by Harvey Abrams, PhD.
“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.
Disclaimer: I am a paid consultant to the Hearing Industries Association (HIA) and contributed to the post-workshop filing submitted to the FTC on behalf of HIA which I review in this article. However, the opinions expressed here are entirely mine and do not necessarily represent those of HIA.
Assumptions that Concern
In my last post I commented on my observations while attending the Federal Trade Commission (FTC) Workshop held in Washington DC on April 18th. Specifically, I expressed my concern regarding the apparent preference for assumptions and anecdotal remarks, at the expense of data, voiced by some of the presenters in support of the creation of a separate classification of hearing aids that could be sold over-the-counter (OTC) without professional intervention. I listed the following examples:
- Cost is the key reason that people with hearing loss do not have hearing aids.
- “Information costs” are unusually high, and consumer doesn’t have opportunity to try hearing aids or specific features.
- Competition does not exist at any level – more choices and “better access” will drive down prices.
- PSAPs and hearing aids are the same; the only difference is regulatory.
- PSAPs are safe and effective.
- The current FDA standards apply to just 6 companies.
- Eyeglass/contact lens industry is an appropriate model for hearing aids.
- Many websites are set up by manufacturers to trick consumers.
I did not provide any specific evidence to refute those comments as part of my last article so I will do that here by summarizing HIA’s post-workshop response to the FTC, which addresses each of the assumptions listed above. I strongly encourage the reader to access and read the complete HIA filing for a more comprehensive review of these issues to include specific citations in support of each position discussed below.
Cost is the key reason that people with hearing loss do not have hearing aids
Cost is certainly a reason that some people do not acquire hearing aids. However, objective research and market analysis have shown that cost is not necessarily the primary driver.
For many individuals with hearing loss, the major barrier to purchasing hearing aids is perceived need, a finding supported by both Consumer Reports and MarkeTrak data. Similarly, a 2014 study released by the Consumer Technology Association (CTA) showed that the most common reason for consumers with “a little trouble hearing” not to take action was not cost, but a perception that their hearing difficulties were not bad enough.
“Information costs” are unusually high, and the consumer doesn’t have opportunity to try hearing aids or specific features
Information sources are plentiful, varied and free. In addition to commercial sites, one can easily find information from impartial sources such as the American Academy of Audiology (AAA), American Speech-Language Hearing Association (ASHA), Academy of Doctors of Audiology (ADA), Better Hearing Institute (BHI), Hearing Loss Association of America (HLAA), International Hearing Society (IHS), Consumer Reports, Food and Drug Administration (FDA) and the FTC to name but a few.
In terms of opportunities to try hearing aids or specific features, more than 30 states have adopted laws that mandate trial periods of 30 days or more, and many retailers allow consumers to “try before they buy.” Costco, for example, has a national policy of a 180-day trial period. Manufacturers offer return-for-credit policies of at least 30 days.
Competition does not exist at any level – more choices and “better access” will drive down prices
At the retail level, consumers may purchase hearing aids from many sources including online retailers, speech and hearing clinics, hospitals, manufacturer-owned hearing aid centers, ENT offices, Costco, Sam’s Club, audiology offices, hearing instrument specialist offices, and not-for-profit organizations. CVS has just opened seven hearing centers within stores in the Baltimore-Washington area, with plans to expand to 50 locations by the end of 2017.
The U.S. Bureau of Labor Statistics reported that 6,221 retail businesses sell hearing aids in the U.S. as of July 2014. On the manufacturing side, there is robust competition across the industry. Critics imply that the largest six manufacturers control the market to the exclusion of other manufacturers. However, according to the Department of Justice and the FTC’s own economic measures of market share concentration, six manufacturers is an “unconcentrated” market with a healthy level of competition. At last count, there were 97 entities in FDA’s registered manufacturer database listed as manufacturers of hearing aids.
PSAPs and hearing aids are the same; the only difference is regulatory
PSAP manufacturers have not presented convincing clinical evidence indicating that their products perform at least as effectively as hearing aids across the hearing loss spectrum. Furthermore, to the extent that PSAP electroacoustic analyses have been performed and published, such data do not demonstrate how well these devices will address hearing loss when used by a consumer to self-diagnose and self-treat.
PSAPs are safe and effective
The long-term effects and safety-related performance of PSAP devices are unknown. The literature on PSAP safety and efficacy in clinical use is meager, at best. Studies have shown that some PSAPs are potentially unsafe due to their high output levels. Even with the adoption of the current CTA voluntary standard, PSAP manufacturers can choose not to comply and may continue to market and sell these devices regardless of their safety or efficacy.
The current FDA standards apply to just six companies
While six manufacturers hold the majority of market share, there are 97 companies registered as hearing aid manufacturers with FDA. FDA’s regulatory authority extends to all 97 manufacturers and would apply to any other future hearing aid manufacturers.
Eyeglass/contact lens industry is an appropriate model for hearing aids
I doubt that the readers of HHTM need to be convinced that this is an absurd statement. It ignores the fact that vision and hearing (and vision loss and hearing loss) are different physiological and pathophysiological processes. The appropriate visual analog for presbycusis is macular degeneration, not presbyopia. I can’t imagine PCAST, FDA, or FTC supporting a recommendation that individuals with macular degeneration manage their visual difficulties with OTC readers.
Many websites are set up by manufacturers to trick consumers
One of the presenters at the FTC workshop told of her experience on WebMD, which reportedly redirected her to a manufacturer website after failing a hearing screening. I searched and could find no such hearing screening test on WebMD. What I did see was a clearly marked advertising banner for one of the manufactures at the top of the WebMD page. Clicking on the banner took me out of WebMD and into the manufacturer’s website where I had the opportunity to take an online hearing test.
Furthermore, six of the top seven Google hits for “online hearing test” unambiguously identify the manufacturer or distributor offering the test. The seventh site is not affiliated with any manufacturer. These practices could hardly be described as “trickery;” on the contrary, the process for the consumer could not be any more transparent.
I am not naïve; quite the contrary. I’m perfectly aware that what I write here in opposition to, what I consider, a “rush to legislation and regulation” will not have any impact on what currently appears to be an inevitable outcome to this issue.
I do believe, however, that it’s important that we create and preserve a written record which questions the misleading comments and unsupported assumptions that have characterized this OTC debate from the beginning.
Callaway S, Punch J. An electroacoustic analysis of over-the-counter hearing aids. Am J Audiol. 2008;17:14-24.
Federal Trade Commission. Now Hear This: Competition, innovation, and consumer protection issues in hearing health care. April 18, 2017.
Rønne, F., Rossing, R. (2016). Are Hearing Aids the Better Rehabilitative Choice When Compared to PSAPs? Hearing Review, 23(11):26-29
Harvey Abrams, PhD, is a consulting research audiologist 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 email@example.com
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