Delayed Release of Proposed Over-the-Counter Hearing Aid Regulations
Three years ago the Over-the-Counter (OTC) Hearing Aid Act was signed into law. Under the terms of that law, proposed regulations for this new class of hearing aid were supposed to be released on or before August 18, 2020.
Although the FDA has not issued an official statement, the Academy has learned through various sources that the release of these proposed regulations are now expected at the end of the year.
This delay is most likely due to the Food and Drug Administration’s continuing focus on addressing the COVID-19 pandemic.
This is a fluid situation and the Academy is monitoring the situation very closely. These regulations when released are not final, and the Academy will have ample time to review and provide comment and recommendations.