Over the Counter Hearing Aids

The FDA Reauthorization Act of 2017 directed the FDA to develop regulations that would make Over-the-Counter (OTC) hearing aids available to the public by 2020. This process was delayed due to the COVID-19 pandemic, but on August 16, 2022, the FDA released the final rule creating a new regulatory class of over-the-counter hearing aids which will go into effect on October 17, 2022.

On January 19, 2022, following a recommendation from the Board's Advisory Commitee on Fitting and Dispensing Hearing Aids, and to provide guidance to the public and consumers, the Board adopted the following Joint Statement on Consumer-Administered Hearing Tests and Direct-to-Consumer Hearing Aid Sales: