Independent scientific research and unbiased, transparent opinion plays a critical role in any credible profession. It is the application of the scientific method in the problem-solving process and the endless striving to understand the truth, that separates, say, the practice of modern medicine from alchemy. At the same time, it is easy to find recent examples of scientists with undisclosed political or industry connections who mislead the public (and even their fellow colleagues) by cherry-picking studies that tacitly support the benefactors of their scientifically dubious ideas and opinions. Look no further than the tobacco or fossil fuel industries to find examples of how a few researchers were able to plant the seed of doubt around a growing scientific consensus that unabashedly conflicted with the motives of large corporate interests (for more details see Merchants of Doubt).
On August 14, a working group made up of selected individuals from the four professional associations (AAA, ADA, ASHA and IHS), working for approximately 10 months, published a Consensus Statement, titled Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness.
According to a press release the purpose of their Consensus Statement was to identify a careful balance between issues of consumer access and affordability while ensuring safety and effectiveness in all hearing aid devices. On the same day OTC Consensus Statement was made public, it received a fulsome endorsement from the Hearing Industries Association, the trade association of hearing aid manufacturers and other related products . The entire OTC Consensus Statement from the Working Group can be found here.
On the surface, the Consensus Statement appears to be a thoughtful, scientifically valid document. It cites peer reviewed studies to support many of their claims. However, a more careful reading of the OTC Consensus Statement by an objective clinician – even with minimal training on the application of the evidence-based practice methods – suggests the consensus statement may contain several inaccuracies and what some might label as half-truths.
First, the authors of the Consensus Statement are unnamed. Without proper transparency and disclosures, both the public and the profession cannot know about any potential conflicts of interests related to the drafting of the statement. It is safe to assume, however, after carefully reading the document some of the authors are conflicted. That is, it is likely some of the authors or reviewers of the statement represent industry and therefore have a vested interest in restricting the acoustic parameters and labeling of hearing aids sold over-the-counter.
Clinicians Ought to be Skeptical
Audiologists who abide evidence-based decision making might have concerns about many of the recommendations in the Consensus Statement.
A couple of examples to illustrate this point:
- The authors define a mild to moderate hearing loss as one with no pure tone thresholds worse than 55 dB HL. Most clinicians know this is not standard practice (use of pure tone averages, calculated at some combination of .5, 1, 2, 3 or 4KHz is standard practice) and it severely restricts the classification of moderate hearing losses.
- The authors cite one study to make the case that maximum output should be limited to 110 dB SPL in OTC devices, and ignore several other peer reviewed studies that suggest a 120 dB SPL output in OTC devices is likely safe and effective.
To many independent experts, some of which were willing to go on the record with their comments, the Consensus Statement appears to be largely a charade, intended to support the interests of hearing aid manufacturers more than solve the problem of access and affordability of hearing care through safe and effective evidence-based regulation of OTC devices.
Three independent experts and opinion leaders offered their views on the matter.
Based on the statements below, the Working Group may have arrived at a consensus within their small assembly but, looking more broadly to independent researchers and thought leaders, the Working Group’s consensus appears to some as more of a rubber stamp to support the interests of the industry.
Responses to the Consensus Statement from Hearing Care Associations on Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness
Richard Einhorn, Einhorn Consulting, LLC, New York, NY
When preparing their Consensus Paper of regulatory recommendations to the FDA regarding OTC hearing aids, the Hearing Care Associations clearly assumed that over-the-counter hearing aids will (1) look and function like traditional hearing aids and (2) be used the way hearing aids are currently being used. In my opinion, neither assumption is warranted. As a result, their paper urges restrictions on OTC hearing aids and their marketing that could stifle innovation and cause confusion.
Because people with mild or moderate situational hearing problems do not necessarily need all-day hearing loss assistance the way those of us with more severe hearing problems do, customers may likely purchase OTC hearing aids primarily for their “consumer” functions such as Bluetooth connectivity for phone calls and high-quality audio streaming. Only in specific situations would users switch on more typical hearing aid functionality. In short, some OTC hearing aids may more closely resemble consumer earphone products both in form factor and feature set than traditional hearing aids.
By assuming that OTC hearing aids will resemble traditional aids, the Consensus Paper recommends that all OTC hearing aids be required to provide “instant-fit eartips.” But eartips serve no useful purpose if OTC hearing aids take a form similar to existing consumer products such as over-the-ear Bluetooth headphones. Likewise, the Paper’s cumbersome marketing recommendation (“Self-Fit Over-the-Counter Hearing Devices”) has the potential to befuddle potential purchasers rather than inform them of what these devices really are: hearing aids sold over the counter.
All of us seek to increase the use of hearing loss compensation technology by people who need it. Of course, OTC hearing aids (like every other product) should be safe and work well. But the Consensus paper should also have taken into account the potential for design innovation that OTC hearing aids, innovation that could help de-stigmatize hearing assistance and make it normative. New types of hearing aids could lead those who need it to use hearing assistance, use it earlier, and — if their hearing problems become more serious — seek out hearing healthcare providers sooner.
Shari Eberts, Hearing Health Advocate, Writer, Speaker and Founder of LivingWithHearingLoss.com
As a person with mild to moderate hearing loss, I am very excited for the launch of OTC hearing aids for several reasons:
- Increased product functionality and innovation,
- Wider and earlier usage by people with hearing loss, and
- Reduced stigma surrounding hearing technology.
The recent Hearing Care Associations Consensus Paper does not speak to these reasons. I am concerned that their recommendations may stifle innovation by strictly defining the form and function that the new OTC hearing aid category will take. I believe strongly that these new devices need to be safe, easy to use and appropriately labeled, but they should also be flexible, innovative and modern.
Let’s not limit progress, but instead embrace increased access and functionality. This may require a new paradigm for the devices themselves as well as for the hearing care industry. I am eager to see where the future can lead.
Wayne J. Staab, PhD, Dr. Wayne J. Staab & Associates, Dammeron Valley, UT
August, 2018, a Consensus Paper from hearing care associations was published relative to “Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness.”1 The organizations involved in writing this Consensus Paper consisted of the AAA (American Academy of Audiology), ASHA (American Speech, Language, Hearing Association), IHS (International Hearing Society), and ADA (Academy of Doctors of Audiology), groups that could be financially negatively impacted by OTC hearing aid sales, depending on how extensively the FDA defines safety and efficacy of such devices. This Paper appears to be endorsed by the HIA (Hearing Industries Association), a trade association representing the major hearing aid manufacturers, who sell their products to hearing aid sellers of these organizations.
The Consensus Paper is intended to influence the FDA in its description of safety and efficacy of the 2017 OTC Hearing Aid Act.2 In what appears to be more than tacit support, the HIA trade association believes that it is “heartening to have the dispensing community finally coalesce around the key issues for consumers relative to OTC”, and that this “unity will positively impact FDA actions on this new category, here’s hoping!”3
To an outsider, this Consensus Paper appears to be a well-thought-out document related to the safety and efficacy of hearing aids, something that the FDA is bound to as a part of the 2017 OTC Hearing Aid Act. The Consensus Paper states in its Forward that “while the goal of making hearing health care solutions more accessible (they somehow left out “affordable”) is agreeable, the FDA needs to provide reasonable reassurance that safety and efficacy will be maintained.” An interesting omission in this statement is that the OTC Hearing Aid Act of 2017 has as two of its primary goals the accessibility and affordability issues. The Consensus Paper has hyped the safety and efficacy while totally ignoring accessibility and affordability. As such, its subtitle: “How to Regulate OTC Hearing Aids for Safety and Effectiveness” describes the primary purpose of the Paper (emphasis added).
- Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness. Consensus Paper From Hearing Care Associations. (August 2018).
- Over the Counter Hearing Aid Act, included in the Food and Drug Administration Reauthorization Act of 2017.
- E-Mail comment from HIA to HHTM, August 18, 2018.
**For Dr. Staab’s entire statement, please see his post: The OTC Hearing Aid Consensus Statement: An Opposing View
How Reliable is the Consensus Statement?
While it is unquestionably true audiologists and hearing aid dispensers cannot fulfill their mission of delivering comprehensive care to individuals with hearing loss without devices supplied by hearing aid manufacturers, it is essential to this mission there be a clear boundary between clinical work and industry. When this boundary is breached, and entanglements between industry and professional organizations are not properly disclosed, both the public and the profession are poorly served.
Given the opinions of the three experts cited above, the biases of the Working Group – either naively or deliberately – influenced a Consensus Statement that arguably only serves to restrict the performance specifications and labeling requirements of hearing devices sold over-the-counter.
Without proper disclosures of the anonymous authors of the Consensus Statement, the public, as well as clinicians, academics and others interested in improving access and affordability of hearing care do not have the ability to properly evaluate the quality of the thought process used to create this statement.
In the end, it would appear, everyone with a vested interest in improving the lives of people with hearing loss are ill-served by this OTC Consensus Statement.
HHTM welcomes and encourages comments and invites others to weigh-in on this important issue.