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WASHINGTON -- The FDA on Tuesday released its for marketing of over-the-counter hearing aids, with the Xavier Becerra, secretary of the Department of Health and Human Services, calling it an "outstanding day" for Americans suffering from hearing loss, and for their families.

The final rule "establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers 18 years of age and older with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist," the FDA . "The rule is designed to provide a reasonable assurance of safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace."

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

"To ensure patient safety as well as effectiveness, the FDA set a maximum amount of output, or sound volume limit, for over-the-counter hearing aids that's intended to prevent overamplification of sound to avoid further hearing loss, while at the same time allowing for adequate amplification to assure effectiveness of the products," said Shuren. "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. In addition, the rule includes requirements to limit the insertion depth of the device -- how far the hearing aid can go into 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 aged 18 and older report some trouble with their hearing," he said. "And despite the high prevalence and public health impact of hearing loss, only about one out of five people who could benefit from a hearing aid are currently using one ... The rule will enable consumers to have greater control over their hearing aid purchasing decisions at stores nationwide or online, without a professional hearing test, fitting adjustment, or a prescription." Patients could see OTC hearing aids available "as early as mid-October," he added.

From an economic perspective, "the requirement to see a doctor or a hearing specialist was an example of what economists call a 'barrier to entry' -- it was a regulation that kept more companies or more innovators from entering the market," said Brian Deese, JD, director of the National Economic Council at the White House. "It not only limited who could enter the market and get distribution, but the bundling of hearing aids with exams also reduced competition by making it harder for consumers to comparison shop for the best deal, which eroded the competitive pressure to charge less. This is an example of where a regulation itself was getting in the way of innovation and consumer choice."

Now that hearing aids are going OTC, "we expect that competition will drive down costs," he continued. "In fact, the FDA estimates this rule will save the consumer on the order of about $1,400 per individual hearing aid, or over $2,800 per pair."

MedPage Today asked Califf whether there were concerns about patients not getting the best hearing aid from a medical standpoint if they are buying it without medical advice. "There is [still] going to be the option for people to go into the prescription space and see an audiologist," he responded. "We have a shortage of audiologists, and I think they'll be plenty busy with people who try the consumer approach and find that they need additional help, or may have medical problems that [require] they're under the care of a physician as they work with their hearing aid. So none of those options are taken away. This just opens up that consumer option for people that have a relatively simple hearing loss problem 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 has had to shop for all sorts of pairs of hearing aids and is still trying to recoup several hundred unreturned dollars for hearing aids that did not work ... Today's action by the FDA should help make hearing aids not only more accessible, but truly more affordable for those tens of millions of people who have been experiencing mild or moderate hearing loss."

In addition to the marketing rule, the agency issued on "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products," which it said in the press release aims 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."

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