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As the publication of the Over the Counter (OTC) Hearing Aid Act of 2017 proposed regulations draws near, I am consistently asked “what do you think the Food and Drug Administration will do?”. While I DO NOT have ANY answers, I do have some thoughts, based upon years of experience and research, regarding things I expect to see in the proposed regulations and what things would not surprise me. Please note that I have no inside or definitive information; just speculation like the rest of us.
Here is what I do know, the FDA and federal legislators are being HEAVILY lobbied on all sides of this issue. The proposed rules will give us a glimpse as to whether those millions of lobbying dollars were well spent.
Now, here is what I EXPECT to see:
- Creation of a separate class of hearing aid specific to over the counter and direct to consumer hearing aids.
- Define what constitutes an “over the counter hearing aid”.
- Include output and gain limits.
- Restrict purchase to those 18 years of age and older.
- No medical clearance, medical waiver or audiometric testing requirement.
- Require an open access software platform (can be programmed or adjusted by anyone).
- Require return for credit capacity, regulated by the Federal Trade Commission (FTC).
- Removal of the current medical clearance and medical waiver requirement for all adult hearing aid purchases, irrespective of the class of the hearing aid.
- Require a printed user brochure be supplied with every hearing aid purchase, irrespective of the class of the hearing aid.
Now, here is what I might not be SURPRISED to see emerge:
- Greater FTC engagement in the industry.
- Reconfiguration of the entire classification system for hearing aids, including the current Class I and Class II devices, over the counter devices, and personal sound amplification products.
- Requirement for price transparency/itemization, where the purchaser is presented the hearing aid and durable medical equipment costs separate from the costs of the evaluation, fitting, and long-term care services. This would be regulated by the FTC.
- Requirement for audiometric prescription from an audiologist or physician (consistent with the Eyeglass Rule in optometry) prior to the purchase of a non-OTC hearing aid. This would include otoscopy and pure-tone audiometry. This too would be regulated by the FTC.
- Eliminate all manufacturers limitations on the sale of hearing aids as long as the FDA and/or FTC regulations are met. This could allow for the remote, direct to consumer delivery of every class of device, using telehealth. This too is consistent with the Eyeglass and Contact Lens Rules.
- Require an open access software platform (can be programmed or adjusted by anyone).
- Require return for credit capacity, regulated by the Federal Trade Commission (FTC), which does not currently exist in FDA regulations or in every state hearing aid dispensing law.
- Require greater pre-market approval for new and emerging technologies.
The by-product of these changes will mean that most, if not all, state hearing aid dispensing laws will need to be drastically overhauled to reflect these changes. The bipartisan OTC Act, which was passed and signed during the Trump administration in 2017, clearly indicates that no state law can be more restrictive than the federal regulations.
In a practical sense, these are the changes audiologists need to make TODAY to be ready for OTC regulations that will go into effect in 2022:
- ADVOCATE and ENGAGE in your profession! Join your state audiology association. These entities need members and membership dollars to fund the lobbyists needed to rewrite state dispensing laws.
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Experience the emerging technologies before you judge them and bring the ones into your practice that can fill a niche. Learn about these new technologies, such as those offered by Nuheara, Apple, Bose, BeHear, Olive Union, and many other new entrants into the space. Try them out. Test them. Be open to how these devices can help a contingent of your patients.
- Evolve your care and delivery models and become EVERYTHING (evaluation, fitting, verification, rehabilitation, treatment, long-term care) that OTC solutions can never be!
- Reconfigure your practice to focus more on care and expertise and less on the product.
- KNOW the value of your time and expertise and create a transparent pricing structure that reflects your care and dispensing philosophies and financial goals.
- Follow the science. Read peer reviewed journal articles. Attend webinars and conventions other than is sponsored by manufacturers. LEARN MORE! I see so much misinformation and propaganda out there about amplification that is spread by fellow audiologists.
- YOU DO YOU! Run your own businesses and do not depend on outsiders, with their own agendas, to run your practices and help you succeed!
All I see ahead are opportunities for audiology! We just have to evolve our 1970s evaluation model, our 1990s fitting model, and our 1960s pricing model to reflect changes in technology and the needs and desires of today’s consumers. I have clients and colleagues who have already made this leap and, as a result, have growing, thriving, financially stable audiology practices, with a strong focus on treatment of hearing loss and amplification. These practices are READY for whatever lies ahead! The question remains: How READY are YOU?
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