Adults with perceived mild to moderate hearing impairment will be able to buy hearing aids directly from stores, pharmacies and online retailers — no prescription or doctor's appointment required — as soon as mid-October.

That's thanks to a final rule issued by the U.S. Food and Drug Administration on Tuesday and set to take effect in two months, following years of campaigning by lawmakers and advocates. It creates a new category of over-the-counter hearing aids, which the Biden administration says will make the devices more accessible and affordable for millions of Americans.

The new rule applies only to certain air-conduction hearing aids for people ages 18 and older who experience mild to moderate hearing impairment, meaning those that are intended for pediatric use or severe hearing impairment will remain prescription devices. It also does not apply to "personal sound amplification products," consumer products that help people with normal hearing amplify sounds.

Hearing loss can complicate communication and contribute to social isolation, and researchers have also linked it to walking problems, falls, dementia and depression. Some 30 million U.S. adults could benefit from hearing aid use, according to the FDA. And yet, only about 14% of Americans with hearing loss actually use them.

The rule will lower costs and expand access

Until now, the high cost of hearing aids and exams — which are not covered by basic Medicare and often not covered by insurance — has been prohibitive for many people. The devices alone typically range from $1,000 to $6,000 per ear, and consumers must spend additional time and money getting examined and fitted by a specialist (even though, the White House says, experts say medical evaluation is not necessary).

The Biden administration estimates the new rule will lower the cost of hearing aids by hundreds or even thousands of dollars. FDA Commissioner Robert Califf told reporters on a press call that the FDA is working with manufacturers to ensure the over-the-counter devices are of "good quality" and meet the agency's performance criteria.

It may also make the market more competitive

The administration is also touting the move as one that will reduce red tape while promoting innovation and competition in a highly concentrated marketplace.

An investigative report released by Sens. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., in June found that the top five hearing aid manufacturers control more than 90% of the market.

Grassley and Warren have been leading the campaign for over-the-counter hearing aids since 2017, when they introduced the bipartisan Over-the-Counter Hearing Aid Act.

Congress passed that proposal at the time, but the Trump administration FDA didn't issue the rules that would actually allow for those devices to be sold directly to consumers. It's being implemented now because of the July 2021 "Executive Order on Promoting Competition in the American Economy," in which Biden called on the FDA to take action on over-the-counter hearing aids within 120 days (among a variety of other provisions).

The rule was years in the making

The FDA issued the proposed rule in October, and made several changes to the final version after reviewing more than 1,000 public comments.

Grassley and Warren's report found that hearing aid manufacturers and their allies backed "astroturf campaigns" to distort public perception around the proposed rule, launching form letter-writing campaigns that accounted for nearly 40% of all publicly available comments.

The senators applauded the FDA's announcement, saying in a statement that they "pressed the FDA to take action every step of the way — holding both Republican and Democratic administrations accountable — and fought back against entrenched special interests."

If you're thinking about buying over-the-counter hearing aids yourself, check out these tips from the Hearing Loss Association of America.