The FDA today announced its regulations for over-the-counter hearing aids, five years after Congress passed the Over-the-Counter Hearing Aid Act of 2017, which was signed into law by President Trump.
The regulations specify that these aids — which can be purchased at pharmacies, electronics stores like Best Buy, big-box stores or online — are for people with perceived mild to moderate loss. They are expected to be available as soon as October.
Those of us in the hearing-loss community are sure to be inundated with sales pitches and opinions, although most of us have severe enough hearing loss that OTC aids won’t help us. Here’s a link to an HLAA tip sheet on OTC aids. And here’s a link to the NIDCD’s new website on OTC aids.
And here’s a link to a post I wrote in October 2021, when the FDA first issued draft regulations. What Do Over-the-Counter Hearing Aids Mean for You. I’m going to reprint the post here, because It’s still relevant:
October 19, 2021:
Earlier this week, the FDA issued its long-awaited draft proposal on Over-the-Counter hearing aids. Over the counter means direct to consumer, without the intervention of an audiologist.
The FDA’s proposal followed four years of discussion about OTC aids, dating from the passage of the bipartisan Over the Counter Hearing Aid Act in August 2017. The FDA had three years to assess comments and proposals from stakeholders. These include consumer groups like The Hearing Loss Association of America and AARP, professional groups like the Academy of Doctors of Audiology (ADA) and and the American Association of Audiology (AAA), among others.
The FDA’s draft guidelines allow for adults 18 and over with “perceived” mild to moderate hearing loss to purchase hearing aids over the counter – online or at retail outlets – without a medical exam or a fitting by a hearing-aid professional. These non-prescription hearing aids will constitute a new class of FDA-approved hearing aids.
What we now think of as FDA-approved hearing aids – the prescription aids made by Phonak, Widex, Starkey, etc. for moderate to profound loss — will continue to require an audiologist or hearing-aid specialist for fitting.
Most readers of my column have fairly severe hearing loss and already have hearing aids or cochlear implants. Are these OTC hearing aids for you? No. But they will benefit us in other ways.
A lot more people will be wearing hearing aids. People who have hesitated up till now because they didn’t have access to an audiologist, or didn’t want to spend $5000-$6000 for a pair of hearing aids, or who simply didn’t want to wear hearing aids because of stigma, may find that their formerly “manageable” hearing loss is really not worth it if they can easily purchase a hassle-free lower priced aid. The more people who wear hearing aids, the more normal they become and so stigma begins to drop away.
A lot more people will be wearing aids for another reason as well. Demographics. More and more people are getting older every day, and with increased age generally comes increased hearing loss. Age-related hearing loss often begins as mild or moderate loss, and these OTC hearing aids may just right for those new to hearing aids.
As stigma drops away, so does secrecy. People with OTC hearing aids may realize that even with the aids, they prefer television with captions. If television, why not movies? If movies, why not town hall meetings? And so on. So demand for accessibility will grow. It will no longer be the relatively small group of people with moderate to severe or profound loss who are demanding accommodations.
Here are some things I hope will happen.
Although everyone should have a hearing test before buying any kind of hearing device, the work of audiologists may change. With fewer patients with mild to moderate loss, they may have more time for the kind of training and rehabilitation that people with more severe loss need. They may lobby to have insurance rules changed to allow reimbursement for training and rehab. Audiologists have a role even in OTC hearing aids. Having your hearing tested is not just to assess the degree of loss, it’s also to rule out potentially serious conditions like an auditory-nerve tumor or easily reversible conditions like ear wax. Perhaps a new model of audiology would allow a simple hearing evaluation for a fee.
Once hearing aids are divided into over-the-counter and prescription categories, insurers – including Medicare – may cover prescription aids, which serve a medical need. Or alternatively, with hearing-aid prices driven down by the competition of OTC aids, insurers may realize it’s wise to cover all hearing aids, which have a clear health benefit. Acting FDA Commissioner Janet Woodcock, M.D., was quoted in Hearing Health Technology Matters: “Hearing loss has a profound impact on daily communication, social interaction, and the overall health and quality of life for millions of Americans.”
For more on the FDA’s ruling, read HLAA’s comments here.
For more about living with hearing loss, read my books “Smart Hearing: Strategies, Skills and Resources for Living Better With Hearing Loss” and “Shouting Won’t Help: Why I and 50 Million Other Americans Can’t Hear You.” Both are available as ebook and paperback on Amazon.com.