FDA issues final rule for OTC hearing aid sales

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WASHINGTON — The FDA released its final rule for the marketing of over-the-counter hearing aids on Tuesday, with Xavier Becerra, secretary of the Department of Health and Human Services, calling it an “exceptional day” for Americans with hearing loss. , and for their families.

The final rule “establishes a new category of over-the-counter (OTC) hearing aids, allowing consumers 18 and older with mild to moderate hearing loss to purchase hearing aids directly from stores or retailers in line without the need for a medical exam, prescription or adjustment by an audiologist,” the FDA said in a press release. “The rule is designed to provide reasonable assurance of the safety and effectiveness of over-the-counter hearing aids, while promoting innovation and competition in the hearing aid technology market.”

Jeff Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, gave more details in a phone call with reporters about what was included in the final rule, which defines air conduction hearing aids sold over-the-counter like those “worn inside the ear or over the ear with an in-ear component, and amplify sound in the ear canal.” Hearing aids for patients with severe hearing loss or for users under 18 will remain prescription devices, he added.

“To ensure patient safety as well as effectiveness, the FDA has set a maximum output amount, or sound volume limit, for over-the-counter hearing aids that is intended to prevent over-amplification of sound to prevent hearing loss. additional, while at the same time allowing for adequate amplification to ensure the products’ effectiveness,” Shuren said. “The rule also includes certain device performance and design requirements, such as limits on distortion, noise, delay and the range of frequencies that the device will reproduce. Additionally, the rule includes requirements to limit the depth of insertion of the device — how far the hearing aid can enter the ear canal — to minimize the risk of injury.”

Hearing loss is a widespread problem, noted FDA Commissioner Robert Califf, MD. “About 30 million Americans ages 18 and older report hearing problems,” he said. “And despite the high prevalence and public health impact of hearing loss, only around one in five people who could benefit from a hearing aid currently use one…The rule will allow consumers to have a more great control over their hearing aid purchasing decisions in stores nationwide or online, without a professional hearing test, fitting or prescription.” Patients could see the over-the-counter hearing aids available “as early as mid-October”, he added.

From an economics perspective, “the requirement to see a doctor or hearing specialist was an example of what economists call a ‘barrier to entry’ – it was regulation that prevented further ‘companies or innovators to enter the market,’ said Brian Deese, JD, director of the National Economic Council at the White House. “This not only limited who could enter the market and be distributed, but the bundling of hearing aids with reviews also reduced competition by making it harder for consumers to shop around to find the best deal, which eroded the competitive pressure to charge less. This is an example of where regulation itself was impeding innovation and consumer choice.”

Now that hearing aids are available over the counter, “we expect competition to drive costs down,” he continued. “In fact, the FDA estimates that this rule will save the consumer about $1,400 per individual hearing aid, or more than $2,800 per pair.”

MedPage today asked Califf if there are any concerns that patients are not getting the medically best hearing aid if they buy it without medical advice. “There are [still] going to be the option for people to go to the prescription space and see an audiologist,” he replied. “We have a shortage of audiologists, and I think they will be very busy with people who try the consumer approach and find they need additional help, or may have medical issues that [require] they are monitored by a doctor while they work with their hearing aids. So none of these options are removed. It just opens up that consumer option for people who have a relatively simple hearing loss issue that can be helped by the over-the-counter product.”

Becerra praised the new rule, adding that he himself was “the son of one of those consumers in this country who had to buy all kinds of pairs of hearing aids and is still trying to recoup several hundred dollars unreimbursed for hearing aids that didn’t work… Today’s FDA action should help make hearing aids not only more accessible, but truly more affordable for the dozens of million people with mild to moderate hearing loss.”

In addition to the marketing rule, the agency issued final guidance on “regulatory requirements for hearing aids and personal sound enhancement products,” which it said in the press release is intended to “clarify the differences between hearing aids, which are medical devices, and personal sound amplification products, which are not regulated as medical devices, and which help people with normal hearing amplify sounds in certain environments. “

  • Joyce Frieden oversees MedPage Today’s coverage in Washington, including stories about Congress, the White House, the Supreme Court, professional health associations and federal agencies. She has 35 years of experience in health policy. Follow

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