Hearing aids can be expensive and hard to get. FDA rule would open access to millions of Americans.

·4 min read

Millions of American with mild to moderate hearing loss would be able to buy hearing aids at stores or online without a doctor's referral under a Food and Drug Administration proposal to broaden access to these widely used devices.

The FDA's proposed rule, released Tuesday, aims to encourage competition and lower costs of hearing aids that can run more than $2,500 and aren't covered by Medicare or many private insurers. The proposed rule would allow hearing aids to be sold in stores or online without an exam or fitting by a specialist and could potentially lower costs if competition materializes, regulators say.

For millions of Americans who suffer hearing loss, "safe, effective and high quality hearing aids are way too often out of their reach because of the price tag," said Health and Human Services Secretary Xavier Becerra. “We open the door to an easier process, a more affordable process, for people to have access to good quality hearing aids."

The FDA said about 37.5 million adults report some trouble hearing, but only about 1 in 5 people with hearing loss use a hearing aid. Aging, exposure to loud noises, medical conditions and other factors contribute to hearing loss. Hearing aids can help make speech and sounds louder and allow people with hearing loss to better communicate. The proposed rule would override state regulations and allow consumers greater control by eliminating the need for professional fittings, officials said.

“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.

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The proposed rule would not extend to children or adults with more severe types of hearing loss. People should seek medical care if they have ear deformities or symptoms such as discomfort or bleeding, officials said.

The proposed rule comes four years after Congress passed the Over-the-Counter Hearing Aid Act, directing the FDA to authorize the sale of over-the-counter hearing aids. In July, President Joe Biden’s executive order called for the FDA to issue a proposed rule within 120 days to allow over-the-counter sales of the product.

Still, consumers likely won't see any new products under the FDA's new category before next year. The public will have 90 days to comment on the proposed rule before the federal agency writes new regulations for the devices. Then the FDA will take an additional 60 days to implement the new regulations, officials said.

The FDA will still monitor safety and effectiveness of the hearing aids and will collect consumer feedback on products sold on the market. Manufacturers of existing hearing aids will have 180 days to ensure the products meet the new regulations. Companies that plan to introduce new products will be expected to meet the agency's criteria on safety and effectiveness, officials said.

Attorneys general in Georgia, Louisiana, Missouri, North Carolina, Ohio and South Carolina have issued warnings about companies marketing claims on hearing aids already being sold directly to consumers. FDA officials said any companies selling hearing aids over the counter or online are violating FDA regulations.

Becerra, California's former attorney general, said the agency plans to make the regulations consumer friendly to ensure people buying hearing aids consumers "don’t get confused and end up being hoodwinked or driven down a rabbit hole" when they try to get a refund.

He said the FDA also will be careful to make sure consumers aren't confused by existing products sold on the market. "What we don’t want is for people to be sold by those who would claim they now have FDA approval and there is some kind of FDA Good Housekeeping Seal of Approval to what they do," Becerra said.

Hearing-loss doctors say consumers who suspect hearing loss should get a diagnostic exam to understand the type and degree of hearing loss, said Stephanie Czuhajewski, executive director of the Academy of Doctors of Audiology.

Still, the audiologists' group support the concept of selling hearing aids directly to consumers. Consumers who don't treat their hearing loss are at increased risk for unfavorable health outcomes such as falls or cognitive decline.

"We have much more understanding now of undertreated or nontreated hearing loss," Czuhajewski said. "We do want to make sure people who want to pursue over the counter hearing aids and who suspect they have mild-to-moderate hearing loss are able to do so as one of their options."

Hearing aid manufacturers such as Minnesota-based Starkey said they will solicit feedback from industry leaders, medical professionals and patients about the proposed rule.

“It is imperative for the public to understand that hearing health care professionals are an essential resource, as they determine not only which products are right for each patient’s unique hearing loss, but also to prevent more damage to their hearing," said Starkey CEO Brandon Saliwich.

Ken Alltucker is on Twitter as @kalltucker or can be emailed at alltuck@usatoday.com.

This article originally appeared on USA TODAY: FDA rule to allow Americans to buy hearing aids without prescription

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