Proposal would create a category of hearing aids that could be sold directly to consumers, without medical exam or audiologist fitting
TUESDAY, Oct. 19, 2021 (HealthDay News) — Affordable over-the-counter hearing aids could soon bring relief to millions of Americans suffering from hearing loss, under a landmark proposal announced Tuesday by the U.S. Food and Drug Administration.
The proposal would create a category of hearing aids that could be sold directly to consumers, without either a medical exam or a fitting by an audiologist. Until now, patients suffering from hearing loss have typically had to pay thousands of dollars for a device that could only be adjusted by a professional audiologist.
That has been a barrier that left many without the hearing help they need. While roughly 15 percent of Americans report some trouble with their hearing, the FDA estimates that only one in five people who could benefit from a hearing aid actually use one.
The proposal is the culmination of efforts dating back to 2017, when Congress passed a law requiring the FDA to establish a category of over-the-counter hearing aids. The FDA missed its August 2020 deadline to propose those new rules, blaming the COVID-19 pandemic for the delay. But in July, President Joe Biden issued an executive order that set a November deadline for the FDA to finish its work on the new hearing aid rule.
The over-the-counter hearing aids produced under the proposed rule would be intended for adults with mild-to-moderate hearing loss, the FDA said. Hearing aids for severe hearing loss or for children younger than 18 years would still require a prescription and a professional fitting.
To ensure patient safety, the proposal also sets a maximum volume limit for over-the-counter hearing aids, which is intended to prevent injuries from overamplification. The proposal also includes performance and design requirements for the devices, including limits on distortion control, self-generated noise, processing speed, range of reproducible frequencies, and insertion depth of the device. Lastly, the proposal also would set labeling requirements for over-the-counter hearing aids.
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