FDA moves to offer hearing aids over the counter

The Food and Drug Administration took steps Tuesday to allow over-the-counter sales of hearing aids so people can buy them without a medical exam or fitting by a specialist, a move President Biden is pushing in a bid to cut costs for nearly 40 million Americans with hearing loss.

Regulators proposed a rule that would establish a new category of aids that can be sold directly in stores or online. The idea is to spur competition for the roughly 15% of U.S. adults who report they have trouble hearing but face an average cost of $5,000 for aids.

“It’s consumer choice that will drive what’s out there in the market for people to get,” Health and Human Services Secretary Xavier Becerra said.

The secretary said the new category of store-based hearing aids will be useful for people with mild to moderate hearing loss. People with an acute problem will still need to see a specialist.

Officials said the regulation lays out specific situations, such as deformities in the ear or pain and discomfort, that suggest when people should seek specialized help instead of heading straight to the store to fix mild hearing loss.

The move implements the Over-the-Counter Hearing Aid Act, which was passed by Congress as part of an FDA reauthorization bill during the Trump administration in 2017.

Mr. Biden earlier this year demanded a timeline for action as part of a sweeper executive order designed to kickstart competition in a variety of industries.

A bipartisan duo that championed the 2017 law applauded the FDA’s move as a major step, given that 1 in 3 Americans aged 65 to 75 and half of those over 75 have trouble hearing, but hearing devices often are not covered by private insurance or Medicare.

“We’ve just cleared a major regulatory hurdle for over-the-counter hearing aids,” said Sens. Charles E. Grassley, Iowa Republican, and Elizabeth Warren, Massachusetts Democrat. “Soon, millions of people with mild to moderate hearing loss will finally have lower-cost hearing aid options — and more options mean more competition in the market, further driving down the cost for consumers. This is terrific news.”

The FDA’s rule will be open to public comment for 90 days, after which the agency will issue a final rule that takes effect 60 days later.

The administration said its rule will lower “barriers to entry” for new manufacturers of hearing aids. By selling hearing aids in regular stores instead of doctor’s offices or specialty outlets, consumers will see more choices and lower costs, it said.

“We’re hopeful that the rules will be finalized next year and, with increased competition, expect hearing aids to cost hundreds instead of thousands of dollars,” said White House press secretary Jen Psaki.

Regulators said the rule will apply to hearing aids, which are FDA-regulated medical devices that compensate for hearing loss by filtering for sounds the person wants to hear, and not to personal sound amplification products — or PSAPs — that amplify all sounds in an environment.

Officials said 37.5 million adults report hearing loss, which is often caused by aging or exposure to loud noises.

“Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” acting FDA Commissioner Janet Woodcock said. “The FDA’s proposed rule represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options.”