The Food and Drug Administration started Tuesday to make hearing aids available to adults over the counter and without a prescription, a long-sought wish by consumers frustrated by expensive exams and devices.
From mid-October, people with mild to moderate hearing loss should be able to purchase hearing aids online and in stores, without having to go to a doctor for a medical examination to get a prescription.
The FDA cited studies that estimate that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could turn the market, which is dominated by a relatively small number of manufacturers, upside down and make it a broader field with less expensive and perhaps more innovative designs. Current costs for hearing aids, which usually include visits with an audiologist, range from about $1,400 at Costco to about $4,700 elsewhere.
“This could fundamentally change 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 are coming up with. 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 representatives say device makers are largely ready to launch new products, although some may need time to update labeling and packaging or comply with technical details as a rule.
dr. Robert Califf, the FDA Commissioner, tweeted Tuesday that the rule addresses a “critical public health problem” affecting millions.
“By introducing this new regulatory category, people with perceived mild to moderate hearing loss can easily access a range of safe, effective and affordable hearing aids at their convenience store or online,” he said.
Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older adults. But the barriers to getting hearing aid include costs not covered by Medicare. There is also stigma – like appearing “old” – that comes with the usage.
The appreciation for the importance of sharp hearing is also strange for adults: A recent study found that people aged 50 to 80 were twice as likely to take their pet to the vet in the next year than to have their hearing checked. .
“It kind of breaks my heart,” said Sarah Sydlowski, associate chief improvement officer of the Cleveland Clinic Head and Neck Institute and lead author of the study. “I think our biggest challenge as a profession and as a healthcare system is to make sure people understand that hearing is incredibly important. It deserves their attention, it deserves their action.”
The change has been going on for years. In 2016, a proposal for the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing loss appeared in a report from the National Academies. The following year, Senators Chuck Grassley, an Iowa Republican, and Elizabeth Warren, a Massachusetts Democrat, introduced a bill that would allow the agency to enact the amendment signed into law.
The process to finalize the regulation has been slow since then, with some conflict over details, such as how the federal rule would interact with state laws about hearing aid returns or warranty policies and how much the devices should amplify sound.
President Biden issued an executive order last July calling for more competition in the economy, including a call to publish the rule “to promote the wide availability of low-cost hearing aids.”
That rule came out in the fall, followed by a period of public comment. The Hearing Industries Association, an industry group, has submitted a 45-page comment letter warning the FDA of companies that entered the market in 2018, after the original law was passed, and sold hearing aids that were “ineffective, of poor quality, and in some cases, dangerous.” The organization gave detailed advice on how to avoid a recurrence scenario.
“We applaud the move to increase access to care for those with problems and encourage them to seek a professional,” said Kate Carr, president of the trade group. Other organizations expressed concern that the FDA would create a safety issue by allowing new hearing aid manufacturers to create devices that allow users to hear loud sounds.
Senators Warren and Grassley had released a joint report accusing the “dominant hearing aid makers” of engaging in an “astroturf lobby” by flooding the FDA with repeated comments that would send the agency to a new generation of hearing aids that are “less effective.” , protect manufacturers’ existing market share and maintain their competitive advantage.”
“The logic is simple: The less effective an OTC hearing aid is, the more likely consumers will be forced to forgo these options and instead opt for more expensive prescription devices sold by the manufacturers that power this industry. dominate,” the senators’ inquiry said. report said.
The FDA reviewed more than 1,000 submitted comments on the rule and made a handful of changes to the final version released Tuesday. They include lowering the maximum sound output of the devices and revising the limit for insertion depth into the ear canal. The rule also requires the hearing aids to have user-adjustable volume controls and simplified text on the product label.
