Over-the-counter hearing aids could be available as early as October: NPR
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Adults with perceived mild to moderate hearing loss will be able to buy hearing aids directly from stores, pharmacies and online retailers — without a prescription or doctor’s appointment — starting in mid-October.
It’s because of one last rule released Tuesday by the U.S. Food and Drug Administration and set to take effect in two months, after years of campaigning by lawmakers and advocates. It creates a new category of over-the-counter hearing aids, which the Biden administration says will make devices more accessible and affordable for millions of Americans.
The new rule only applies to certain air conduction hearing aids for people aged 18 and over who have a mild to moderate hearing loss, meaning those intended for pediatric use or serious hearing aids will remain prescription devices. It also does not apply to “personal sound amplification products”, consumer products that help people with normal hearing amplify sounds.
Hearing loss can complicate communication and contribute to social isolation, and researchers have also linked it to walking problems, falls, dementia and the Depression. Some 30 million American adults could benefit from using hearing aids, according to the FDA. And even, only about 14% of hearing-impaired Americans actually use them.
Rule will reduce costs and expand access
Until now, the high cost of hearing aids and examinations, which are not covered by basic health insurance – has been prohibitively expensive for many people. Devices alone typical range from $1,000 to $6,000 per ear, and consumers have to spend more time and money getting a specialist to examine and fit them (even if the says the White Houseexperts say a medical evaluation is not necessary).
The Biden administration estimates the new rule will reduce the cost of hearing aids by hundreds, if not thousands of dollars. FDA Commissioner Robert Califf told reporters during a press call that the FDA works with manufacturers to ensure that over-the-counter devices are of “good quality” and meet the agency’s performance criteria.
It can also make the market more competitive
The administration is also touting the move as one that will reduce red tape while promoting innovation and competition in a highly concentrated market.
A investigation report published by Sens. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., in June revealed that the top five hearing aid manufacturers control more than 90% of the market.
Grassley and Warren have been campaigning for over-the-counter hearing aids since 2017, when they introduced the bipartisan Over-the-Counter Hearing Aids Act.
Congress passed this proposal at the time, but the Trump administration, the FDA, has not released the rules that would actually allow these devices to be sold directly to consumers. It is being implemented now due to the July 2021 “Executive Order on Promoting Competition in the American Economy,” in which Biden called on the FDA to take action on over-the-counter hearing aids within 120 days (among a variety of other provisions).
The ruler was years in the making
The FDA released the proposed rule in October and made several changes to the final version after reviewing more than 1,000 public comments.
Grassley and Warren’s report found that hearing aid manufacturers and their allies were backing “astroturf campaigns” to distort public perception around the proposed rule, launching letter-writing campaigns that accounted for nearly 40 % of all comments publicly available.
The senators applauded the FDA’s announcement, saying in a statement that they “urged the FDA to act every step of the way – holding Republican and Democratic administrations accountable – and retaliated against entrenched special interests.” .
If you are considering buying over-the-counter hearing aids yourself, check out these tips of the Hearing Loss Association of America.