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 US 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% 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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