WASHINGTON, D.C. — 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.

Only a fifth of the approximately 40 million people with hearing loss have hearing aids, according to Bharat Ramamurti, deputy director of the White House’s National Economic Council.

“There are really concrete medical harms that we can be reducing by making hearing aids available over the counter,” he said in an interview, citing a connection between hearing loss and dementia.

Ramamurti said a more competitive marketplace for hearing aids will cut the average cost of a hearing aid from the thousands into the hundreds of dollars. That price slash is likely to save billions on the projected price tag of the proposed Medicare expansion.

In the current monopolized market, covering hearing aids for millions of seniors with Medicare would have cost $89 billion from 2020 to 2029, according to a December 2019 Congressional Budget Office estimate. But the CBO has not gamed out how much less it would cost in a more competitive marketplace unleashed by the rule.

Ramamurti emphasized that Biden’s executive order got FDA moving on the overdue policy.

“I think it’s fair to say the Biden administration is prioritizing the completion of these rules in a way that the prior administration did not,” Ramamurti said in an interview.

The rule applies to the air conduction technology typically used by the hearing impaired but not other sound amplification devices used more casually by hunters and bird-watchers.

Those cheaper personal sound amplification devices have grown in popularity and innovation as the hearing aid market has grown stagnant and inaccessible. But the FDA took action in 2013 to prevent personal sound amplification device makers from marketing themselves as hearing aids, even while hearing aids remained hard to access, according to Obama administration scientific advisers.

The FDA’s proposed rule will clarify the difference between the regulated medical devices and nonregulated personal amplification devices, FDA acting Commissioner Janet Woodcock told reporters.

Over-the-counter hearing aids will have to meet certain specifications, including a cap on the amount of amplification provided, which could limit the use of over-the-counter devices for more severe cases, when audiologists may need to be consulted.

“We know there is a risk of overamplification and noise-induced hearing loss if the amplification is too loud,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “We also tried to achieve a balance. … The hearing aid will still have enough power to amplify sound all the way up to people with moderate hearing loss.”

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