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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 with hearing loss from purchasing them. Health experts say that untreated hearing loss can lead to cognitive decline and depression in older adults.

Under the new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October without having to see a doctor for a prescription.

The FDA 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. Current costs for hearing aids, which include visits with an audiologist, range from about $1,400. at costco for about $4,700 elsewhere.

“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 at a press briefing on Tuesday. “It’s a big world problem where I think American ingenuity can make a big difference.”

The White House hailed the move as a signature achievement for President Biden, who is expected to sign the Inflation Reduction Act on Tuesday. The change eliminates the requirement to see an audiologist for a hearing screening and fitting, a process rarely covered by insurance.

Federal officials saved $2,800 on a pair of hearing aids. Brian Deese, director of the White House National Economic Council, said 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.

Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older adults. However, barriers to receiving hearing aid include costs not covered by Medicare. There is also the stigma of looking “old” that comes with use.

It is also uncertain to assess the importance of acute hearing for adults: Last request 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.”

The movement enlisted some of the country’s audiologists, professionals who guide people through the process of choosing the best hearing aid, adjusting settings and achieving the right fit. 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 to go away,” said Barbara Kelley, executive director of the Hearing Loss Association of America, which represents audiologists and consumers. “The over-the-counter rule opens up a great new way for adults with mild to moderate hearing loss to take that step sooner than later. That’s what really excites us.”

Change has been going on for years. In 2016, the FDA’s proposal to approve over-the-counter hearing aids for adults with mild to moderate hearing loss came before the National Academies. report. 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. signed the law.

The process of finalizing the rules has moved slowly since then, with some conflict over details such as how the federal rule interacts with state laws on hearing aid returns or warranty policies and how loud the devices can be.

President Biden issued an executive order last July calling for greater competition in the economy, including a call to promulgate a rule to “encourage the widespread use of low-cost hearing aids.”

That rule came out a public comment period followed in the fall. The Hearing Industry Association, an industry group, submitted a 45-page document comment letter After the original law was passed, the FDA alerted the FDA in 2018 about 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 with disabilities 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 make devices that allow users to hear loud sounds.

Senators Warren and Grassley were released 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 becomes, 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.

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