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OTC Hearing Aids – A Game Changer for Mild to Moderate Hearing Loss

January 5, 2022 by Staff Writer

A mother, father, and two children laying together in a hammock smiling

Download: “Consumer reaction to OTC hearing aids” by Akoio. This white paper examines survey results from 500 Americans (n=500) regarding recent FDA regulation for OTC hearing aids.

The dictionary defines progress as development, advancement, or improvement, as toward a goal. Progress was made last year when the Food and Drug Administration (FDA) proposed (finally) a rule to establish a new category of over-the-counter (OTC) hearing aids. This ruling will catapult life-changing, hearing technology into action allowing sound pioneers like Bose and Lucid Audio to create more affordable, specially designed solutions for those experiencing hearing loss. Given the timeliness of the ruling, Akoio conducted a survey that examined the public’s general knowledge of OTC hearing aids and its attitude towards them. The results allowed us to publish an informative white paper exploring consumer responses to the new FDA rule regarding OTC hearing aids.

Studies from the National Institutes of Health show that “80% of those who would benefit from a hearing aid, do not use them” (see “Quick Statistics About Hearing” and “Why do people fitted with hearing aids not wear them?”). It’s fair to ask the question, why not offer a more affordable and accessible option for people who know they have some hearing loss, but haven’t gone to an audiologist or don’t wear their hearing aids? These are the barriers that the new FDA ruling addresses.

Think of it like your OTC reading glasses

Man trying on reading glasses at the drugstore

OTC hearing aids would work something like OTC reading glasses. If someone’s having trouble reading print on their phone or on paper, their first stop is often the nearest drugstore to try on “readers” aka “cheaters.” This means they can get immediate help to improve their vision, without a visit to the eye doctor. But for those with early-stage hearing loss, there is currently no OTC option and a visit to the audiologist seems like overkill. So, they choose to wait. But waiting has consequences. Hearing loss may get worse faster than it might otherwise. Or a person may needlessly experience an increase in isolation, anxiety, or even dementia, that might have been prevented or mitigated by using hearing aids.

Computer key showing the word Feedback. Message on keyboard key.

The OTC hearing aid survey

To better understand what the general public thinks about OTC hearing aids, we surveyed 500 people living in the United States and asked questions surrounding the topic. The answers helped illustrate the importance of offering lower cost hearing aids without the need for a doctor’s visit. This route is not for everyone, as the survey concluded, but it is a desirable option for about half of the population with mild to moderate hearing loss.  

In the dark with hearing loss

Among survey participants, about 1 in 4 said they experience some hearing loss. Of those, 74% reported having mild to moderate hearing loss while 26% identified as having severe hearing loss. Furthermore, despite growing awareness of hearing health, both groups reported low awareness of OTC hearing aids.

To educate participants, Akoio provided the following:

“In 2017, the U.S. Congress passed a new law that would allow hearing aids to be purchased without a prescription. These ‘over-the-counter’ (OTC) hearing aids are expected to be less expensive than hearing aids prescribed by a doctor or professional audiologist.

Such ‘over-the-counter’ (OTC) hearing aids can be made available once the (FDA) establishes guidelines for them. These guidelines were expected in 2018, but have been delayed. The White House recently signed an executive order encouraging the FDA to establish guidelines by the end of 2021.”

Tell me more about OTC hearing aids

The survey then asked if participants would consider purchasing an OTC hearing aid. More than 70% of those with hearing loss responded positively. Additionally, about 40% of those without hearing loss said they, too, would consider purchasing an OTC hearing aid to help them address any future hearing loss. These numbers are extremely powerful and encouraging for those of us passionate about hearing wellness. The market seems ready for an OTC hearing aid option, and it’s a game changer for those with mild to moderate hearing loss.

A senior male patient listens attentively as a female nurse reviews his medical documents. They are standing at the check-in window in the medical clinic.

Do I need to ask my doctor

Interestingly, but not surprisingly, there is apprehension that surrounds purchasing an OTC hearing aid without direction from a doctor or audiologist. Among those not currently experiencing hearing loss, 42% said they would only purchase an OTC hearing aid if it was recommended by their doctor. Thirty-seven percent of those with hearing loss shared that attitude. On the flip side, these numbers indicate that nearly half of people, regardless of hearing ability, don’t require direction from a hearing loss specialist.

Willingness to try or buy an OTC hearing aid without consulting a doctor may also depend in part on how “tech savvy” the consumer considers themselves to be. About 40% of participants with hearing loss said they already use earbuds (separate devices from hearing aids) to manage background noise or amplify sound, and nearly half of that group said they would likely forgo a doctor recommendation before purchasing an OTC hearing aid. 

The survey data exposed what we hypothesized. Existing hearing aid users, understandably, appear to be comfortable with the status quo. They’ve already deemed their hearing loss “severe enough” to pay the high costs, both emotionally and financially, of getting a hearing aid via consultation with a “licensed professional” (ENT physician, audiologist, hearing aid technician). But many others won’t wear a hearing aid until their hearing becomes “bad enough” to justify going to a doctor. These consumers can be reluctant to try traditional hearing aids because of expense, social stigmas, or simply because they do not like the functionality or comfort of a prescription device. 

OTC hearing aids can help conquer life

Infographic that asks the reader if they are thinking about hearing loss and let's them know they aren't alone.

The promise of over-the-counter hearing aids is less about converting existing hearing aid users and more about providing solutions for a large, underserved population with mild to moderate hearing loss (or with situational hearing loss). In our blog, “Thinking about hearing loss?”, we summarized an Akoio study that found the majority of respondents delayed using hearing aids because they weren’t mentally ready and didn’t feel their hearing loss was at a stage that warranted assistance. Unfortunately, delaying diagnosis doesn’t allow a person to fully mitigate the known harmful effects of hearing loss such as loneliness, isolation, decreased cognitive function, or even dementia. 

As we take more control of our health, including our hearing health, OTC hearing aids will become game changers for hearing wellness and healthcare. Let’s normalize hearing loss and allow people as much access as possible so that they can conquer life! 

Founded by President & CEO Bill Schiffmiller, Akoio is dedicated to providing products and services tailored to the needs of people with hearing loss. A life-long hearing aid user and hearing wellness advocate, Bill was the former Accessibility Advocate for Apple, Inc., and received his Master of Professional Studies degree in Design Management at Pratt Institute. © 2022 Akoio Enterprises, Inc.

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