Until recently, hearing aids supposedly weren’t able to be purchased over-the-counter (OTC). Instead, consumers had to have a professional evaluate their hearing loss, set the hearing aid’s performance, and teach proper use.  However, recent OTC sales of hearing aid legislation has opened the door to focus on OTC self-fitting of hearing aids.


Why is Self-Fitting of Hearing Aids an Issue?

OTC sales of hearing aids has recently been introduced by legislation at the federal level.  The reason is because statistics from the National Institute of Deafness and other Communication Disorders report that of adults 70 years of age and older, and who could benefit from hearing aids, that fewer than 30 percent have ever used one.  The key word is “used,” not even “own” or “wear.”  In reality, market penetration has been declining for the past two decades or longer, primarily due to increases in the aging population and an inability of the current medical model distribution system to make any significant headways to increase market penetration1.

Many comments have been made by hearing professionals in opposition to OTC (over-the-counter) hearing aid sales, often citing the inability of a hearing-impaired individual to self-fit the product, an activity inherent in OTC sales.

The only problem with such comments is that to the best of knowledge, none of those commenting in opposition to OTC hearing aid sales have ever sold an instrument OTC, have engaged in a self-fit of hearing aids, or conducted a study comparing OTC sales against the traditional medical model.  If they had, they may have been in violation of State and Federal regulations, depending on their sales model.  So, where did they gain their expertise and knowledge in order to comment with such certainty?    


Why Not Ask Those Who Have Such Knowledge?

A review of the Internet shows that many individuals/groups/facilities have been providing OTC hearing aids and or PSAPs (Personal Sound Amplification Products) which are really hearing aids) for a number of years.  A non-intensive and rather quick search of the Internet finds at least 50 different businesses selling PSAPs online.  Quite a large number are also selling hearing aids online.  It is generally implied by hearing professionals that few of such products are sold, and that purchasers have not been satisfied with them.  These comments seem to be based generally on anecdotal reports or wishful thinking.  These implications may very well be true.  But, every audiologist has also heard stories about individuals who have not been satisfied with their premium-priced hearing aids supplied by other hearing professionals.  The industry continues to operate on an approximate 25% to 30% return rate on conventional products, somewhat similar to what personal reports are on OTC/PSAP products.  One has to wonder where the greatest damage occurs – not being satisfied with a premium-priced hearing aid, or with a much less expensive amplification product?  Which of these customers is less likely to try amplification again soon?  Might it be the customer who has already taken the best approach and product the industry has to offer, or someone who still has the option of upgrading?  What is interesting related to this discussion, is that MarkeTrak VIII reported that nearly half (45.3%) of direct-mail consumers previously tried or owned traditional hearing aids.   Additionally, direct-mail consumers wear their hearing aid more than 9 hours a day, the same as traditional hearing aid consumers, but are slightly less likely to place their hearing aid in the drawer (3.0% versus 8.2%).2  The percentage of hearing aid owners who purchased their hearing aid through the mail was 3.28% (280,000 people) in 2010, and 5.1% in 2004.3

A Michigan Ear Institute study on 9 consumers demonstrated that a BTE (behind-the-ear) hearing aid sold by direct mail offered a reasonable low-cost solution to those not wearing hearing aids or amplification devices because of cost concerns.  The study found that the hearing aids met the acoustic targets, and that all participants demonstrated user satisfaction scores within the standard range for consumers with mild to moderately-severe hearing loss.4

As reported previously, in a clinical study of 15 consumers in which traditional hearing aids were compared to fixed-format PSAPs, close approximations to real-ear aided responses occurred.  Additionally, no significant differences in mean performance for aided speech recognition or field ratings of aided performance were found.  Patient satisfaction was lower for the PSAPs, primarily due to fit and comfort of the deep insertion.5

In a preference study of hearing aids versus PSAPs, 20 adult subjects performed as well in this laboratory study as did hearing aids (basic and premium) for everyday noises and music, but not for speech.6  

A 2014 study comparing traditional and direct-mail hearing aid use reported that consumers are willing to make trade-offs in benefit for substantial reductions in price, even though benefit might be less.7  This study has the largest, and essentially only, database that reports on consumer positions over time, and used the customer database (all data and actions anonymous ID# and blinded) of Hearing Help Express of DeKalb, IL, but not conducted by Hearing Help.  The database consisted of all customers for 39 months.  A 6-page MarkeTrak-type survey was mailed to random customers (sample size of 2,332 and 16% return rate).  Customers had been self-fitted, selecting gain, preferred hearing aid style, features, price, and making their own ear impressions if the selection process took them to more severe hearing level requirements.  The did have unlimited access to licensed hearing aid dispensers for recommendations, if needed.  This was mostly phone contact.  Customer comparisons of this population were made to various MarkeTrak data of consumers who purchased their hearing aids via the traditional hearing professional hearing aid distribution system.  Interestingly, in the Hearing Help Express population, almost half (45.3%) were previous traditional hearing aid users.  5.6% had previously tried (purchased/tried) OTC hearing aids, and about one-fifth (18.8%) were previous customers of other direct-mail firms.  The direct-mail consumer had been a hearing aid user significantly longer than the traditional hearing aid user (14.2 versus 9.6 years).

The out-of-pocket cost per hearing aid to the direct-mail consumer was $299 compared to $1,500 for the traditional user (after 3rd party pay and VA aid costs had been deducted for the latter).  Data suggested that the direct-mail owner was slightly less likely to place their hearing aid in the drawer (3% versus 8.2%), more likely to recommend hearing aids to others (91% versus 82%), and have greater brand loyalty.  Because these percentages did not meet the study 10 percentage point criterion difference, they should be reviewed in that light.  Additionally, overall satisfaction and perceived benefit by consumers were nearly equivalent, with direct-mail consumers rating their hearing aid significantly higher on value (79% versus 65%).  Other scores on listening and sound quality were somewhat similar between the groups, but both groups rated poor performance in noisy situations at a rate of about 30%.  The most spectacular hearing handicap reduction experiences were related to traditional customers.

A couple of findings require restating and consideration relative to this post’s discussion of OTC hearing aid sales:

  • Almost half (45.3%) of direct-mail consumers had previously tried or owned traditional hearing aids. Does this speak to a disconnect in the current traditional delivery system?
  • Direct-mail consumers were slightly less likely to place their hearing aids in the drawer (3.0% versus 8.2%). Could this be that the expectation was higher with traditional and more-costly hearing aids (speculation only)?
  • About half of non-adopters with serious hearing loss indicated that they would purchase a hearing aid within the next 2 years if the hearing aid was priced under $500.8



As to the number of PSAPs (or similarly-sold amplification products) that have been sold, there are no numbers available – not even good estimates.  Few of the companies are willing to provide their sales numbers and/or revenues, consistent with the practices of most non-public companies.  But, a cursory investigation suggests that the numbers may be much higher than might be generalized.

MarkeTrak 83 estimated that 1.45 million individuals might be wearing PSAPs.  This compared to 10 million owners of hearing aids.  In identifying PSAPs, a liberal definition was used.  As added information, the average income of those purchasing PSAPs was about $10,000 lower than those purchasing from hearing aid retailers.  This survey asked people if they had personal sound amplifiers, using this definition: “a device that amplifies sound that was not fit by a hearing care professional”.

One of the first audiologists to sell PSAPs via mail was Michael Nehr.  Tragically, his activity cost him his business, his freedom, and nearly $10m in legal fees before being vindicated in a court of law.  Michael sold one of the first non-hearing aid PSAPs, Crystal Ear.  Although he always wanted to sell these through the professional channel, he met resistance from that community.  As a result, he started selling Crystal Ear through the mail.  Michael admitted the surprising response of the public to an amplifier sold through ads in publications like Reader’s Digest and Smithsonian Magazine.  Never were these sold as hearing aids and there was enough interest for the company to sell 20,000 per month in the late 1990s and early into 2000.  This was at a time when only 1.5-1.8 million hearing aids were sold in the U.S., not counting an additional 240,000 Crystal Ear’s.

Additional insight into the number of OTC/PSAP unit sales comes from a CNN Moneyline news feature as reported by The Hearing Review, in which CNN reported that Telebrands, the marketers of Whisper XL, sold over 400,000 units in the April-November period of the year the news feature occurred (1994).  If true, Whisper XL, during that time period, would have accounted for approximately 21.5% of the U.S. hearing instruments market.  The product sold for less than $30 and was sold without involvement by hearing care professionals.9  Multiple such products have become available, and with many having substantial advanced technology.  Most of the better products now carry a higher cost, reflecting their improvement, but still ranging in cost from about $50 to $500, with an average price at about $200.  

CEA (Consumer Electronics Association)10 estimated that hearables (very conceivably another form of OTC/PSAP) were estimated to be $50 billion dollars global market by 2018.  This is separate from what is called the traditional hearing aid market.


Preferred Purchase Locations for OTC/PSAP products

Among those that do not currently own a PSAP, over a third of those either diagnosed with hearing loss, or with a lot or some hearing difficulty (39% each), are interested or very interested in purchasing a non-prescription option to hear better.10  Where they would prefer to purchase such non-prescription products is shown in Figure 1.

Figure 1.  Preferred channel for purchasing non-prescription PSAPs (author comment placing PSAPs in the same category as OTE products).  Base: Online U.S. adults with some degree of hearing loss who do not own a PSAP but are interested/very interested in purchasing one (n=334).  Hearing aid dispenser is traditional or audiologist.  Question:  If you were to purchase a non-prescription or ‘over the counter’ device for yourself to help you hear better, where would you be willing to purchase that device?


Over two-thirds (69%) of adult Americans with hearing difficulty, equating to a sizable 68 million people, feel they should be able to buy hearing assistance products the same way they purchase reading glasses, while 63% of those without hearing loss feel the same. Furthermore, just a tenth are opposed to the idea, and a quarter are not sure how they feel about it (Figure 2).5   Hearing professionals argue that no comparison can be made with OTC hearing aids and reading glasses.  Because there is no evidence one way or the other, time will tell, with the consumer being the judge.

Figure 2.  Support for non-prescription hearing assistance products.  Base: Online U.S. adults with some degree of hearing loss (n=1,554); Online U.S. adults with no hearing loss (n=1,870).  Question: Do you think consumers should be allowed to buy hearing assistance products the way they can now buy reading glasses (e.g., through the mail or at a local drug store)?


The Hearing Aid Market is Already Being Disrupted

Internet sales, PSAPs, and mail order of hearing aids have been active for several years (especially some mail order for more than 40 years).  Published customer satisfaction comments are most generally positive.  This is expected because none of these companies are interested in publishing negative comments.  But, this is true also for any of the hearing professional sites.

Big Box stores have had a significant impact in changing where consumers go to purchase hearing aids for a lower cost (for example, Costco with an 11% of the 37% independent hearing aid market share),11 although they have been “sanctioned” by the Hearing Industries Association (HIA) as being an acceptable distribution system because they include the “…professional care inherent to successful adoption of hearing aids.”  HIA goes on to say that OTC sales of hearing aids (implying self-fit, which is a main part of OTC sales) is a bad decision because “no studies have indicated that people can accurately self-diagnosis either the cause or extent of their hearing loss.”12   That statement is just as true as saying that no studies have indicated that people cannot accurately self-diagnose the extent of their hearing loss.  The significance of requiring an audiometric evaluation has not been shown to improve a person’s performance with hearing aids.  And, to the best of knowledge, diagnoses of hearing loss remains under the realm of the physician.  The argument of the significance/insignificance of the audiogram to determine hearing level for successful hearing aid fitting has been discussed already in previous posts.



Marketing is satisfying consumer needs.  Selling is satisfying our needs.  It seems that many consumers are expressing what they are interested in, and we, the hearing professionals keep telling them what we think is good for them.  In the long run, the consumer will win, one way or the other.  The signals of what to consider are blaring, and a substantial population of consumers are interested in an OTC hearing aid delivery system.  A marketer would realize that such a market has a rather large potential and would find ways to service this market segment.  Continuing to beat a floundering horse in a race is a certain pathway to failure.

More on the OTC sales of hearing aids in future posts.



  1. Freeman B. The coming crisis in audiology. Audiology Today. Nov/Dec 2009:46-53.
  2. Kochkin S. (2014). A comparison of consumer satisfaction, subjective benefit, and quality of life changes associated with traditional and direct-mail hearing aid use.  Hearing Review, January.
  3. Kochkin S. MarkeTrak VIII: Utilization of PSAPs and Direct-Mail Hearing Aids by People with Hearing Impairment. The Hearing Review, June 2010; Volume 17, Number 6: Pages 12, 14, 15, & 16.
  4. Hearing Review. Small Study Presented at AAO-HNSF Positively Evaluates OTC Device. October 2, 2012. /all-news/20680-clarificationsmall-study-presented-at-aao-hnsf-positively-evaluates-otc-device.
  5. Walden TC, Walden BE, Cord MT. (2002). Performance of traditional versus fixed-format hearing aids for precipitously sloping high-frequency hearing loss. J Am Acad Audiol. 2002;13:356-366.
  1. Xu, J., Johnson, J., Cox, R., and Breitbart, D. (2015). Laboratory Comparison of PSAPs and Hearing Aids.  American Auditory Society, Scottsdale, AZ, March, 2015.
  2. Kochkin S. MarkeTrak VIII: 25 year trends in the hearing health market.  Hearing Review. 2009;16(11):12-31.
  3. Kochkin S. MarkeTrak VIII: The key influencing factors in hearing aid purchase intent. Hearing Review. 2012;19(3):12-25.
  4. The Hearing Review.  (1995).  Page 14.
  5. Consumer Electronics Association. (2014).  Personal sound amplification products: a study of consumer attitudes and behavior.  CEA Market Research Report, August, 2014.
  6. Staab W.  (2015).  Independent hearing aid dispenser directions, July 28, 2014. http://hearinghealthmatters.org/waynesworld/dispensing-systems/costco/
  7. HIA News Release: Senators Introduce OTC Legislation, December 6, 2016 at 10:23 AM.  HIS supports efforts to expand hearing aid use but cautions against “do it yourself” approach.

Self-fitting of hearing devices is an inherent feature of OTC or DTC (over-the-counter; direct-to-consumer) hearing aids.  What can we expect now that this is becoming an active feature of hearing aid sales?

The real issue, as expressed by Bess1, is not how an OTC or DTC hearing aid delivery system benefits hearing aid manufacturers and hearing professionals, but will this benefit those with hearing loss?  The OTC option is intended to provide greater access for individuals to use amplification than does the current model of hearing aid distribution.  Without a doubt, the current distribution system would not be able to manage the influx of sales if the intended goal is to substantially increase the number of individuals using amplification.2   With this in mind, some have been concerned that OTC (over-the-counter) sales, which essentially includes self-fitting of hearing aids, cannot be managed effectively by the consumer.


Self-Fitting Defined

What is a self-fitted hearing device?

The essence of self-fitting is that the assembly, fitting and usage of hearing aids is completed by the user without any hearing experts and equipment, other than the hearing aid.

In this series of posts that will follow, as related to OTC sales, PSAPs (Personal Sound Amplification Products) are considered to be the same as OTC hearing aids, which they are, regardless of how some chose to nit-pick definitions.

The definition above of self-fitting is different than what some have suggested, such as:

“A self-contained, self-fitting hearing aid (SFHA) is a device that enables the user to perform both threshold measurements leading to a prescribed hearing aid setting and fine-tuning, without the need for audiological support or access to other equipment.”3

This author prefers the initial definition of self-fitting and has problems with this latter definition, and for other similar definitions that suggest the need for audiometric data for a self-fitted device, for the following reasons:

  • There is no need to have a measurement of one’s hearing thresholds. This has been explained in a previous post.  For the most part, there is little difference in the threshold configuration of most mild and moderate hearing losses, other than the sensitivity level and minor changes in the high-end response, much of which can be managed easily with a user-adjustable volume control, and a couple of push-button response changes, if that is even desired.
  • The FIRST, and PRIMARY decision that all hearing aid users make is if the instrument has sufficient gain. Is it proving enough amplification so that they can hear others/things better than without amplification, and to their satisfaction.  Knowing this, give the customers a user-controlled gain option.  After all, they can make a better decision as to what gain they will accept than can an external evaluator or fitting formula.4,5   As to the significance of frequency response adjustment, few users can tell the difference in frequency response unless it is dramatic – more dramatic than the environmental differences often programmed into hearing aids today.  Anecdotal evidence can easily be obtained by asking customers if they can tell the difference between the various environmental settings.  To most, they sound the same, with the exception of a loudness reduction when the directional microphone performance is chosen (generally, listening in noise).
  • To use hearing thresholds to lead to a prescribed hearing aid setting is no guarantee of a successful hearing aid fitting because of the great variability in target gains projected by different hearing aid formulae.6,7,8,9,10 As reported previously, Hearing instrument manufacturers’ first-fit algorithms are known to deviate significantly from actual prescriptive targets.8,10   Aazh and Moore found that using first-fit, 64% of hearing instruments failed to come within +/- 10 dB of target at one or more frequencies.  Similar results were found for open-fit hearing aids.10
  • Hearing thresholds have little or nothing to do with fine tuning of a listening device. Fine tuning is generally performed by changes to target gains based on subjective responses by the hearing aid user, not on audiometric thresholds.  Adjustments are generally made by using the program’s “Fitting Wizard” (which is a calculated guess), or best, by adjustment using real-ear measurements.  Unfortunately, few audiologists actually use real-ear measurements, even though many have the equipment in their offices.11,12,13,14,15    In a survey of dispensers, 57% reported owning real-ear equipment, but only 34% (considered an inflated percent, and perhaps closer to 25%16) of all respondents who reported that they used the equipment consistently, even though it is considered a major part of Best Practice.13    

The suggestion that a measurement of hearing threshold is required is without doubt, the single greatest artificial/intentional roadblock to self-fitting of hearing aids.   

What is Available for Self-Fitting?

An excellent review of partial self-fitting without audiological support has been published by Keidser and Convery.2  The devices identified in the reviews of that publication universally required access to other hardware, such as a proprietary interface, computer, smartphone, or tablet to enact the fitting.  None of such devices would be considered a “self-contained” or “self-fit” hearing aid by this author because they rely on some additional hardware/interface. 

Because certain approaches employ additional hardware does not make them poor options for self-fitting in and of themselves, but a true self-fit device should be something that any person can use, regardless of where in the world they live.  And, to really meet the unserved market, it should not require an additional device that many customers do not nor will not have access to, or perhaps cannot manage.  What if they have no cell phone service, can’t afford a computer, smart phone, or tablet?  A truly self-fitting device should require nothing more than the product itself, along with easily understood instructions on its use.


Are Any Such Self-Fitting Hearing Aids Available? 

Fortunately, current devices now exist that can be considered fully self-fitting without audiological support, assuming that one ignores the unnecessary “requirement” that an audiogram is necessary.  The Bean by Etymotic Research, the Tweak by Ear Technology, and the CS50+ by Sound World Solutions are such devices, as are essentially most PSAPs.  If any of these devices also connect wirelessly with a smart phone or with providers that offer assistance through a telehealth infrastructure or integration into a traditional hearing health-care model, that is good.  But, it is not a necessary requirement for self-fit because most (not all) of such connections are designed to obtain or use some kind of audiogram, thinking this is necessary because it has been suggested by hearing professionals.  The attempt at obtaining an audiogram is fraught with regulation and calibration issues that are best left to traditional hearing aid fitting, where it is believed that an audiogram is necessary to fit a hearing aid. 

Predicting Hearing Level Without an Audiogram

Can this be done?  It is suspected that most hearing professionals make such a prediction prior to taking an audiogram, by just talking with the customer.  It has been suggested that such a prediction could be made just using a proper questionnaire.

At least one self-assessment questionnaire has been shown to provide valuable information about an individual’s hearing levels without resorting to a pure-tone audiogram.  For example, the following comments were made relative to an inquiry made to the authors of the NSRT test, asking how well their questionnaire items related to measurements of hearing levels by category of loss.  The NSRT test was questioned because it is one of the few that has good statistical data associated with it.  The response was as follows:

“You asked how well the questionnaire items relate to the “final estimate of hearing levels by category”, as well as “general hearing level”.  Simply put, the six Likert items to which respondents provide data entries conspire very nicely to form an independent measure of hearing sensitivity (KR20 = .92).  Simple-sum scores on the questionnaire separate respondents into four HL groups (normal, mild loss, moderate loss, severe loss).  I was quite surprised to see how well respondents separate into categories based upon hearing loss (predicted PTA) simply using the questionnaire data.”17

If the purpose of a self-fit hearing aid is to get individuals who have mild-to-moderate hearing loss, and who take no amplification action because of the various hoops required of them to go through, along with unacceptable/unaffordable costs, it would appear that the drive to action should have as few obstacles as necessary.  And, the big elephant obstacle in the room relates to the audiogram.

Self-fitting of hearing aids will continue in next week’s post.



  1. Bess F. (2004).  Vanderbilt University, Fred Bess Ethics Class, November 28, 2004, Memphis, TN.
  2. Marquardt K, Hosford-Dunn H, Fishback P. (2017).  The supply and demand for audiologists: preliminary modeling and analyses.  http://hearinghealthmatters.org/journalresearchposters/files/2017/06/Supply-and-Demand-for-Audiologists-Preliminary-Modeling-and-Analyses.pdf.
  3. Keidser G. and Convery E. (2016). Self-fitting hearing aids: status quo and future predictions.  Trends in Hearing, Vol. 20, 1-15, April.
  4. Killion M. (2004). Myths about hearing aid benefit and satisfaction. The Hearing Review, August, pp 14, 16, 18-20, 66.
  5. Keidser G, Brew C, Peck A. (2003). Proprietary fitting algorithms compared with one another and with generic formulas.  Hearing Journal. 56(3):28, 32-38.
  6. Hawkins D. and Cook J. (2003). Hearing aid software predictive gain values: how accurate are they?  The Hearing Journal. July, Vol. 56, No 7, pp 26, 28, 32, 34.
  7. Aarts, N., Cafee, C. (2005). Manufacturer predicted and measured REAR values in adult hearing aid fitting: accuracy and clinical usefulness. Int. J. Audiol. 44, 293-301.
  8. Azah H. and Moore BCJ. (2007). The value of routine real ear measurement of the gain of digital hearing aids.  Journal of the American Academy of Audiology, 18(8), 653-664.
  9. Sanders, J., Stoody, T., Weber, J., Mueller, H.G., 2015. Manufacturers’ NALNL2 fittings fail real-ear verification. Rev. 21 (3), 24.
  10. Azah H, Moore BC, & Prasher D. (2012). The accuracy of matching target insertion gains with open-fit hearing aids. American Journal of Audiology, 21:175-180.
  11. Beyer C. (2011). Common mistakes in routine hearing aid fitting.  http://www.audiologyonline.com/ask-the-experts/common-mistakes-in-routine-hearing-39.
  12. Kirkwood D. (2006) Survey: Dispensers fitted more hearing aids in 2005 at higher prices. Hear J 59:40–50.
  13. Bamford, J., Beresford, D., Mencher, G., 2001. Provision and fitting of new technology hearing aids: implications from a survey of some “good practice services” in UK and USA. In: Seewald, R.C., Gravel, J.S. (Eds.), A Sound Foundation through Early Amplification: Proceedings of an International Conference. Phonak AG, Stafa, Switzerland, pp. 213-219.
  14. Mueller HG, Picou EM. (2010). Survey examines popularity of real-ear probe-microphone measures. Hear Jour. 2010;63(5):27-28.
  15. Mueller HG. Probe-mic measures: Hearing aid fitting’s most neglected element. Hear Jour. 2005;57(10): 33-41.
  16. Mueller HG. 20Q: Real-ear probe-microphone measures—30 years of progress? AudiologyOnline, Article 12410 [Jan 2014].
  17. Garrison W. and Bochner J. (2017).  Personal communication in reference to the NTID (National Technical Institute for the Deaf) NSRT Speech Recognition Test.