Over-the-Counter Hearing Aids Could Be Available by October, FDA Announces
The FDA announced on Tuesday that access to hearing aids will be expanded.
Americans 18 years and older will be able to purchase over-the-counter hearing aids without a medical exam, prescription, or fitting adjustment by an audiologist as early as October.
The FDA’s decision offers more affordable and accessible healthcare.
About 30 million Americans experience some degree of hearing loss, and would benefit from the use of a hearing aid, according to the National Institute on Deafness and Other Communication Disorders. And as of now, hearing aids are only available via prescription and with a heavy price tag—but by October that could change. The U.S. Food and Drug Administration (FDA) ruled today to allow hearing aids to be sold over-the-counter (OTC).
This decision allows those with “perceived mild to moderate hearing impairment” to obtain hearing aids from in-person or online retail and drugstores “without the need for a medical exam, prescription, or a fitting adjustment by an audiologist,” according to the FDA. These over-the-counter hearing aids are expected to be available as early as October of this year.
This decision results from President Biden’s Executive Order which called upon the FDA to “to promote the wide availability of low-cost hearing aids,” in July of 2021.
“The rule is expected to lower the cost of hearing aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public,” the FDA explained in a press release. “It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace.”
Thousands of Americans supported the proposed ruling, including consumers, professionals, hearing aid manufacturers, members of congress, and more. This level of support helped influence the final FDA decision to expand access to hearing aid devices.
The decision will affect so many, in so many ways. “Expanding buying options is important because our ears can help foster work success and a happy social life as well as keep us safe,” explained Barbara Kelley, executive director of the Hearing Loss Association of America said in a previous interview with Prevention.
As of now the cost of over-the-counter hearing aids is unknown, but the move to OTC is expected to slash prices. Currently in the U.S., prescription hearing aids can range from $1,400 to almost $3,000 for a single hearing aid—that’s up to $6,000 a pair—according to Better Hearing. And that price doesn’t include the costs of seeing a specialist to prescribe the hearing aids in the first place.
The OTC options won’t be exactly like their prescription counterparts, though. “To assure the safety and effectiveness” of over-the-counter hearing aids, certain design elements of the devices will change, according to the FDA. These changes will include: “lowering the maximum sound output to reduce the risk of hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood.”
This awaited move by the FDA to make these auditory devices available without a medical test, prescription, or fitting will allow countless people with hearing impairments to get what they need, faster and cheaper. Now that’s music to our ears.
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