Federal regulators may soon settle a years-long debate over cheaper, over-the-counter hearing aids — an issue that has divided Minnesota companies with a stake in the industry.

On one side are the disruptors: medical technology firms that want to do for hearing aids what Warby Parker did for eyeglasses. On the other side are the industry veterans: established hearing aid companies that worry lax regulation could hurt consumers by not ensuring proper care and diagnosis.

More than 38 million Americans — or 15% of adults — report having some trouble hearing.

Standard hearing aids are typically expensive and not covered by health insurance. These steep costs have prevented many people who could benefit from getting hearing aids. A 2017 survey from the Hearing Health Foundation found that only 14% of Americans with hearing loss use hearing aids.

Over-the-counter (OTC) hearing aids won't require a prescription and could be available on retail store shelves and online before the end of the year.

In 2017, Congress directed the U.S. Food and Drug Administration to create a category and regulatory structure for OTC hearing aids within three years, but the process has met several delays. The Biden administration tried to jumpstart it by including OTC hearing aids as part of a sweeping executive order in July 2021 encouraging increased competition across a host of U.S. industries.

OTC hearing aids are intended for adults with mild to moderate hearing loss, not for people with more severe hearing problems.

Dr. Melisa Oblander, director of audiology for M Health Fairview, supports the concept of OTC hearing aids.

"I think it will help increase patient access," she said.

But, she said, many consumers are already confused by an array of cheap devices, known as amplifiers, that they mistake for hearing aids.

"Some people think there already are over-the-counter hearing aids," Oblander said. "I think things will get more refined over time. The technology is really going to open up once the FDA labeling gets figured out."

Arden Hills-based Intricon is hoping to be a significant player in the OTC hearing aid market.

"In this over-the-counter market I think you're going to see hearing aids priced somewhere between $400 and $600 apiece," chief executive Scott Longval said. The current average cost for a single hearing aid is about $2,000, but some can cost as much as $10,000 for a pair.

Longval said Intricon has focused on assembling the necessary technology, software and firmware, something "almost 10 years in the making." He said the company wants to help develop hearing aid options that are low cost and high quality. Intricon will produce the hearing aids, but they will be distributed by other companies that put their brands on them.

Some elected officials and industry players have raised consumer concerns about the debut of OTC hearing aids.

"People should still seek a professional diagnosis, treatment, and fitting in order to have the best outcome possible to address their unique hearing loss," Rep. Betty McCollum, D-St. Paul, said in a statement to the Star Tribune. She signed a letter to the FDA earlier this year outlining concerns.

Longval said he is well aware of the industry resistance: "The large manufacturers have pushed back heavily."

The FDA's proposed rule drew more than 1,100 comments, including a 23-page letter from Eden Prairie-based Starkey, a major industry player, outlining a range of concerns.

Starkey recommended several changes to the FDA's proposed rule, asking regulators to "require validated labeling to ensure potential users can self-diagnose hearing loss" and "establish a federal level of consumer protection."

The company has set up a website, ListenCarefully.org, where it outlines its concerns.

"At Starkey, we support increased access to hearing health care," said CEO Brandon Sawalich, in a video on the website. "But as we increase access, we must protect patient safety and satisfaction above all else."

It's not yet clear whether health insurers will help pay any of the costs for OTC hearing aids. Under federal statute, Medicare does not cover hearing aids or exams for fitting hearing aids.

Medicare Advantage plans that are offered by private companies can cover vision, hearing and wellness costs that aren't covered by Medicare. A spokesman for Minnetonka-based Medica said that the insurer had not yet made any decisions about coverage for OTC hearing aids.