Hearing aids could be available over the counter as soon as October

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People with mild or moderate hearing loss should be able to buy hearing aids over the counter as soon as mid-October, and they will not need a doctor's exam or a prescription to buy them. That's because of a new rule from the Food and Drug Administration designed to make hearing aids more accessible and ultimately more affordable for many consumers. NPR's Maria Godoy reports.

MARIA GODOY, BYLINE: Hearing loss affects more than 40 million Americans, according to recent estimates. But the vast majority of them don't have hearing aids, even though they need them.

FRANK LIN: A lot of that is because of hearing aids being really expensive.

GODOY: Dr. Frank Lin is a professor of otolaryngology at Johns Hopkins School of Medicine.

LIN: I mean, the average cost of care of hearing aids can be, you know, around $4,000.

GODOY: And that cost is often not covered by insurance. Lin says one factor behind the high prices is that, until now, hearing aids were regulated as medical devices that could only be bought from a licensed provider like an audiologist. That limited the number of companies manufacturing hearing aids. He says consumer tech companies that already make earbuds with similarly sophisticated components couldn't enter the market.

LIN: We've had this very constrained market where essentially you have five manufacturers that control about 95% of the world's hearing aid marketplace.

GODOY: But Health and Human Services Secretary Xavier Becerra says new FDA rules are designed to change that.

XAVIER BECERRA: Today, the FDA opens the door to quality, affordable hearing aids to consumers over the counter. And the operative word here is over the counter.

GODOY: The rules create a new class of hearing aids that can be sold in retail stores and online without a prescription or special evaluations. Brian Deese, White House director of the National Economic Council, says the goal is to make it easier for more manufacturers to enter the market and encourage competition.

BRIAN DEESE: We expect that that competition will drive down costs. In fact, the FDA estimates this rule will save consumers on the order of about $1,400 per individual hearing aid or over $2,800 per pair.

GODOY: But ultimately, advocates say the new rule change isn't just about business innovation. Frank Lin of Johns Hopkins says research shows hearing loss can have profound impacts on health. Not being able to hear well or hearing only garbled sounds can lead to social isolation, and it may also cause changes to the brain.

LIN: Hearing loss is arguably the dominant factor for dementia. The actual fact of hearing loss, that auditory deprivation of the brain could actually lead to parts of the brain shrinking and atrophying faster because it's being stimulated less.

GODOY: But these are risk factors that may potentially be lessened by a good hearing aid. Maria Godoy, NPR News. Transcript provided by NPR, Copyright NPR.