The U.S. Food & Drug Administration (FDA) released a letter sent to hearing aid manufacturers to emphasize that the OTC hearing aid category does not yet exist. The letter details the statutory mandate from the FDA Reauthorization Act of 2017 (FDARA) to establish a category for OTC hearing aids and the process. This process includes the FDA publishing proposed regulations by August 2020, to consider public comments, and to publish the final regulations within 180 days of the close of the comment period. The statute also stipulates that state or local law cannot pre-empt or differ from the regulations that the FDA will establish.
Individuals who are aware of current marketing efforts for OTC hearing aids should report such activities to the Federal Trade Commission’s Bureau of Consumer Protection and to the FDA (see contacts below). We also encourage members to copy us on related communications.