FDA allows over-the-counter sales of hearing aids without doctor exam or referral

Millions of Americans could have access this fall to less expensive hearing aids sold over the counter without a required doctor's exam and prescription.

A Food and Drug Administration rule unveiled Tuesday allows retail sales of hearing aids by mid-October for people with mild to moderate hearing loss. Regulators said the new rule should give millions of adults less expensive options and broaden access for those who can't afford hearing aids.

"Today, the FDA opens the door to quality, affordable hearing aids to consumers over the counter," Department of Health and Human Services Secretary Xavier Becerra said on a call with reporters Tuesday. "For many Americans who suffer from hearing loss, safe and effective and high-quality hearing aids have been unaffordable."

Nearly 30 million adults have 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 to better communicate.

The agency estimates the new class of devices would save consumers about $2,800 for a pair of hearing aids, officials said. Some hearing aids cost more than $5,000 between the price of the device and a professional fitting. Medicare covers a diagnostic test but does not pay for the device.

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

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf.  “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

The agency made changes to a proposed rule last October based on public comments from consumers, stakeholders and experts. The final rule requires retail hearing aids to lower maximum sound and to include user-adjustable volume control. The final rule also limits how deep the devices can be placed in the ear canal. Manufacturers must meet performance and device design requirements in order to sell the devices directly to consumers.

Califf said the agency evaluated safety concerns about sound output limits for the new class of hearing aids. Devices with high sound output levels could potentially jeopardize long-term hearing while devices without enough sound could be ineffective.

"We thought we hit the sweet spot on the output limit," Califf said.

The rule comes five years after Congress passed the Over-the-Counter Hearing Aid Act, directing the FDA to authorize the sale of over-the-counter hearing aids.

Nancy LeaMond, AARP executive vice president and chief advocacy and engagement officer, said expanding access to affordable aids could improve overall health and quality of life for those with hearing loss.

“For many Americans, the high cost of prescription hearing aids puts them out of reach, increasing their risk of isolation, depression and other health issues," LeaMond said.

While the new rule could provide affordable options for millions of people with hearing loss, some urged consumers to be careful.

The Hearing Industries Association, which represents major hearing aid manufacturers, suppliers and hearing health professionals, said hearing loss is unique for each person. Most people do not know if their condition is mild, moderate, or greater, caused by another medical issue or something as simple as ear wax, the group said.

"Our suggestion is really to first see a hearing professional and have a hearing test and have some solid information about the degree of hearing loss," said Kate Carr, president of the Hearing Industries Association.

A limited number of hearing aids are being sold directly to consumers now. Bose received FDA clearance in 2018 to sell hearing aids directly to consumers. The company discontinued its hearing aids this year and now partners with Lexie Hearing, which sells a device incorporating Bose's technology for $899.

Carr said consumers must understand a hearing aid's return policies and warranties when they purchase a product. Because over-the-counter hearing aids are not sold through a licensed medical professional, any consumer protections must be enforced under state and local laws.

In January, the National Association of Attorneys General urged the FDA to ensure states' authority to enforce their consumer protection laws for the sale of consumer hearing aids. A bipartisan coalition of 43 attorneys general noted the FDA's preliminary rule included language that "may unintentionally hinder or repeal" state consumer protection laws.

But FDA officials said states will have full authority to enforce consumer protection laws as long as such laws don't restrict or interfere with consumers' access to the new class of devices.

States can "enforce consumer protections for over-the-counter hearing aids," including laws that ensure reasonable warranty and return policies, said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

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

This article originally appeared on USA TODAY: Hearing aids to be available over the counter under new FDA rule