People with mild or moderate hearing loss could soon be able to buy hearing aids without a medical exam or special fitting, under a new rule being proposed by the Food and Drug Administration. The agency says 37.5 million American adults have difficulty hearing.
"Today's move by FDA takes us one step 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 Services Secretary Xavier Becerra said as he announced the proposed rule on Tuesday.
There is no timeline yet for when consumers might be able to buy an FDA-regulated over-the-counter (OTC) hearing aid. The proposed rule is now up for 90 days of public comment.
The Hearing Loss Association of America, a consumer advocacy group, welcomed the proposal.
"This is one step closer to seeing OTC hearing devices on the market," Barbara Kelley, the group's executive director, said in an email to NPR. "We hope adults will be encouraged to take that important first step toward good hearing health."
The push for OTC hearing aids got a big boost in 2017
Advocates and lawmakers have been calling for OTC hearing aids for years, including in a big 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 now praising the FDA's move.
"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 driving down the cost for consumers," Warren and Grassley said in a joint statement to NPR. "This is terrific news."
The OTC hearing aid legislation was signed into law as part of the FDA Reauthorization Act of 2017. It states that the FDA "must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids."
But the law was followed by four years of public inaction. President Biden's recent executive order 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 to the FDA to urge immediate action.
The FDA has long required 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 must expend to get them. The new proposal would shake that arrangement up. The FDA says people who have trouble hearing will now face fewer hurdles to improving their lives.
On the market side of things, the FDA says the change will boost competition — and also put regulators' scrutiny on companies that aren't approved to sell hearing aids but are effectively already doing so by marketing "personal sound amplification products" (PSAPs).
A PSAP can look like and perform very similarly to a hearing aid, but it can be sold directly to consumers as a sound booster, ostensibly for people with normal hearing who just want a bit more volume. In the absence of OTC hearing aids, the devices have become established as an accessible alternative, as they don't entail getting a detailed hearing test or visiting an audiologist to calibrate a hearing aid. And while hearing aids can cost thousands of dollars, a PSAP is much cheaper, as NPR has reported.
Hearing loss takes a toll 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 it.
"The greater the hearing loss, the greater the risk of loss of thinking and memory abilities over time," Dr. Frank Lin, a researcher at the Johns Hopkins University School of Medicine, told NPR in 2017.
It's not just 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.
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