What Caregivers Should Know about the FDA's Landmark Over-the-Counter Hearing Aids Rule

Chad Birt

Written by Chad Birt on Tue Sep 20 2022.

Judge and gavel to illustrate court ruling and rule of law

On August 16, the Food and Drug Administration (FDA) issued a final rule, allowing Americans to buy hearing aids without a medical exam, fitting, or doctor’s prescription. 

The rule—which creates a new class of over-the-counter hearing aids—promises easier access to listening devices, more affordable prices, and increased innovation in the hearing technology marketplace. 

OTC hearing aids have lots of potential, but the rush to produce cheap devices may also present risks. To better understand the FDA’s new hearing aids rule, and the potential challenges it presents, we contacted Hadassah Kupfer, Au.D., a doctor of audiology based in Brooklyn, New York. 

[Some of Dr. Kupfer’s responses have been condensed for clarity.]

Q) Before we get to the FDA’s new hearing aids rule, let's touch on hearing health and the aging process. Could you explain why hearing loss is so common in people 65 and older?

A) “The ears are working 24/7 - even when you sleep! The physical mechanism of the ear wears down day after day, and it wears out even more quickly if you have a noisy job or certain underlying medical conditions/genetics,” Dr. Kupfer said.

“Age-related hearing loss is gradual and you only begin to notice it once it builds up to a certain point. The "wear and tear" of 65 years of listening often results in hearing loss, and with time, strained listening may motivate someone to seek treatment in the form of hearing aids.”

Q) If I care for someone with hearing loss, when should I have their ears checked? And, as a follow-up question—how can I prevent the condition from worsening?

A) “It’s usually better to seek treatment for hearing loss before it becomes a big problem, like most medical conditions,” said Dr. Kupfer. 

“Even if you aren’t motivated to treat your hearing loss yet, get a baseline hearing test so you can monitor yourself year to year and decide whether you’re ready. Hearing loss often causes reduced social participation, which can in turn accelerate the aging process and dementia. Early detection and treatment are wonderful things.”

Q) How will the FDA’s new rule, establishing a new class of OTC hearing aids, benefit average consumers?

A) “The FDA’s new OTC hearing aids rule eliminates some barriers to care which may have otherwise prevented individuals from treating their hearing loss,” Dr. Kupfer said.

“For example, now there will be hearing aids at a lower price point, and one can avoid the time and cost associated with visiting a doctor to obtain them. This is helpful for people who are homebound or those who feel their issue is small, not requiring a comprehensive medical consultation.”

Q)If someone's thinking about buying OTC hearing aids, what are some things they should consider? Would you recommend meeting with an audiologist first? Why or why not? 

A) “It’s a great idea to see an audiologist first to rule out any wax or blockage issues or hearing problems that require urgent medical attention, and to get an accurate hearing test” said Dr. Kupfer. 

“Your audiologist should be able to inform you whether you’re a candidate for OTC hearing aids if that’s the route you are considering. Like most areas in life, some projects are more suited to DIY solutions than others. Likewise, each person needs to evaluate whether they’re willing to self-educate about hearing aid technology.

In a professional setting, you receive a customized recommendation and step-by-step guidance on using your hearing aids and successfully living with hearing loss.”

Q) Will OTC hearing aids provide the same quality of hearing assistance as their prescription counterparts? 

A) “If you have mild hearing loss or a mild perceived issue that only requires devices in certain situations, the OTC products may very well do the trick,” Dr. Kupfer said. 

 “For anyone who experiences daily disturbances from hearing loss, or severe hearing loss, you’ll likely do better with a customized solution that does more than just amplify the sound, such as sophisticated noise cancellation and precise adjustments based your prescription and listening preferences.”

Dr. Kupfer continued, “think of the beauty of a picture colored with 3 crayons, versus a picture colored with 24 crayons. The depth and resolution are so much greater with prescription hearing aids which actually have all these different ways of being adjusted for you.”

Q) Does the FDA's new hearing aids rule present any potential risks? For example, should caregivers be concerned about scams? 

A) “Absolutely, yes, and this market won’t be regulated as professional hearing aids are. For example, New York state law provides for a 45-day return/exchange period after purchasing hearing aids, to ensure that a person is succeeding with their treatment. Perhaps they need to switch to another model, and we have this grace period to protect the investment they've made,” Dr. Kupfer said.

“OTC devices may still cost several hundred or a few thousand dollars, without those protections. People must realize that just because something looks like a hearing aid on the outside, doesn't mean that the computer chip is of quality or that it will actually help them as they expect.”

Q) Is there anything else you’d like to add about hearing health or the FDA’s new OTC hearing aids rule?

A) Hearing health is so much more than a piece of equipment that you buy. The best hearing aid in the world can be horrible if it's fit on the wrong person,” Dr. Kupfer said.

“A professional opinion from a trusted source is key. Even if your friend had a certain experience with a particular hearing aid, it doesn't mean it will be the right or wrong model for you - since no two people experience hearing loss the exact same way. For maximum success, speak to your local audiologist!”

A big thank you to Dr. Kupfer for taking the time to answer our questions about the FDA’s new OTC hearing aids rule. If you want to learn more, you can access the FDA’s final document here.

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Chad Birt
Chad Birt

Chad Birt is a freelance B2B and B2C medical writer who resides in Astoria, Oregon. When he isn't behind a keyboard, you can find him hiking, camping, or birdwatching with his wife Ella and their two dogs, Diane and Thoreau.