Innerscope Hearing Technologies Inc (INND)

[Yak]

“Release of Proposed Over-the-Counter Hearing Aid Regulations

The U.S. Food and Drug Administration (FDA) was originally set to release draft regulations on over-the-counter (OTC) hearing aids in August 2020 to implement the Over-the Counter-Hearing Aid Act of 2017.

The release of these regulations was delayed because of COVID-19. We anticipate the FDA will release OTC regulations in the first quarter of 2021. When released, the Academy will move swiftly and provide comments to the FDA to preserve patient safety, ensure device efficacy, and safeguard and advance the profession of audiology.

Watch for Academy news with more information when the FDA releases guidance.”