Concerns over FDA’s plan to allow over-the-counter hearing aids

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GRAND RAPIDS, Mich. (WOOD) – The Food and Drug Administration has unveiled a plan to allow the purchase of hearing aids without a prescription.

More than 37 million Americans have trouble hearing, but only one in five who need hearing aids actually use them, according to the agency.

Local specialists like Dr Brittany Finkler of McDonald Hearing Services are concerned about over-the-counter hearing aids.

“A lot of these devices we in the field call a blanket amplifier,” Finkler said.

Finkler herself uses hearing aids and says the process is more complicated than just amplifying the sound.

“It’s not like you take anything and lift it, that would solve their problem. They really need something digital that we can sort of pick and choose where they need help, ”Finkler said.

Audiologists perform hearing tests using calibrated equipment in a soundproof booth. Finkler is concerned that home tests using headphones may not provide accurate results.

“We can get a more direct and valid test by doing it this way versus someone listening to headphones in their living room, and we don’t know if the dog is barking in the background or if there are kids screaming while they’re running, ”Finkler said.

Deb Atwood of Kentwood Deaf and Hard of Hearing Services is concerned about communication issues when ordering or fitting hearing aids.

“Many of our deaf, deafblind and hard of hearing wear hearing aids, but their first language is still American Sign Language,” Atwood said. “If they go to OTC, in an OTC framework, how are they going to have access to an interpreter? “

Dr Karen Jacobs, an audiologist who also works with the Lion’s Club to help people pay for hearing aids, says people might think the hearing loss is mild, but it’s actually more serious.

“I think it’s fantastic to have a lower cost option for people. My real problem is with the regulations or the rules or regulations as they are written now is that they remove all surveillance, there is no medical clearance, there is no hearing test Jacobs said. “Moderate hearing loss is 50% hearing loss. If you have moderate hearing loss, it has been a long time since you had normal hearing.

The FDA is accepting public comments on the proposal and plans to finalize the regulations soon.

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