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FDA paves the way for over-the-counter hearing aids

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The Food and Drug Administration on Tuesday decided to allow hearing aids to be sold to adults without a prescription, a wish long sought by consumers frustrated with expensive exams and devices.

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

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

The agency cited studies estimating that about 30 million Americans suffer from hearing loss, but only about a fifth of them receive help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, into a larger field with cheaper and possibly more innovative designs. Hearing aid costs, which typically include visits to an audiologist, range from approximately $1,400 at Costco at approximately $4,700 or more.

“It 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 might offer. 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 officials say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or comply with technical details. of the rule.

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

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

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

“This is going to make a very real difference in the lives of millions of Americans, Mr. Deese said.

Whether that will make a difference in the voting booth remains to be seen, said Jonathan Oberlander, professor of health policy at the University of North Carolina. He called the FDA’s decision a “consolation prize,” given Democrats’ failed efforts to expand basic health insurance to vision, dental and hearing. The upside, however, is that some of the hearing aids should be on store shelves by the time voting begins.

Hearing loss is associated with dementia, isolation and other health problems in the elderly. Yet barriers to getting a hearing aid include costs that are not covered by Medicare. There’s also the stigma – like appearing “old” – that comes with use.



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April Shrum, 45, of Bremerton, Washington, has been wanting to get hearing aids for years but hasn’t been able to get them covered by her insurance. She said she lost her hearing while shooting guns while training to deploy to Iraq about a decade ago. But her hearing loss was never tested to a level that qualified her for coverage.

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

A broader appreciation of the importance of fine hearing for adults is offset: A recent study found that people between the ages of 50 and 80 were twice as likely to plan to take their pet to the vet in the next year than to have their hearing checked.

“It breaks my heart a bit,” said Sarah Sydlowski, associate director of improvement 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 extremely important. It deserves their attention, it deserves their action.

The over-the-counter change has upset some of the nation’s audiologists, the professionals who guide people through the process of choosing the best hearing aid, adjusting settings and getting the right fit. The new ruling eliminates the long-standing requirement that consumers begin the process of obtaining a hearing aid with them. But some in the profession see it as an opportunity.

“The hearing health professional isn’t going away,” said Barbara Kelley, executive director of the Hearing Loss Association of America, which represents audiologists and consumers. “The over-the-counter ruler opens up a huge new avenue for adults with mild to moderate hearing loss to take that step sooner rather than later. And that’s what really excites us. »

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

Finalizing the regulations has moved slowly since then, with some disputes over details, like how the federal rule would interact with state laws on hearing aid returns or warranty policies and the amount of sound amplification. by devices.

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

This rule was published in the fall of 2021, followed by a public comment period. The Hearing Industries Association, an industry group, submitted a 45-page report comment letter warning the FDA of companies that entered the market in 2018, after the original law was passed, selling “ineffective, poor quality, and in some cases unsafe” hearing aids. The organization offered detailed advice on how to avoid a repeat scenario.

“We applaud action to increase access to care for people who are struggling and encourage them to seek out a professional,” to help them navigate their options and the coping process, said Kate Carr, president of the trade group. Other organizations have raised concerns 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 freed a joint report accusing “dominant hearing aid manufacturers” of engaging in an “astroturf lobbying” effort by flooding the FDA with repetitive comments pointing the agency towards a new generation of hearing aids that would be “less effective, protecting the manufacturers’ existing market and locking in their competitive advantage.

The logic is simple: the less effective an over-the-counter hearing aid is, the more likely consumers are to be forced to abandon those options and opt instead for more expensive prescription devices sold by manufacturers who dominate this market. activity area. says the report.

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

John Prouty, 65, said on Tuesday he would closely monitor changes in the hearing aid field. He said he recently had a test and discovered he had suffered hearing loss.

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

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

“I can’t wait to be there,” he said.