FDA Proposes Rule on Over-the-Counter Hearing Aids

The U.S. Food and Drug Administration (FDA) this week unveiled a proposed rule intended to improve access to and reduce the costs of hearing aid technology for Americans. The federal agency proposes to establish a new category of over-the-counter (OTC) hearing aids, allowing hearing aids in this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.

According to the FDA, the proposed rule is designed to help increase competition in the market while ensuring the safety and effectiveness of OTC and prescription hearing aids. The proposed rule has been published in the Federal Register for public comment which closes in early 2022.

Additional information is available here.