A long-awaited Food and Drug Administration proposal would allow millions of consumers to buy over-the-counter hearing aids in stores or online without a prescription or medical exam.

More than four years after Congress ordered the agency to allow over-the-counter hearing aids, it took the first step Tuesday to broaden access to more accessible and affordable devices for millions of patients with mild to moderate hearing loss. The agency’s proposal would create a new category of over-the-counter hearing aids and supersede state-level regulations that require patients to go through physicians or audiologists to get prescriptions and fittings for them.

Hearing aids cost an average more than $5,000 per pair, are not typically covered by traditional Medicare or other insurers, while advocates argue that over-the-counter models could be a fraction of that cost.

“Reducing health care costs for everyone in America is a top priority,” said Health and Human Services Secretary Xavier Becerra said in a statement on Tuesday. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”

Although 15 percent of adults in the United States report having some trouble hearing, according to the National Institute on Deafness and Other Communication Disorders, only about 1 in 5 use hearing aids. Cost and stigma associated with the medical devices stand in the way of some patients’ access.

“More than 30 million people suffer from some sort of hearing loss and hearing is so vital to what we do, your ability to communicate with others is a huge part of your quality of life,” said Vinay Rathi, a physician at Massachusetts Eye and Ear. “We’re really denying people that sort of basic right, which is the ability to communicate with others, because of issues related to cost and access to audiologists.”

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The FDA said on Tuesday that its new rule aims to spark innovation and increase competition by lowering barriers for new companies to enter the market while simultaneously regulating the new category of over-the-counter hearing aids to ensure the devices are safe and effective.

“Over the years, our number one call, email [and] letter is from people who can’t afford hearing aids, or they don’t have access to an audiologist or hearing aid specialist,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “Now, not all of those people would benefit from an over-the-counter product. We know that. But . . . this is going to help those people who might be able to benefit.”

Some opposition to over-the-counter sales from existing manufacturers have raised safety concerns. Companies like Starkey, one of the five major hearing aid manufacturers, have claimed that many patients’ hearing loss would best be treated by a physician.

The proposal follows more than five years of federal efforts to remove obstacles standing between patients and over-the-counter hearing aids. In 2015, the President’s Council of Advisors on Science and Technology under Barack Obama recommended the FDA create a new category of “basic” hearing aids that could be purchased without a prescription or a doctor’s visit. Two years later, former president Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, which gave the FDA three years to enact the new rules.

The FDA missed that 2020 deadline, but President Biden renewed pressure in July when he signed an executive order that set a November deadline for a new proposed rule from the federal agency.

Tuesday’s proposed rule will go through a comment period before it can be finalized.

“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 in a statement Tuesday. “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.”