On July 12th, 2017 the U.S. House of Representatives passed the FDA Reauthorization Act of 2017, which includes the Over-the-Counter Hearing Aid Act, and allows for hearing aid OTC sales.1   

The Act creates a new class of over-the-counter hearing aids and allows non-prescription hearing devices to be marketed to treat mild-to-moderate hearing loss.  This bill is incorporated into the larger FDA Medical Device User Fee Amendments (MDUFA) Act of 2017.  This is in line with Senate Bill (SB-9), yet to be passed, but is expected to be, and signed into law by the President.2 

Over-the-counter hearing devices are intended to be affordable, readily available, and much more in line with what American consumers are willing to spend to improve their hearing.

Self-fitting of Hearing Aids Implies Self-diagnosis

Is self-diagnosis of hearing loss a problem?  Not really, because the vast majority of individuals self-diagnose the fact that they have a hearing loss.  It is for this reason that they seek amplification assistance.  Surveys have shown that the major reason adult consumers look toward amplification is because they notice that their hearing has become poorer.3   It is not because someone tested their hearing and then told them that they had a loss.  An audiogram confirms what they already know.  It primarily puts numbers to their hearing levels, numbers in dB (decibels) that are meaningless to most.  The use of an audiogram to fit hearing aids successfully has come under serious scrutiny.  It has been shown that meeting a prescriptive target does not guarantee hearing aid success, nor that it is even a good starting point.4,5,6,7,8

Are Consumers Able to Self-Fit Their Hearing Loss?

Does knowing that one has a hearing loss also mean that they can then self-fit their loss?  Laboratory studies of self-fitting hearing aids show that even rudimentary self-fitting systems are successful.9,10,11,12   For example, a smart phone app fitting, starting without an audiogram, showed that 72% of research participants found such a fitting system equivalent or better than settings provided with a prescriptive fitting method based on pure-tone audiometric thresholds.13   During the late 1960s, 1970s, and early 1980s, essentially every hearing aid manufacturer offered a Master Hearing Aid that allowed the consumer to select their own amplification level (gain), along with selecting a response from pre-set options – all performed without an audiogram.  Literally hundreds of thousands of hearing aids were fitted successfully using such systems.  In essence, these were self-fit hearing aids because it was consumers who were making the determination as to what functioned best for them.  This procedure was subsequently replaced with hearing aid fitting formulae based on pure-tone thresholds, but as was pointed out above, and previously, such prescriptive formulae have not been shown to be reliable.14   

Where Does the Consumer Start?

Figure 1. The average judged value for all the hearing aid devices, regardless of the purchase price, was about 60, regardless of the advanced features. (Calculated by Killion from Van Vliet, 2002 data and replotted here).

There is no question that the first adjustment decision a hearing aid user makes relates to the overall loudness – a decision they can make better than can a third party.  The most common type of hearing loss results in a person having trouble hearing soft sounds.  It is for this reason that the hearing aid (an amplifier) is used.  What is concerning is that although hearing aid technology has advanced greatly in the past years, a review of studies shows that the user satisfaction has remained essentially the same (Figure 1).  The primary technology features for hearing aids (digital signal processing, directional microphones, feedback suppression systems, noise reduction, and compression) can be, and have been available in many of the products that will qualify as low-priced/affordable OTC hearing aids.

Effective Self-Fitting of Hearing Amplification Is a Reality

Is a consumer able to self-fit their hearing loss effectively?  In addition to the rudimentary self-fitting approaches referenced earlier in this post, and knowing the history of hearing aid fittings using Master Hearing Aids, self-fitting appears to be somewhat of a “normal” process.  The consumer makes the decisions as to what sounds appropriate to them.  Additionally, current technology at the user’s disposal tends to support this.

“Other market experiments showing the ability to effectively self-fit are proceeding in the form of smartphone apps that use the microphone and signal-processing power of the phone itself. Smartphone apps can function as self-fitted hearing aids when combined with consumer-grade earphones. One recent investigation showed that, when compared with conventional hearing aids that had been fit to research participants according to state-of-the-art professional fitting, the two smartphone apps yielded equivalent speech understanding in noise, higher user-perceived benefit, and better satisfaction in terms of adjustability (Amlani et al., 2013). This is convincing evidence that users can easily learn to manipulate an effective user interface to achieve benefit as good as that achievable with a conventionally-fit hearing aid. Self-fitting may even yield superior outcomes if the user can continually revise the fitting as he/she grows accustomed to amplification, and in different settings.”16

Up until the current legislation that will allow OTC sales of hearing aids, they were not allowed to be purchased over-the-counter.  Instead, people had to have a professional evaluate their hearing loss, set the hearing aid’s sensitivity and teach proper use.

However, in a landmark study, Indiana University researchers indicate hearing aids fitted by a patient are just as effective as those fitted by a professional audiologist using best practice procedures.17   The OTC model studied, when compared with a placebo and audiologist best practice model, yielded only slightly poorer outcomes than the audiology best practice model, but suggested that efficacious OTC models may increase accessibility and affordability of hearing aids for millions of older adults.   Study author and IU professor Larry Humes says:

“…that could have important implications for making hearing aids more accessible to the millions of people who need them but don’t have the money to buy them. He adds the current “best practices” model keeps millions of people from receiving the hearing tools they need.”

The study, supported by NIDCD (National Institute on Deafness and Other Communicative Disorders – NIH) summarized the findings stating that an OTC hearing aid delivery model for older adults with mild-to-moderate hearing loss reported a similar level of benefit as participants who purchased the same hearing aids through an audiologist following best practices.18

More studies are needed to assess the generalization of the results to other patient populations, other devices, and other models of OTC service delivery, according to Humes.  Still, the results are impressive and confirm that consumers can make self-fitting decisions that function well for them.

Additional studies at the NAL (National Acoustic Laboratories in Australia have also shown that consumers are able to self-fit hearing aids.  Convery et. al. sought to determine if hearing-impaired adults in the developing world could independently and accurately assemble a pair of hearing aids by following instructions that were written and illustrated according to best-practice health literacy principles.  They found that individuals of diverse backgrounds can manage the self-fitting hearing-aid assembly task as long as health literacy levels and cultural differences are considered,19,20   The authors commented further that a self-fitting hearing aid, designed to be assembled and programmed without audiological or computer support, could bring amplification to millions of people in developing countries, who remain unaided due to the lack of a local, professional, audiological infrastructure.  The two blue-shaded comments to the right summarize their preliminary recommendations on self-fitting hearing aids in which they showed at last one (tested just one) currently available self-fitting product was comparable to those measured with professionally dispensed hearing aids.21

With the establishment of an OTC category, it is logical to expect considerable innovation in self-fitting and adjustment methods without the need for an audiogram.

Consumer Product or Medical Device?

Successful and massive use of smart phone apps; PSAPs, OTC, Internet and mail-order sales; general consumer amplification devices (iPods™, MP3 devices, amplified earphones, etc.); amplified telephones; TV and radio volume controls; etc. confirm that amplification for a person having difficulty hearing is not identified with a medical problem, but instead is much more closely identified to consumer products.  All definitions to the contrary do not change this reality. 

In the face of OTC hearing aid sales, the FDA Guidance for PSAPs should be eliminatedIt no longer makes any sense and contributes only to confusion.



  1. S. House of Representatives. H.R. 2430 – FDA Reauthorization Act of 2017.  July 13, 2017
  2. S. Senate. S9 – Over-the-Counter Hearing Aid Act of 2017.  https://www.warren.senate.gov/files/documents/3_21_17_Hearing_Aids_Bill_Text.pdf.
  3. Kochkin S. (2002).  MarkeTrak VI: Hearing Aid Industry Market Tracking Survey 1984-2000.  Knowles Electronics, Inc.  
  4. 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.
  5. Aarts, N., Cafee, C. (2005). Manufacturer predicted and measured REAR values in adult hearing aid fitting: accuracy and clinical usefulness. J. Audiol. 44, 293-301.
  6. 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.
  7. Sanders, J., Stoody, T., Weber, J., Mueller, H.G., 2015. Manufacturers’ NALNL2 fittings fail real-ear verification. Rev. 21 (3), 24.
  8. 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.
  9. Elberling, C, & K Vejby Hansen (1999): Hearing instruments: Interaction with user preference. In Auditory Models and Non-Linear Hearing Instruments, Proc 18th Danavox Symposium (eds. AN Rasmussen, PA Osterhammel, T Andersen, & T Poulsen), 341-347.
  10. Moore, BC, J Marriage, J Alcantara, & BR Glasberg (2005): Comparison of two adaptive procedures for fitting a multi-channel compression hearing aid. Int J Audiol, 44(6): 345-357.
  11. Dreschler, WA, G Keidser, E Convery, & H Dillon (2008): Client-based adjustments of hearing aid gain: The effect of different control configurations. Ear & Hearing, 29(2): 214-227.
  12. Zakis, JA, H Dillon, & HJ McDermott (2007): The design and evaluation of a hearing aid with trainable amplification parameters. Ear & Hear, 28(6): 812-830.
  13. Van Tasell D, Sabin A, Franck K. (2014). User self-adjustment of a simulated hearing aid using a mobile device. Int Hearing Aid Research Conference, Lake Tahoe, CA, August.
  14. Staab W, with Chasin M, Christensen L, Beck D, and Staples C. (2015).  Rants!  Some things we would change – if we could.  Hearing Review, Vol. 30, pp 14-17.
  15. Comments of Bose Corporation. (2016). Van Tasell D. and Rabinowitz W.  Via Electronic Submission, to Division of Dockets Management (HFA-305) Food and Drug Administration, Docket No. FDA-2013-D-1295-0048, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Draft Guidance for Industry and Drug Administration Staff: Reopening of the Comment Period.
  16. Amlani, AM, Taylor B, Levy C, & Robbins R. (2013). Utility of smartphone-based hearing aid applications as a substitute to traditional hearing aids. Hearing Review, Dec: 17-22.
  17. Humes L, Rogers S, Quigley T, Main A, Kinney D, and Herring C. (2017).  The effects of service-delivery model and purchase price on hearing-aid outcomes in older adults: a randomized double-blind placebo-controlled clinical trial.  American Journal of Audiology, Vol. 26, 53-79.
  18. National Institute on Deafness and Other Communication Disorders (NIDCD). U.S. Department of Health & Human Services, National Institutes of Health (NIH). Model approach for over-the-counter hearing aids suggests verifiers similar to full-service purchase. March 2, 2017.  Referring to Humes research funded by NIDCD).  utm_source=NIDCDOther&utm_medium=referral&utm_term=GeneralPublic&utm_content=English&u tm_campaign=HumesHearingAids17)
  19. Convery E, Keidser G, Caposecco A, Swanepoel de W, Wong LL, Shen E. (2013).  Hearing-aid assembly management among adults from culturally and linguistically diverse backgrounds: toward the feasibility of self-fitting hearing aids.  Int J Audiol. 2013 Jun;52(6):385-93. doi: 10.3109/14992027.2013.773407. Epub 2013 Mar 11.
  20. Convery E, Keidser G, Hartley L, Caposecco A, Hickson L, Meyer C. (2011). Management of hearing aid assembly by urban-dwelling hearing-impaired adults in a developed country: implications for a self-fitting hearing aid. Trends Amplif. 2011 Dec;15(4):196-208. doi: 10.1177/1084713811431694. Epub 2011 Dec 26.
  21. Keidser G and Convery E. (2016).  Preliminary observations of self-fitted hearing aid outcomes. The Hearing Journal, Nov. 2016 pp 35-38.

Matthew Bromwich, M.D.  
Pediatric Otolaryngologist – Head and Neck Surgeon

by Matthew Bromwich, M.D.*

Outreach work comes with many challenges, not the least of which is transportation of medical equipment. As an ENT surgeon, I travel with a portable audiometer. Typically, this device is a donated, tabletop, wired suitcase device with a handle. We have traveled to remote communities up north and to our outreach work in east Africa using these types of devices. Tablet audiometry helps overcome some of these challenges.


Inconsistent Access to Care

Another challenge is that these remote areas also suffer from inconsistent access to care as specialists may only visit a few times a year. It is not unusual for patients to have been waiting for weeks, months, or even years to be seen by a specialist. Northern Canadians, for example, are also at risk of travel cancellations due to severe weather that may result in missed appointments and further significant delays.  These periodic, punctuated outreach trips make it difficult for us to provide the best health care. Without specialist visits, patients may be required to travel great distances at great expense to receive care.


Leave Behind What You Take and Use

Over the years, we have found that leaving behind the equipment that we carry with us on these trips can be an effective approach. In addition, by training local health care providers, they may be able to continue the work after we leave. This is only practical if the system is inexpensive – meaning that it can easily be replaced if it gets damaged or stolen – is easily portable (so that it can be moved around to different remote communities), and is simple enough to use that while we are visiting we can train local staff on how to use the medical technology. These local technologists take the form of outreach workers, teachers, nurses, or community family doctors1.  Having local technicians carry on the work we started can help to ensure continuity of care, build sustainable healthcare capacity, and provide an opportunity for those who missed us to be evaluated.  We have found that tablet audiometers perform well in these situations where remote hearing healthcare is required. 

This process is currently in place in several remote communities to provide support to existing audiological services. Currently, we travel only four times a year to Iqaluit to provide access to ENT surgical services. Beginning in January of this year, a pediatrician there started to provide some ancillary hearing testing services to help the only audiologist in the region. He also travels to more remote communities and sees people where they reside thus providing better access.

We have secure online access to all the information that we need to ‘intelligently triage’ these remotely-assessed patients. We can then analyze the test results and use this information to determine who should visit us at the tertiary care hospital for follow-up treatment. Given the very high cost of travel from Iqaluit, this process ensures that we only transport those patients in need, thus saving cost to the entire system, which can then be applied to care for other patients.

We have been expanding this type of remote audiometry program to other outreach clinics, including tuberculosis treatment programs, in more than 12 countries. In these situations, we can monitor patients’ hearing for ototoxic side effects in-situ rather than making them travel to audiology clinics for testing. Notably, a good number of the countries where tuberculosis monitoring is occurring did not have access to audiological services within their borders prior to mobile audiometry. 

To support further expansion, we developed on-line training modules to help technicians better understand both the physiology of hearing and the technical aspects of the equipment2.


Audiology Services Shortages

At the end of the day, we still have an 80% shortage in audiological services, even in North America3,4.  In May 2017, Johns Hopkins published a paper stating that by 2060, the number of adults with hearing loss is expected to double5.  We simply don’t have the capacity to deal with the high incidence of hearing-related problems in urban or rural areas.  One solution is to enable primary care, nurses, and outreach workers to provide more advanced testing by delivering technology that is simple, and accessible so that they can see the patients where they live.  Treating disease early and in the community will help to effectively use our health care dollars and better serve patients’ needs.


*Dr. Matthew Bromwich is an Associate Professor at the University of Ottawa in the Department of Otolaryngology and has been a pediatric surgeon at the Children’s Hospital of Eastern Ontario since July 2009. He completed his medical training at Queen’s University, followed by a surgical residency at the London Health Sciences Centre and a Fellowship at the Cincinnati Children’s Hospital Medical Centre in pediatric airway reconstruction. He has published 25 papers and four book chapters on Otolaryngology.  Dr. Bromwich is the inventor of several medical devices and holds 4 patents on various products in Canada and the U.S. Other research endeavors include treatments for dizziness, mobile hearing testing, video endoscopy and surgical airway reconstruction.  His research aims to democratize access to medical care by delivering innovative and inexpensive solutions.

Disclosure: Dr. Bromwich is the Founder and Chief Medical Officer of Clearwater Clinical. Clearwater Clinical is a company which designs and develops novel medical devices to better serve and treat patients, including a tablet based audiometer called “Shoebox.”


Literature Cited

  1. Rourke R, Kong D, Bromwich M. Tablet Audiometry in Canadas North: A Portable and Efficient Method for Hearing Screening. Otolaryngol — Head Neck Surg. 2016. doi:10.1177/0194599816644407.
  2. Bromwich M, Rocker A, Lefrancois R. Audiometry Essentials – Audiometry Essentials. 2017. http://www.audiometryessentials.com/. Accessed May 27, 2017.
  3. Windmill IM, Freeman BA. Demand for audiology services: 30-yr projections and impact on academic programs. J Am Acad Audiol. 2013;24(5):407-416. doi:10.3766/jaaa.24.5.7.
  4. Freeman B. The Coming Crisis in Audiology. Audiol Today. 2009;21(6):46-53. http://acaeaccred.org/ComingCrisis21.6.pdf.
  5. Goman AM, Reed NS, Lin FR, CL T, WJ M. Addressing Estimated Hearing Loss in Adults in 2060. JAMA Otolaryngol Neck Surg. 2017;31(6):725-734. doi:10.1001/jamaoto.2016.4642.