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

The Food and Drug Administration today decided to make hearing aids available over-the-counter and without a prescription for adults, a long-held request from consumers frustrated by expensive exams and devices.

As early as mid-October, people with mild to moderate hearing loss will be able to buy hearing aids online and in retail outlets without having to visit a doctor to get a prescription.

The FDA cited studies that estimated about 30 million Americans have hearing loss, but only about a fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, into a broader field with less expensive and perhaps more innovative designs. Current hearing aid costs, which typically include visits to an audiologist, range from about $1,400 at Costco to about $4,700 elsewhere.

“This could fundamentally change the technology,” said Nicholas Reed, an audiologist in the Johns Hopkins Bloomberg School of Public Health’s Department of Epidemiology. “We don’t know what these companies could come up with. We can literally see new ways of how hearing aids work and what they look like.”

The FDA’s final rule will go into effect in 60 days. Industry officials say device makers are broadly ready to bring new products to market, although some may need time to update labeling and packaging or typically comply with technical details.

dr Robert Califf, the FDA commissioner, tweeted Tuesday that the rule addresses a “critical public health issue” affecting millions.

“The establishment of this new regulatory category will give people with a perceived mild to moderate hearing loss convenient access to a range of safe, effective and affordable hearing aids from their local store or online,” he 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 that are not covered by Medicare. There’s also a stigma – like appearing “old” – that comes with use.

Adults’ appreciation of the importance of sharp hearing is skewed, too: A recent survey found that people aged 50 to 80 are twice as likely to plan to take their pet to the vet in the coming year than to check their hearing allow.

“It breaks my heart a bit,” said Sarah Sydlowski, associate chief improvement officer 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 healthcare system is making sure people understand that hearing is incredibly important. It deserves your attention, it deserves your action.”

The change has been underway for years. In 2016, a National Academies report published a proposal for the FDA to allow over-the-counter hearing aids for adults with mild to moderate hearing loss. The following year, Senators Chuck Grassley, an Iowa Republican, and Elizabeth Warren, a Massachusetts Democrat, introduced a bill that allowed the agency to make the change signed into law.

The process of finalizing regulations has been slow to move forward since then, with some conflict over details such as: B. how the federal regulation would interact with state laws on hearing aid return or warranty policies, and how much the devices should amplify the sound.

President Biden issued an executive order last July calling for more competition in the economy, including requiring the release of the rule “to encourage the widespread availability of inexpensive hearing aids.”

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

“We welcome the measures to improve access to care for those with difficulties and encourage them to seek a professional” to guide their options and the adjustment process, said Kate Carr, president of the trade group. Other organizations raised concerns 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 had released a joint report accusing the “dominant hearing aid” manufacturers of engaging in “astroturf lobbying” efforts by inundating the FDA with repeated comments, leading the agency to a new generation of hearing aids that are “less effective at protecting manufacturers’ existing market share and maintaining their competitive advantage.”

The logic is simple: the less effective an OTC hearing aid is, the more likely consumers will be forced to abandon those options and instead opt for more expensive, prescription devices sold by the manufacturers that dominate this industry.” Senators’ investigation report said.

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