Good news from the FDA this week—our first look at proposed rules for over-the-counter (OTC) hearing aids. The rules look promising, allowing for flexibility in product design and distribution method combined with needed regulation and labeling to ensure product safety.
Hearing Loss Association of America, the largest consumer organization representing people with hearing loss in the United States, issued the following statement:
“The Hearing Loss Association of America (HLAA) is pleased to see the proposed rules on over-the-counter hearing aids published today by the FDA. This is one step closer to seeing OTC hearing devices on the market for adults with mild to moderate hearing loss. We hope adults will be encouraged to take that important first step toward good hearing health. HLAA will comment on the proposed rules within the 90 days.”
My take: While not appropriate for everyone, OTC hearing aids fill an important gap in the marketplace for hearing care. Their emergence should spark a wave of innovation and price competition, perhaps even jumpstarting a communication specialist approach to audiological care.
Increased options for hearing devices could also lead to increased uptake and reduced stigma.
Once OTC aids are available—most likely Fall of 2022—millions of American adults with perceived mild to moderate hearing loss will benefit from increased availability of high-quality reasonably-priced devices to help them hear better. I can’t wait!
Why Should You Care about OTC Hearing Aids?
Slow down, you might say. Why should I care about OTC devices? If I have severe or profound hearing loss, these devices will not work for me. True, but there are still many reasons for excitement.
1. Increased Competition
More competition is typically good for consumers, often sparking innovation and lowering prices. Large consumer electronic companies are eager to enter the hearing space and many already have. For example, earlier this year, Bose launched an OTC hearing aid. Apple does not (yet) market its AirPods Pro as hearing aids, but they function like ones in certain situations.
Products like these put extra focus on hearing enhancement in difficult listening situations, pushing traditional devices to up their game as well.
A new OTC channel will likely push traditional hearing aid companies to broaden their product assortment too. I expect they will create lower priced offerings marketed under different brand names that include streamlined features for the mild to moderate hearing loss consumer. As competition picks up in both channels, people with hearing loss will benefit from a wider array of offerings at a variety of price points.
2. Reduced Stigma
As using hearing assistance become more commonplace, the stigma surrounding hearing devices will lessen for everyone. And as people become accustomed to hearing better in difficult listening situations, demand for accommodations like hearing loops and closed captioning could grow too, boosting access for all of us.
3. More Service-Oriented Audiologists
With devices available across multiple channels, the audiologist role will evolve into that of a communication specialist. Expertise in rehabilitation, counseling, and the softer side of hearing loss (non-technical skills like self-advocacy) will take center stage. With higher demand, perhaps these services will even be covered by insurance over time.
4. Enhanced Focus on Hearing Health
Healthy hearing is a critical part of our overall health, but it is easy to ignore, leading to isolation, depression, and even a higher chance of developing dementia. While some people with mild to moderate hearing loss refuse to use hearing aids due to their high cost or stigma, OTC options may be more appealing.
The industry needs to meet consumers where they are. Greater use of communication devices, regardless of their form, keeps people connected and engaged, boosting their well-being and overall health.
5. An Emergency Back-up Pair
OTC devices are not made for people with severe to profound hearing loss, but they could function as back-up devices in a pinch should existing hearing aids go missing or need repairs.
Yes, We Still Need Audiologists
Critics worry consumers could do more harm than good to their hearing with OTC devices. They wonder if consumers can safely manage their devices without the help of a trained professional. While studies show that consumers are often able to self-fit effectively, people with severe or profound hearing loss will probably always require the expert assistance of a trained professional and the most sophisticated of hearing devices.
For people with mild to moderate hearing loss, a more hybrid approach seems possible. My hope is that audiologists will embrace OTC hearing aids, welcoming everyone who desires to hear better into their practices. When the overall market grows, everyone benefits.
Shari Eberts is a hearing health advocate, writer, and avid Bikram yogi. She is the founder of Living With Hearing Loss, a blog and online community for people living with hearing loss and tinnitus. She also serves on the Board of Trustees of Hearing Loss Association of America. Shari has an adult-onset genetic hearing loss and hopes that by sharing her story she will help others to live more peacefully with their own hearing issues. Connect with Shari: Blog, Facebook, LinkedIn, Twitter.