that the quality of the product froma comfort, ease of use, and reliability perspectiveis high. These will be some of the challengesfacing new entrants to the OTC hearing aidmarketplace, in a field that typically has highreturn, repair, and remake rates and high cus-tomer support requirements.

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

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with unsatisfactory quality and performance,these challenges are not insurmountable andeventually there will likely be OTC hearing aidsthat have equivalent performance and quality asHCP-fit hearing aids. The bigger unknown andpossibly more significant challenge will beissues with the capability of the OTC hearingaid wearer and the fitting of the device to theuser’s loss.

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

Another open question is how successfulOTC hearing aid users will be without theassistance of an HCP. HCPs spend many hourswith hearing aid wearers to make them success-ful with their devices, providing training,counseling, and encouragement to overcomesome of the challenges with hearing aid useand becoming successful hearing aid wearers.While providing good quality technology, im-proved audibility and speech understanding areimportant for hearing aid success, there areother factors that influence success with hearingaids that the HCP can influence, such asproviding positive attitudes to hearing aidsand help with perceived self-efficacy in usinghearing aids.48,49 Several studies have foundthat success and satisfaction with hearing aidswere correlated with the perceived care fromand satisfaction with their HCP during thefitting and counseling process.50–53 Theseresults 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 ofaccess to an HCP may affect success andsatisfaction with OTC hearing aids, consistentwith findings that those dissatisfied with self-fithearing aids became more satisfied and success-ful with subsequent help from an HCP.54,55

SELF-FITTING TECHNOLOGYAnother challenge will be the fitting of theOTC hearing aids to the hearing loss of theuser. In the traditional hearing aid world,significant effort is placed in fitting the gainand compression ratio to the audiogram of theclient and then fine-tuning those features basedon client feedback. OTC hearing aids couldcome with fitting software or apps that allowpeople to measure their own audiograms fromwhich gain and compression can be prescribed,or the user could individualize the gain andcompression in a completely different way thatdoes not require a hearing test.

Self-measurement of hearing thresholds isa feasible approach if the usability of the inter-face is well designed.56–58 In a quiet room withproper interface controls, a person can reason-ably adjust the sound level of a tone until it isnear the threshold of audibility. For the purpo-ses of an OTC hearing aid used by someonewith mild-moderate hearing loss, preciselymeasured thresholds are unlikely to be neces-sary. Once hearing thresholds are measuredwith, say, a smartphone app, a fitting prescrip-tion such as NAL-NL2 or DSL-I/O could beused in the app to program the gain andcompression of the hearing aids through awireless connection. Thus, the self-measure-ment of hearing thresholds and application of afitting 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 tosimply allow them to adjust the hearing aidfeatures until some preferred setting is selected.This could be accomplished through selectingone of several presets offered or the provision ofan interface that allows the user to adjust thegain and compression parameters themselves.The latter has been proven to be successful withseveral different approaches.59,60

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Other approaches to user-selected settingsexist and new ones will be developed, sugges-ting that users can get to a satisfactory settingfor their hearing aids without the interventionof a professional if the self-tuning software iswell designed and the user capable. A restrictionof OTC hearing aids to mild-moderate per-ceived losses, as intended with the OTC legis-lation, will restrict the range of gain andcompression ratios that these methods willneed to make available for selection.

CONCLUSIONThe introduction of new hearing health prod-uct categories will allow for an expansion ofthe viable market for hearing care by addres-sing the unmet needs of different consumersegments. Those with self-reported hearingdifficulty but no audiometric hearing loss arepotential consumers for hearable devices.OTC hearing aids will open the market tothose with audiometric hearing loss and a self-perceived need for hearing help who have, forwhatever reason, rejected HCP-fit hearingaids as a solution. Those with an audiometrichearing loss but no self-perceived difficulty,which appears to be a large segment of thetotal population with an audiometric hearingloss, should not be considered candidates forhearing aids or other hearing solutions/deliv-ery methods described in this article becausethey do not have a self-perceived need or arenot ready, willing, or able to admit it. Theviable hearing aid market is thus smaller thanpreviously estimated.

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

CONFLICT OF INTEREST

There are no conflicts of interest.

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