WASHINGTON — The Food and Drug Administration on Tuesday took a major step toward bringing down the cost of hearing aids by making them available over the counter.
The freedom to buy hearing aids without a fitting or test by a specialist is likely to make them cheaper and the market more competitive. The cost of hearing aids can run into the thousands. They often are not covered by insurance companies or traditional Medicare, the federal health program for people over 65, although private Medicare Advantage plans sometimes cover them.
Hearing loss can exacerbate isolation and loneliness in older adults, with serious implications for their quality of life and health. Because of the price, a small fraction of adults with hearing loss use them, and uptake is lower among low-income seniors and people of color.
The FDA called the rule a “landmark proposal.” Once finalized, the rule would create a new category of over-the-counter hearing aids targeting people with mild to moderate hearing loss who are less likely to need the help of an audiologist. There will be a 90-day comment period, and the rule faces a 60-day implementation deadline after that.
Health and Human Services Secretary Xavier Becerra said the regulation is personal to him, as his mother had been hoodwinked and struggled to get her money back from an unscrupulous manufacturer. Unregulated personal amplification devices have proliferated because of the high cost of hearing aids.
“For some 30 million Americans who suffer from hearing loss, safe, effective and high-quality hearing aids are way too often out of their reach due to the high price tag,” Becerra said on a press call with reporters Tuesday. “I say that not just as the secretary of HHS but also the son of a mother who has had to go through multiple hearing aids and who is out several hundred dollars trying to get it back from one of these manufacturers.”
The move is in keeping with a wide-ranging anti-monopoly executive order that President Joe Biden signed in July. The White House instructed the FDA to move within 120 days on over-the-counter hearing aid regulation required under a 2017 law. The agency had blown past that deadline in the law, which called on the regulators to act within three years, amid a barrage of challenges related to the pandemic in 2020.
The rule could face fierce resistance from hearing aid manufacturers and professional societies representing audiologists. The FDA also said it would begin cracking down on hearing aids and other sound amplification devices not under FDA compliance.
Sens. Charles E. Grassley, R-Iowa, and Elizabeth Warren, D-Mass., whose bill proposing the change was incorporated into a larger FDA law, praised the announcement. The senators directed a letter calling for more urgent action to the FDA last week.
“We’ve just cleared a major regulatory hurdle for over-the-counter hearing aids,” they said in a joint statement. “This is terrific news.”
The rule also comes amid a legislative debate on whether to cover traditional hearing aids under Medicare. Congressional Democrats are attempting to cram a range of health care priorities into a social policy budget bill while also paring the bill’s price tag to as low as $1.5 trillion over a decade.
Progressives are pushing to add hearing, dental and vision coverage to the program, but many industry observers see the provision as the most endangered. The House bill would also exclude coverage of over-the-counter hearing aids.
