Waiting for the Third Shoe (of Three) to Drop

Holly Hosford-Dunn
July 5, 2016
Harvey Abrams PhD

Harvey Abrams PhD

“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.


My last post, “Waiting for the Second Shoe (of three) to Drop”, was written just before the most recent IoM report was published. Now that it has, we are waiting for the last of the Hearing Health Industry Trilogy of Reports to appear; i.e., FDA’s response/recommendations/changes in policy, based on the April 21st workshop on “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids” (read, “What are we Going to do About PSAPs?).


The Second Shoe Drops


If you haven’t reviewed the final IoM report,  also referred to as the NAS report (for the National Academies of Science, Engineering and Medicine), I suggest you do. It is a reasonable set of recommendations made by a committee of thoughtful and conscientious individuals.

The committee based its conclusions on a review of the current science and on a series of meetings where stakeholders representing all facets of the hearing universe (academic researchers, industry representatives, professional association spokespersons, audiologists, hearing instrument specialists, government agency representatives, and consumers and their family members) had the opportunity to present their positions on the pressing issues of the day associated with the affordability and accessibility of adult hearing health care in America.


Worthy of Applause


I believe the majority of us could easily support most of the 12 recommendations issued by the committee, such as these examples below:

  • Recommendation 2: Develop and promote measures to assess and improve quality of hearing health care services
  • Recommendation 5: Improve access to hearing health care for undeserved and vulnerable populations
  • Recommendation 6: Promote hearing health care in wellness and medical visits
  • Recommendation 10: Evaluate and implement innovative models of hearing health care to improve access, quality, and affordability
  • Recommendation 11: Improve publicly available information on hearing health

One of the recommendations that many clinicians will applaud is Recommendation 3: “Remove the Food and Drug Administration’s regulation for medical evaluation or waiver.” Clearly, the NAS committee was convinced that, as relatively few adults present with hearing loss that can be corrected medically or surgically and that the audiologic examinations performed prior to hearing aid selection and fitting will reveal pathology in those cases that would warrant a referral for medical evaluation, the FDA regulation was creating an unnecessary burden on the patient resulting in increased cost and decreased accessibility with little benefit in terms of protecting the health of the consumer.


Hold the Applause


Undoubtedly, the most contentious of NAS’ recommendations is Recommendation 7:

“Implement a new Food and Drug Administration category for over-the-counter wearable hearing devices.”

So, now we have both the PCAST and the NAS committee recommending a new category of device for individuals with mild to moderate hearing loss (more about this later) that can be purchased OTC and be exempt from 510(k) premarket review designed to ensure the safety and efficacy of these new devices. Interestingly, the NAS recommendation includes a list of safeguards related to the sale of these new category of devices that include consumer labeling detailing the electroacoustic characteristics of the device and the communication situations and medical conditions where professional consultation is advisable. The NAS further recommends that these OTC devices be subject to specific safety requirements and standards, and be subject to some, but not all, of the quality system regulation (QSR) requirements that are compulsory for hearing aid manufacturing.

I’m confused. If these devices are so safe that they can be sold over-the-counter without professional involvement, why the need for such an extensive list of protections? I thought these devices are the hearing equivalent of OTC eyeglasses (cheaters). I don’t know where you buy your cheaters, but the only warning I saw on the ones I recently purchased at CVS was that I would be prosecuted if I walked out the store without paying for them.


HIA’s Answer to “What Are We Going to Do About PSAPs?”


Now the FDA needs to make a decision about PSAPs. The deadline for submitting comments to the FDA recently passed (June 30th). I had the opportunity to read the Hearing Industries Association (HIA) comments to the FDA which I felt were thoroughly researched, convincingly argued and evidence-based.  In the interest of full disclosure, I am a paid consultant to the HIA although I did not contribute to the comments submitted to FDA.

If you are interested in a thorough understanding of the position of those who oppose the creation of a new classification of OTC device to include a convincing evidence-based repudiation of many of the PCAST recommendations (which HIA appropriately described as “more advocacy than science”), I would urge you to read this well-crafted document.  In order to accept the recommendations of the PCAST and NAS concerning the creation of a new classification of hearing devices, you, necessarily, must accept the following as true:

  • Mild to moderate hearing loss is not a clinically significant problem
  • Ineffective hearing products are harmless
  • The safety of consumers is important enough to classify hearing aids as Class I or II medical devices but the safety of consumers wearing PSAPs is of no concern
  • The hearing aid industry lacks innovation
  • QSRs do not play a critical role in ensuring the safety of patients and the effectiveness of products
  • QSRs adversely affect innovation, cost, and access
  • Unregulated OTC devices would necessarily result in increased utilization and satisfaction
  • Consumers do not already have access to PSAPs
  • Changes in the distribution of hearing aids are having no impact on cost

The HIA document takes on each of these issues head-on with reasoned evidence-based arguments. As an added bonus, when you access HIA’s comments to FDA you will also have access to Exhibit A which is the “Response of Hearing Industries Association to October 2015 PCAST Report” which is also a great read for you hearing policy wonks out there.


Does The Shoe Fit?


One more thing before I go: Who decided we could conflate “mild” and “moderate” hearing losses (the degrees of hearing loss deemed “appropriate” for the PCAST and NAS recommendation concerning a new classification of OTC hearing device)? The assumption that these two categories of hearing loss severity represent the same functional consequences went completely unchallenged in the committee hearings or in any of the comments that I’ve read. How can we accept any policy change that argues that an individual with an average hearing loss of 26 dBHL (the lower fence of mild) faces the same challenges and is managed the same way as an individual with an average hearing loss of 55 dBHL (the upper fence of moderate impairment)?

Where’s my shoe?


This is Part 17 of the Peeling the Onion series.  Click here for Part 1, Part 2,  Part 3,  Part 4,Part 5, Part 6, Part 7, Part 8, Part 9Part 10,Part 11,  Part 12, Part 13, Part 14, Part 15, Part 16.


Harvey Abrams, PhD, is an audiology research consultant in the hearing aid industry. Dr. Abrams has served in various clinical, research, and administrative capacities in the industry, the Department of Veterans Affairs and the Department of Defense. Dr. Abrams received his master’s and doctoral degrees from the University of Florida. His research has focused on treatment efficacy and improved quality of life associated with audiologic intervention. He has authored and co-authored several recent papers and book chapters and frequently lectures on post-fitting audiologic rehabilitation, outcome measures, health-related quality of life, and evidence-based audiologic practice.  Dr. Abrams can be reached at [email protected]

feature image by Ross Land/Getty

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