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The Food and Drug Administration is set to approve over-the-counter hearing aids in a change that lawmakers and advocates have long been calling for. Here, a man shows off his hearing aid before joining a meeting.

Keith Bedford / Boston Globe via Getty Images


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Keith Bedford / Boston Globe via Getty Images

The Food and Drug Administration is set to approve over-the-counter hearing aids in a change that lawmakers and advocates have long been calling for. Here, a man shows off his hearing aid before joining a meeting.

Keith Bedford / Boston Globe via Getty Images

People with mild to moderate hearing loss may soon be able to purchase hearing aids without a medical exam or special hearing aid, under a new rule proposed by the Food and Drug Administration. The agency says 37.5 million American adults have difficulty hearing.

“Today’s decision by the FDA brings us closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people with mild to moderate hearing loss,” said Xavier Becerra, secretary of the Health and Social Services. announced the proposed rule Tuesday.

There is no timeline yet for when consumers could purchase an FDA-regulated over-the-counter (OTC) hearing aid. The proposed rule is now in effect for 90 days of public comment.

The Hearing Loss Association of America, a consumer advocacy group, welcomed the proposal.

“This is one more step towards bringing OTC hearing aids to the market,” Barbara Kelley, executive director of the group, said in an email to NPR. “We hope that adults will be encouraged to take this important first step towards good hearing health.”

The surge in over-the-counter hearing aids boomed in 2017

Advocates and lawmakers have been calling for over-the-counter hearing aids for years, including during a big push in 2017 when Senator Elizabeth Warren, D-Mass. the law on over-the-counter hearing aids. Lawmakers are now praising the FDA’s decision.

“Soon, millions of people with mild to moderate hearing loss will finally have lower-cost hearing aid options and more options mean more competition in the market, further reducing costs for consumers,” said Warren and Grassley said in a joint statement to NPR. “That’s excellent news.”

The legislation on over-the-counter hearing aids has been signed in law under the FDA Reauthorization Act of 2017. It states that the FDA “shall classify certain hearing aids as over-the-counter hearing aids and issue regulations regarding such hearing aids.”

But the law was followed by four years of public inaction. President Biden’s recent decree on “Promote competition in the US economy“Has pointed out hearing aids as an area where families are paying too high prices for basic necessities and Warren and Grassley have sent a letter to the FDA urging immediate action.

The FDA has long demanded prescriptions for hearing aids

For decades, the FDA has regulated hearing aids as prescription medical devices, an arrangement that adds to the cost and effort people have to put in to obtain them. The new proposal would upset this arrangement. The FDA says people who have hearing problems will now face fewer barriers to improving their lives.

On the market side, the FDA says the change will boost competition and also put regulators’ control over companies that are not licensed to sell hearing aids but already do so by marketing “personal sound amplification products.” (CASP).

A PSAP can look and function very similar to a hearing aid, but it can be sold directly to consumers as a sound amplifier, apparently for people with normal hearing who just want a little more volume. With no over-the-counter hearing aids, the devices have established themselves as an accessible alternative because they don’t involve taking a detailed hearing test or seeing an audiologist to calibrate a hearing aid. And while hearing aids can cost thousands of dollars, a PSAP is much cheaper, as NPR reported.

Hearing loss wreaks havoc on millions of Americans

Hearing loss has been linked to cognitive decline and other health problems in the elderly and can bring feelings of insecurity and isolation to a person who suffers from it.

“The greater the hearing loss, the greater the risk of loss of thinking ability and memory over time,” Johns Hopkins University School of Medicine researcher Dr. Frank Lin told NPR in 2017.

It’s not just the elderly who have difficulty hearing. One in five teens suffer from hearing loss to some extent, according to the Hearing Loss Association of America.




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