TUESDAY, Aug. 16, 2022 (HealthDay News) — Affordable over-the-counter hearing aids will bring relief to millions of Americans suffering from hearing loss by mid-October, under a landmark proposal just announced by the U.S. Food and Drug Administration.

The final rule announced Tuesday creates 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, people with 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 close to 30 million U.S. adults 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 over-the-counter category established in the new rule applies to hearing aids intended for people aged 18 years or older who have mild-to-moderate hearing impairment. Other types of hearing aids — including those for children or people with severe hearing problems — will remain prescription devices.

The FDA received more than 1,000 public comments on the proposed rule when it was first issued on Oct. 20, 2021. The final rule incorporates several changes suggested in those comments, including the following: lowering maximum sound output to reduce the risk for hearing damage from overamplification; limiting how far the devices can be inserted in the ear canal to prevent potential injury; requiring that all over-the-counter hearing aids have a user-adjustable volume control; and simplifying language used in device labeling so the consumer can understand it.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Robert M. Califf, M.D., said in a statement. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

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