OTC hearing aids promise to make hearing healthcare more accessible and affordable, but it's essential to remember that they are best suited for mild to moderate hearing loss. Professional guidance remains crucial for optimal outcomes.

Just about this time last year, I wrote an article for this magazine about the newly created FDA category of ‘Over-The-Counter’ (OTC) hearing aid that had been passed by Congress and signed into law the previous year. I wrote about the current state of affairs where, for quite a few years now, there has actually been an unregulated/’Wild West’ market of devices (collectively known as PSAPs–Personal Sound Amplification Products) that people have been purchasing (via catalogs, internet, etc.) to try and help them with their hearing difficulties. As it stands now, the FDA has until August 2020, with a period of time after for public comments, before the guidelines are finalized. Once the FDA publishes the final guidelines & requirements, some of these PSAPs will become “OTC Hearing Aids” effectively ‘overnight’.  

The impetus for OTC was that it would spur development in hearing aid technology, improve availability and reduce costs to consumers. The hope is that OTC will encourage people to begin treating their hearing loss with amplification sooner rather than later, where currently folks wait on average ~6 years or more to address hearing difficulties. Audiologically, the best short term results and long term prognosis entails treatment with amplification as early in the loss as possible. What the public needs to keep in mind though is that OTC hearing aids will ONLY be designated and appropriate to treat “mild to moderate” (high frequency) hearing loss. The research that supported making OTC hearing aids available for these (relatively) lesser degrees of hearing loss, was equally clear that OTC is not appropriate treatment for more significant hearing loss. So OTC, when properly used,  may be able to adequately address ‘early’ hearing loss, But… 

As an Audiologist, I know better than anyone how critical our care, expertise/knowledge and experience is when it comes to improving patient outcomes, overall communication and quality of life, now and in the future. Hearing aids, whether OTC or those dispensed by Audiologists, are just part of proper hearing healthcare. A critical part to be sure, and one that is always best served by someone with that expertise/knowledge/experience. There is a ceiling, as well as a range, to the benefit hearing aids can provide. It’s nerve damage, after all.  If not done or used properly, that ceiling may never be reached-or even approached!

In addition, though I spend a good amount of time programming and fine tuning hearing aid settings over several appointments, I spend just as much (sometimes even more) time with my patients counseling them about their hearing loss, showing them how to use/care for their devices, how to ‘stage’ communication situations and counsel others in ways to improve overall communication, to name just a few.   

  • Will people who try and fail (for whatever reason) with OTC seek professional help after, or will they think hearing aids can’t help when properly fit ones could?
  • Will folks with hearing difficulty due to issues in need of medical attention get that help in a timely manner, or wait longer to be identified?
  • Will the (inevitable) cases of user error create unintended issues/complications?

I do believe the potential benefits of OTC outweigh the potential pitfalls.

I’m guessing my practice will carry several of what I/my staff feel are the best devices. That way my patients will have a less expensive amplification option when appropriate, along with the other critical support component of good/proper hearing health care.

Do you know somebody that needs to see this? Why not share it?

Jonathan Lipschutz Audiologist, M.S., F-AAA, Owner

Jonathan is the owner of Berkeley Hearing Center. He received his bachelor of science in hearing and speech science and a master of science in audiology from Purdue University. He is a fellow of the American Academy of Audiology and the California Academy of Audiology. Jonathan has over 20 years of audiology and hearing aid experience in both the non-profit and corporate sectors.

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