FDA to Authorize Non-Prescription Hearing Aids

In a milestone development, the U.S. Food and Drug Administration (FDA) will soon authorize non-prescription hearing aids, potentially giving millions of hearing-impaired people access to affordable hearing devices.

In a Final Rule published in the Federal Register in mid-August, the FDA is establishing a regulatory category applicable to over-the-counter (OTC) hearing aids. The Final Rule also modifies existing labeling requirements and conditions for sale applicable to hearing aids to pave the way for certain models to be sold without a prescription from an authorized medical professional.

The FDA says it is in the process of finalizing general controls for OTC hearing aids consistent with the Federal Food, Drug, and Cosmetic Act as amended.

According to the FDA, hearing loss affects an estimated 30 million people in the U.S., impacting their ability to effectively communicate with others and compromising their overall health and safety. Yet, only about 20% of those affected by hearing impairments leverage current hearing aid technology to alleviate this disability, with the high cost of prescription hearing aids one of the main obstacles.

Read the FDA’s Final Rule on OTC hearing aids as published in the Federal Register.

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