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FDA to allow OTC sales of hearing aids

Hearing Loss Captions Everywhere
Posted at 6:34 AM, Aug 17, 2022
and last updated 2022-08-17 06:34:22-04

LEXINGTON, Ky. (LEX 18) — The FDA announced Tuesday that people will soon be able to purchase hearing aids over the counter. While people who work with the deaf and hard-of-hearing are optimistic that this could help bring prices down, they're also concerned that people might skip doctors altogether.

Virginia Moore, Executive Director of the Kentucky Commission on the Deaf and Hard of Hearing, said high costs are a big problem for people who need hearing aids.

"Hearing aids can be from one hearing aid $1,400 to $5,000 for just one hearing aid. If you need two, can you just imagine the cost? You have to take out a loan. It's an issue," she said

The Food and Drug Administration announced Tuesday a rule they say will improve access and they hope will lower costs by making certain hearing aids available over the counter.

Under the rule, people with perceived mild-to-moderate hearing impairment can buy the devices directly from stores or online without an exam or fitting. The ability to get the devices without a prescription certainly makes them more accessible for people who might need them, but Moore is concerned about the idea of cutting out a professional altogether.

"If your hearing is healthy and your ear is healthy, maybe then they can say, yes, go to the over-the-counter. Maybe low-to-moderate would work for you, and that's great because the cost would help, but you need to get it checked out first. Our fear is that people won't. They'll go get a hearing aid and wear it, amplify it, maybe it's not the right amplification," she said.

The rule will limit the maximum sound output of the devices to reduce the risk of further hearing damage, revise how deeply they can go into the ear canal, and require them to have user-adjustable volume control.

The hope is that the barrier to entry will be lower and that there will be more competition in the devices to drive down the cost to the consumer, and Moore says that's good - but ultimately, she says people need to be vigilant when it comes to protecting their hearing and having any issues checked out. If hearing loss is allowed to progress, she says other health problems could follow.

"We need to push people to see an audiologist, an ENT, we need to push people to go see a specialist to talk about the health of your ear first," Moore said.

The commission has a program to help people get devices that can do things like add captions to their phone calls. If you or someone you know needs those, you can get more information at KCDHH.ky.gov