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 October 20, 2021, the FDA released Proposed rules for Over the Counter Hearing Aids. It is expected that new regulations will be published in 2022, at which time OTC hearing aids are expected to become available to the public.
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: