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FDA paves the way for the sale of non-prescription hearing aids


Health

“This is going to make a really tangible difference in the lives of millions of Americans.”

Kim M. Smith, leader of the Utah Deaf Hospital Rights movement and president of the Utah Association of the Deaf, brushes her hair out of her hearing aid, Jan. 20, 2020, at Alta View Hospital in Sandy, Utah. Isaac Hale/The Daily Herald via AP, file

The Food and Drug Administration on Tuesday decided to allow over-the-counter and non-prescription hearing aids to be sold to adults, 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 hearing-impaired Americans from purchasing these devices. Health experts say untreated hearing loss can contribute to cognitive decline and depression in older people.

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

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The FDA 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. Current costs for hearing aids, which typically include visits to an audiologist, range from around $1,400 at Costco to around $4,700 elsewhere.

“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 day-to-day communication, social interaction, and the overall health and quality of life of millions of Americans,” Califf said during a Tuesday press briefing. “It’s a huge global problem where I think American ingenuity can make a huge difference.”

The White House also hailed the move as a milestone achievement for President Joe Biden, who was expected to sign the Cut Inflation Act into law on Tuesday. The change eliminates the need to see an audiologist for a hearing test and fitting, a process rarely covered by insurance.

Federal officials estimated the savings in the cost of a pair of hearing aids at $2,800. 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,” Deese said.

Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older adults. 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.

Appreciation of the importance of acute hearing for adults is also off-kilter: a recent survey found that people between the ages of 50 and 80 were twice as likely to plan to take their pet to the vet during of the coming year than to have their hearing checked.

“It breaks my heart a bit,” said Sarah Sydlowski, associate director of improvement at the Cleveland Clinic 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 decision 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 drug rule opens up a huge new avenue for adults with mild to moderate hearing loss to take this step as soon as possible. And that’s what really excites us.

The change has been felt for years. In 2016, an FDA proposal to approve over-the-counter hearing aids for adults with mild to moderate hearing loss was published in a National Academies report. The following year, the senses. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., introduced a bill allowing the agency to make the change that had been signed into law.

The process of finalizing the regulations has evolved 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 amplification of sound by devices.

Biden issued an executive order in July 2021 calling for greater competition in the economy, which included a call for the rule to be released “to promote the wide availability of low-cost hearing aids.”

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

“We applaud the 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 manufacture devices that allow users to hear loud sounds.

Warren and Grassley had released 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 manufacturers’ existing market share and securing 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 instead opt 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.

This article originally appeared in The New York Times.



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