FDA clears the way for commonly sold hearing aids

FDA clears the way for commonly sold hearing aids
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The Food and Drug Administration decided Tuesday to allow over-the-counter hearing aids for adults, a long-sought desire by consumers frustrated by expensive exams and devices.

The high cost of hearing aids not covered by basic Medicare has deterred millions of Americans from purchasing the devices. Health experts say that untreated hearing loss can lead to cognitive decline and depression in older adults.

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

The agency cited studies that estimate that nearly 30 million Americans have hearing loss, but only one-fifth of them receive help. The changes could upend a market dominated by a relatively small number of manufacturers and turn it into a wider field with lower costs and perhaps more innovative designs. Costs for hearing aids, which include visits with an audiologist, range from about $1,400. At Costco tone about $4,700 or more

“This could fundamentally change the 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 can come up with. We can literally see how hearing aids work, how they look.

FDA’s final rule takes effect in 60 days. Industry representatives say device makers are mostly ready to release new products, although some may need time to update labeling and packaging or comply with regulatory specifications.

Dr. FDA Commissioner Robert Califf said the move was to “unleash the strength of American industry” in a way that could have a global impact.

“Hearing loss has a profound impact on everyday communication, social interaction, and the overall health and quality of life of millions of Americans,” said Dr. Califf said this during the briefing. “It’s a huge world problem that I think American ingenuity can make a big difference in.”

The White House hailed the move as a signature achievement for President Biden, who plans to sign the Inflation Reduction Act into law on Tuesday. That legislation includes other health measures, Such as drug cost caps for Medicare beneficiariesprobably popular with intermediate voters.

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

“This will make a real difference in the lives of millions of Americans,” he said. Deese said.

Jonathan Oberlander, a health policy professor at the University of North Carolina, remains to be seen whether that will make a difference in the voting booth. I called the FDA’s move a “consolation prize” of sorts, given the Democrats’ failed efforts to expand basic Medicare to cover vision, teeth and hearing. On a positive note for the party, some hearing aids should be on store shelves by the time voting begins.

Associated with hearing loss dementia, isolation and other health problems in the elderly. However, barriers to receiving hearing aid include costs not covered by Medicare. There’s also the stigma that comes with using it – like looking “old”.

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April Shrum, 45, of Bremerton, Washington, has been willing to buy hearing aids for years, but her insurance couldn’t cover them. He said he lost his ability to hear gunfire nearly a decade ago while training for a deployment to Iraq. But his hearing loss never progressed to a level that qualified him for coverage.

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

It is impossible to overestimate the importance of acute hearing for adults: A recent survey It found that people between the ages of 50 and 80 were twice as likely to plan to take their pets to the vet in the next year than to have their hearing checked.

“It breaks my heart a little bit,” said Sara Sydlowski, chief research assistant 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 making sure people understand that hearing is incredibly important. It deserves their attention, it deserves their action.”

Over-the-counter, some of the experts who guide people through the process of choosing the best hearing aid, adjusting settings, and achieving the right fit ranked the nation’s audiologists. The new move eliminates the longstanding requirement that consumers begin the process of purchasing dozens of hearing aids. But some professionals see an opportunity.

“The hearing health professional is not going away,” said Barbara Kelley, executive director of the Hearing Loss Association of America, which represents audiologists and consumers. “The over-the-counter regimen opens up a huge new way for adults with mild to moderate hearing loss to take that step sooner than later. That’s what we’re really excited about.”

Change has been going on for years. In 2016, a proposal was released to the FDA 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, Senators Chuck Grassley, Republican of Iowa, and Elizabeth Warren, Democrat of Massachusetts, introduced a bill that would allow the agency to make changes. Congress approved the law and President Trump signed the law.

The final rules have been moving slowly since then, with some conflict over details such as how the federal rule will interact with state laws on hearing aid returns or warranty policies and how loud the devices can be.

Mr. Last July, Biden issued an executive order calling for greater competition in the economy, which urged the FDA to act “to promote the widespread availability of low-cost hearing aids.”

That rule was released in the fall of 2021, followed by a public comment period. The Hearing Industry Association, an industry group, submitted a 45-page document comment letter After the original law was passed in 2018, the FDA issued a warning to companies that marketed hearing aids that were “ineffective, of poor quality, and in some cases dangerous.” The organization provided detailed advice to prevent a repeat scenario.

Kate Carr, president of the trade group, said: “We welcome the move to increase access to care for people in need and encourage them to seek out a specialist to help guide their choices and the matching process.” Other organizations expressed concern that the FDA would create a safety issue by allowing new hearing aid manufacturers to develop devices that allow users to hear loud sounds.

Senators Warren and Grassley were released in a joint report He accused the “dominant hearing aid” manufacturers of an “astroturf lobbying” effort by flooding the FDA with repeated comments that would make the agency “less effective, protect manufacturers’ existing market share, and shift their competitive advantage to the next generation of hearing aids.”

The logic is simple: The less effective an OTC hearing aid is, the more likely consumers will be forced to forgo those options and instead opt for more expensive, prescription devices sold by manufacturers that dominate the field,” the senators’ study reported.

The FDA reviewed more than 1,000 comments submitted on the rule and made several changes in the final version released Tuesday. These include reducing the maximum sound output of the devices and revising the ear canal insertion depth limit. The rule also requires hearing aids to have user-adjustable volume controls and simplified wording on the product label.

John Prouty, 65, of Santa Rosa, Calif., said he will be watching closely for changes in the hearing aid field. He said he was recently tested and discovered he had hearing loss.

“I don’t think it had a huge impact on my ability to understand and stay in a conversation,” she said. Prouty said. “My wife might not agree.”

He said he wasn’t ready for hearing aids and felt even less so after learning the devices would cost $8,400 a pair and service. Mr. Prouty welcomed the new policy, saying he hoped it would encourage consumer electronics development that revolutionized phones and watches.

“I’m looking forward to it,” he said.

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