Please, No More Shoes!

Holly Hosford-Dunn
January 31, 2017

by Harvey Abrams, PhD.

Harvey Abrams PhD

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

As we all know by now, the third shoe (or was it a boot) dropped with a loud thud heard ’round the industry. The FDA appears to be investigating the feasibility of creating a new category of basic hearing aids that adults can purchase as an over-the-counter (OTC) device without medical clearance, prescription, or an evaluation by licensed professionals.


Consensus and Predicament


The PCAST supports this; the NAS supports this; HLAA, the leading consumer group for people with hearing loss, supports this; 2 Senators from opposing political parties support this, and even the former President of the United States supported this (and there’s no reason to believe that our current President will not support it as well). In an era of bitter bipartisanship, isn’t it interesting (and not a bit ironic) that the one issue that seems to bring everyone together in this great Kumbaya moment is the high cost of hearing aids!  

It’s not my intention to relitigate the flawed assumptions that, in particular, formed the basis of the PCAST report, nor review how we got ourselves into this predicament but, rather, I’d like to discuss some of the issues that will likely impact the pace and scope of implementation of a change in FDA regulations and, more importantly, how we can take advantage of these developments.


OTC Issues


It is important to remember that the creation of an OTC class of devices is not a fait accompli. In its press release announcing the suspension of its medical examination/waiver requirement, the FDA references the OTC issue as follows:

The FDA intends to consider and address PCAST and NAS recommendations regarding a regulatory framework for over-the-counter hearing aids without the requirement for consultation with a credentialed dispenser. The agency is committed to seeking additional public input before proposing such an approach.

The release reminds the public that, The FDA … protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The bill introduced in the last Congress, The Warren-Grassley Bill (S9) (which needs to be reintroduced in the 115th Congress) also addresses the issue of safety: the legislation requires FDA to include requirements that provide reasonable assurances of the safety and efficacy of OTC hearing aids, describe the requirements under which the sale of OTC hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, and  determine whether OTC hearing aids require a report under section 510(k) to provide reasonable assurance of safety and effectiveness.


Steps in the Process


Several important things must happen before we see a new category of hearing aids (note that OTC products are already abundantly available).  

  • The legislation must be passed by both houses of congress and signed into law by the President;
  • The FDA must promulgate and publish an initial draft of the new rules which comply with intent of the legislation with specific attention paid to the issues of safety;
  • The FDA must allow a period of comment which is typically 90 to 180 days following which the FDA must, by law, read and analyze all of the major comments, and then issue a final rule;
  • The final rule will need to go through an internal review process before being issued.


A State-Side Stumbling Block


And here is another interesting provision of the proposed legislation that may create some heartburn, particularly among states-rights advocates. The language of the bill specifically prohibits the states from establishing or continuing in effect “any law, regulation, order, or other requirement related to the manufacturing, marketing, sale, customer support, or distribution of over-the-counter hearing aids.”

In effect, the legislation would strip consumers of state-mandated protections, such as refunds, leaving the consumer in a “caveat emptor” position and the states powerless to do anything about it. One could argue that the consumer is still protected by other existing state consumer rights laws but don’t forget, these OTC products will be regulated by the FDA – they continue to be medical, not consumer, devices.


A Call for Evidence-Based Policy Decisions


From a personal perspective, I do not object to OTC products. I believe they can represent, for the right individual, an important and potentially effective solution to their hearing problem–a solution, in fact, that should be part of every clinician’s tool box in addition to PSAPS, hearables, wearables, brain fitness training software, assistive technology, group AR sessions, and every other technological and non-technological strategy that has been shown to effectively improve the communication function and quality of life of individuals with hearing loss.

I have no doubt that we will see improvements in OTC technology and the methods associated with self-fitting them. What objections I do have is directed toward the current rush to legislation and regulation in an environment characterized by misinformation and false assumptions voiced by our nation’s senior scientific and technology experts (e.g. OTC hearing aids and OTC eyeglasses are equivalent; mild and moderate hearing loss can be managed identically; there has been no innovation in the hearing aid industry; there is little value associated with the professional component to hearing health care, etc., etc., etc.).

 Just as we demand evidence-based practice in the clinic, we should demand evidence-based decision making by our regulators and legislators. Unfortunately, what we are currently witnessing in this rush to create a separate category of OTC hearing aids is not based on any existing body of evidence.

After a very busy year of hearings, committee meetings, reports, and press releases we have some time to catch our breath before we see a change in the FDA rules pertaining to OTC devices, particularly given the slow pace of government regulation. Let’s use this time to seriously consider how we can re-engineer what we do as professionals to truly communicate the value of our services. I’ll address those issues in my next post.


This is Part 22 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, Part 17, Part 18, Part 19, Part 20, and Part 21.


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 at[email protected]

Feature image by Ross Land/Getty, foot drop boot courtesy of rehab mart

  1. The following statement is not correct: “•The legislation must be passed by both houses of congress and signed into law by the President.” FDA can act on its own to create an OTC category.

    1. Thank you for pointing this out. I should have separated the legislative action from the FDA action. You are correct, of course – the FDA can create an OTC category under its rule-making authority but any changes must still be subject to a comment period. Depending on the nature of the changes, those in opposition can challenge the FDA in court arguing that the changes exceed the authority of the FDA (similar to court challenges in response to some EPA rules). The proposed legislation, however, goes far beyond simply requiring the establishment of such an OTC category – if passed and signed, the law will establish specific provisions associated with the creation of an OTC category to include, for example, prohibiting the states from establishing or continuing in effect “any law, regulation, order, or other requirement related to the manufacturing, marketing, sale, customer support, or distribution of over-the-counter hearing aids.”

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