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F.D.A. Clears Path for Hearing Aids to Be Sold Over the Counter

The Food and Drug Administration ruled Tuesday that hearing aids may be sold to adults without a prescription, a long-held wish of consumers frustrated by expensive exams and devices.

The high cost of hearing aids, which are not covered by basic health care, has discouraged millions of Americans from purchasing the devices. Health experts say untreated hearing loss can contribute to cognitive decline and depression in older people.

Under the new FDA rule, people with mild to moderate hearing loss should be able to purchase hearing aids online and in stores as early as October, without having to see a doctor for an exam to get a prescription.

The agency cited studies that estimate that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could turn the market, which is dominated by a relatively small number of manufacturers, upside down and make it a broader field with less expensive and perhaps more innovative designs. The cost for hearing aids, which usually includes visits with an audiologist, ranges from about $1,400 at Costco until about $4,700 or more.

“This could fundamentally change technology,” said Nicholas Reed, an audiologist in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies are coming up with. We can literally see new ways hearing aids work, what they look like.”

The FDA’s final rule goes into effect in 60 days. Industry representatives say device makers are largely ready to launch new products, although some may need time to update labeling and packaging or comply with technical details as a rule.

dr. Robert Califf, the FDA commissioner, said the move is intended to “unleash the power of US industry” in a way that could have global impact.

“Hearing loss has a profound impact on daily communication, social interaction and overall health and quality of life for millions of Americans,” said Dr. Califf during a press conference. “This is a huge global problem where I think American ingenuity can make a huge difference.”

The hearing aid change eliminates the need to see an audiologist for a hearing exam and fitting, a process not often covered by insurance. Federal officials estimate a $2,800 savings on the cost of a pair of hearing aids. Brian Deese, White House director of the National Economic Council, said making the change was a “top priority” for the president.

“This is going to make a very tangible difference in the lives of millions of Americans,” said Mr. deese.

Whether it will make a difference in the voting booth remains to be seen, said Jonathan Oberlander, a professor of health policy at the University of North Carolina. He called the FDA’s move a “consolation prize” of sorts, given Democrats’ failed attempts to extend basic health care to vision, dentistry and hearing. The upside, however, is that some hearing aids should be on store shelves by the time the voting kicks in.

Hearing loss is associated with: Dementia, isolation and other health problems in older adults. But the barriers to getting hearing aid include costs not covered by Medicare. There is also stigma – like appearing “old” – that comes with the usage.

April Shrum, 45, of Bremerton, Wash., has been willing to get hearing aids for years but has been unable to get them covered by her insurance. She said that about ten years ago while training to go to Iraq, she lost some hearing when firing guns. But her hearing loss was never tested to a level that qualified her for coverage.

“I don’t need a prescription for them,” said Mrs. Shrum, “which means I can buy them myself and it’s fantastic.”

A broader appreciation of the importance of acute hearing for adults is strange: A recent study found that people aged 50 to 80 were twice as likely to take their pet to the vet in the next year than to have their hearing checked.

“It kind of breaks my heart,” said Sarah Sydlowski, associate chief improvement officer of the Cleveland Clinic’s Head and Neck Institute and lead author of the study. “I think our biggest challenge as a profession and as a healthcare system is to make sure people understand that hearing is incredibly important. It deserves their attention, it deserves their action.”

The over-the-counter shift has confused some of the nation’s audiologists, the professionals who guide people through choosing the best hearing aid, adjusting settings, and achieving the right fit. The new step eliminates the long-standing requirement that consumers begin the process of getting a hearing aid with them. But some in the business see opportunities.

“The hearing care professional is not going to disappear,” said Barbara Kelley, executive director of the Hearing Loss Association of America, a consumer group. “The over-the-counter rule opens up a new avenue that is huge for adults with mild to moderate hearing loss to take that step sooner rather than later. And we’re really excited about that.”

The change has been going on for years. In 2016, a proposal for the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing was released in a report by the National Academies of Science, Engineering and Medicine. The following year, Senators Chuck Grassley, an Iowa Republican, and Elizabeth Warren, a Massachusetts Democrat, introduced a bill that would allow the agency to make the change. Congress passed the legislation and President Trump signed it into law.

Finalizing the regulation has been slow since then, with some conflict over details, such as how the federal rule would interact with state laws about hearing aid returns or warranty policies and how much the devices must amplify sound.

Mr. Biden issued an executive order last July calling for more competition in the economy, urging the FDA to take action “to promote the wide availability of low-cost hearing aids.”

That rule was enacted in the fall of 2021, followed by a period of public comment. The Hearing Industries Association, an industry group, has a 45-page comment letter The FDA warned of companies entering the market in 2018, after the original law passed, that sold hearing aids that were “ineffective, of poor quality, and in some cases dangerous.” The organization gave detailed advice on how to avoid a recurrence scenario.

“We applaud the move to increase access to care for those with problems and encourage them to seek a professional,” said Kate Carr, president of the trade group. Other organizations expressed concern that the FDA would create a safety problem by allowing new hearing aid manufacturers to develop devices that allow users to hear loud sounds.

Senators Warren and Grassley released a joint report accusing the makers of “dominant hearing aids” of engaging in “astroturf lobbying” by flooding the FDA with repeated comments that would send the agency to a new generation of hearing aids that “would be less effective, exceeding the existing market share of the manufacturers would protect and maintain their competitive advantage.”

The logic is simple: The less effective an OTC hearing aid is, the more likely consumers will be forced to forgo these options and instead opt for more expensive prescription devices sold by the manufacturers that power this industry. dominate,” the senators’ inquiry said. report said.

The FDA reviewed more than 1,000 submitted comments on the rule and made a handful of changes to the final version released Tuesday. They include lowering the maximum sound output of the devices and revising the limit for insertion depth into the ear canal. The rule also requires the hearing aids to have user-adjustable volume controls and simplified text on the product label.

John Prouty, 65, said on Tuesday he would keep a close eye on changes in hearing aids. He said he recently had a test and found that he had some hearing loss.

“I don’t think it has had a huge effect on my ability to understand and stay in a conversation,” said Mr. Prouty of Santa Rosa, California. “My wife may not agree.”

He said he wasn’t ready for hearing aids yet, and he felt that even less after discovering the devices would cost up to $8,400 for a pair and services. Mr Prouty welcomed the new policy and said he hoped it would boost the kind of consumer electronics that had revolutionized phones and watches.

“I’m looking forward to this,” he said.

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