FDA moves to make over-the-counter hearing aids available to millions

The Food and Drug Administration is moving to corroborate over-the-counter hearing aids in a alter that lawmakers and advocates have long chosen for. Hither, a man displays his hearing help before taking role in a meeting. Keith Bedford/Boston Globe via Getty Images hide caption

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Keith Bedford/Boston Earth via Getty Images

The Food and Drug Administration is moving to approve over-the-counter hearing aids in a alter that lawmakers and advocates have long chosen for. Here, a man displays his hearing aid before taking part in a meeting.

Keith Bedford/Boston World via Getty Images

People with mild or moderate hearing loss could soon be able to buy hearing aids without a medical examination or special fitting, under a new rule being proposed by the Food and Drug Administration. The bureau says 37.v 1000000 American adults have difficulty hearing.

"Today's movement by FDA takes united states i footstep closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss," Health and Human being Services Secretary Xavier Becerra said as he announced the proposed rule on Tuesday.

There is no timeline yet for when consumers might exist able to buy an FDA-regulated over-the-counter (OTC) hearing aid. The proposed rule is at present up for ninety days of public annotate.

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

"This is one step closer to seeing OTC hearing devices on the market," Barbara Kelley, the group's executive managing director, said in an email to NPR. "Nosotros hope adults volition be encouraged to take that important first step toward skilful hearing health."

The button for OTC hearing aids got a big boost in 2017

Advocates and lawmakers accept been calling for OTC hearing aids for years, including in a large push in 2017, when Sen. Elizabeth Warren, D-Mass., and co-sponsor Sen. Chuck Grassley, R-Iowa, introduced the bipartisan Over-the-Counter Hearing Aid Act. The legislators are at present praising the FDA's motion.

"Presently, millions of people with balmy to moderate hearing loss volition finally accept lower cost hearing help options — and more options hateful more competition in the market, further driving down the cost for consumers," Warren and Grassley said in a joint argument to NPR. "This is terrific news."

The OTC hearing assist legislation was signed into law equally part of the FDA Reauthorization Act of 2017. It states that the FDA "must categorize sure hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids."

But the law was followed past 4 years of public inaction. President Biden'due south recent executive society on "Promoting Competition in the American Economy" singled out hearing aids as an area where families are paying overly high prices for necessities — and Warren and Grassley sent a letter of the alphabet to the FDA to urge immediate action.

The FDA has long required prescriptions for hearing aids

For decades, the FDA has regulated hearing aids every bit prescription medical devices — an organisation that adds to the cost and effort people must expend to become them. The new proposal would shake that organization up. The FDA says people who have problem hearing volition now face fewer hurdles to improving their lives.

On the market side of things, the FDA says the modify will boost competition — and as well put regulators' scrutiny on companies that aren't approved to sell hearing aids but are effectively already doing so past marketing "personal sound distension products" (PSAPs).

A PSAP tin can look like and perform very similarly to a hearing aid, only information technology can be sold direct to consumers as a sound booster, ostensibly for people with normal hearing who just want a bit more book. In the absence of OTC hearing aids, the devices have become established as an accessible culling, as they don't entail getting a detailed hearing test or visiting an audiologist to calibrate a hearing aid. And while hearing aids tin toll thousands of dollars, a PSAP is much cheaper, equally NPR has reported.

Hearing loss takes a price on millions of Americans

Hearing loss has been linked to cognitive decline and other health problems in older people and can bring a sense of insecurity and isolation to someone experiencing information technology.

"The greater the hearing loss, the greater the risk of loss of thinking and retentivity abilities over time," Dr. Frank Lin, a researcher at the Johns Hopkins University School of Medicine, told NPR in 2017.

It's not only the elderly who are having trouble hearing. One in 5 teenagers experiences hearing loss to some degree, according to the Hearing Loss Association of America.

Source: https://www.npr.org/2021/10/19/1047303559/fda-hearing-aid-prescription-over-the-counter

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