FDA clears way for over-the-counter hearing aids

FDA clears way for over-the-counter hearing aids
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The Food and Drug Administration has decided to allow over-the-counter hearing aids to be sold to adults without a prescription, a longtime desire of consumers frustrated by expensive tests and devices.

The high cost of hearing aids, which are not covered by basic Medicare, 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 FDA’s new rules, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October without needing to see a doctor for testing to get a prescription.

The organization cites research estimating that about 30 million Americans experience hearing loss, but only one-fifth of them receive help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less expensive, and perhaps, more innovative designs. Costs for hearing aids, which include a visit to an audiologist, start at about $1,400. At Costco per Roughly $4,700 Or more.

“This could fundamentally change the technology,” says 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 can come up with. We can literally see new ways hearing aids work, what they look like.”

FDA’s final rule takes effect in 60 days. Industry representatives say device makers are largely ready to launch new products, although it may take time to update some labeling and packaging or comply with the technical details of regulations.

Dr. Robert Califf, FDA commissioner, said the move was intended to “unleash the power of American industry” in ways that could have global impact.

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

Hearing aid replacement eliminates the need to visit an audiologist for a hearing test and fitting, a procedure often not covered by insurance. Federal officials estimate a savings of $2,800 per pair of hearing aids. Brian Deese, White House director of the National Economic Council, said making the change is a “top priority” for the president.

“This is going to make a real concrete difference in the lives of millions of Americans,” Mr. Diez said.

Whether that will make a difference at the voting booth remains to be seen, said Jonathan Oberlander, a health policy professor at the University of North Carolina. He called the FDA’s move a sort of “consolation prize” in the wake of Democrats’ failed efforts to expand Basic Medicare to cover vision, teeth and hearing. On the contrary, though, some hearing aids should be on store shelves when voting begins

Associated with hearing loss Dementia, isolation and other health problems in older adults. Yet barriers to getting hearing aids include costs not covered by Medicare. There’s also the stigma — like looking “old” — that comes with use.

April Schramm, 45, of Bremerton, Wash., has wanted hearing aids for years, but was unable to get them covered by her insurance. He said he lost some of his hearing during a training deployment to Iraq nearly a decade ago. But his hearing loss did not test to a level that would qualify him for coverage.

“I don’t have to have a prescription for it,” Ms. Schramm said, “which means I can buy them myself and that’s great.”

Widespread perception is off-kilter for the importance of acute hearing for adults: A recent survey It found that people aged 50 to 80 were twice as likely to plan to take their pet to the vet in the next year than to have their hearing tested.

“It breaks my heart a little bit,” said Sarah Siedlowski, associate chief improvement officer at 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 health care 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 houses some of the nation’s audiologists, professionals who guide people through the process of choosing the best hearing aids, adjusting settings and achieving the right fit. The new move eliminates the long-standing need for consumers to start the process of getting hearing aids with them. But some see opportunities in the profession.

“The hearing health care professional is not going away,” Barbara Kelly, executive director of the Hearing Loss Association of America, told a consumer group. “The over-the-counter regimen opens up a huge new avenue for adults with mild to moderate hearing loss to take this step sooner. And we’re really excited about that.”

The change has been trickling down for years. In 2016, the FDA published a proposal to approve over-the-counter hearing aids for adults with mild to moderate hearing loss. Report By the National Academies of Sciences, Engineering, and Medicine. The following year, Senator Chuck Grassley, Republican of Iowa, and Elizabeth Warren, Democrat of Massachusetts, introduced a bill to enable the agency to make the change. Congress approved the legislation and President Trump Signed into law.

The finalization rules have moved slowly since then, with some conflict over details, such as how federal rules will interact with state laws on hearing aid return or warranty policies and how much the devices should amplify sound.

Mr. Biden last July issued an executive order calling for greater competition in the economy, calling on the FDA to take steps to “promote the widespread availability of low-cost hearing aids.”

That’s the rule is issued Fall 2021, followed by a public comment period. The Hearing Industries Association, an industry group, submitted the 45-page submission Comment letter FDA warns of companies entering the market in 2018, after the initial legislation was passed, selling hearing aids that are “inefficient, of poor quality and in some cases dangerous.” The organization has given detailed advice on how to avoid a repeat situation.

“We applaud the move to increase access to care for those with disabilities and encourage them to seek out a professional to help them navigate the options and fitting process,” said Kate Carr, president of the trade group. Other organizations have expressed concern that the FDA will create a safety issue by allowing new hearing aid manufacturers to create devices that allow users to hear loud sounds.

Senators Warren and Grassley were released A joint report “Powerful hearing aid” manufacturers are accused of engaging in “astroturf lobbying” efforts, with repeated comments to the FDA pushing the agency toward new generations of hearing aids that “will be less effective, protecting manufacturers’ existing market share and locking in” their competitive advantage. .”

The logic is simple: The less effective an OTC hearing aid is, the more consumers will be forced to forego these options and instead opt for the more expensive, prescription devices that dominate this line of business,” the senators’ investigative report said.

The FDA reviewed more than 1,000 comments submitted about the rule and made a handful of changes in the final version released Tuesday. These include reducing the maximum sound output of the device and modifying the ear canal insertion depth limit. The regulations also require that hearing aids have a user-controlled volume control and simplified wording on the product label.

John Pruitt, 65, said Tuesday he will be watching changes in the hearing aid field carefully. He says he recently had a test and discovered he has some hearing loss.

“I don’t think it’s had a huge impact on my ability to understand and hold a conversation,” said Mr. Prouty, of Santa Rosa, Calif. “My wife might agree.”

He said he wasn’t ready for hearing aids and felt even less so a pair of devices and service would cost up to $8,400. Mr Prouty welcomed the new policy, saying he hoped it would spur consumer electronic advances that have revolutionized phones and watches.

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

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