Senators Grassley and Warren Urge FDA to Initiate Overdue Rulemaking for OTC Hearing Aids
Senate Finance Committee Chairman Chuck Grassley (R-IA) and Senator Elizabeth Warren (D-MA), a member of the Senate Health, Education, Labor, and Pensions Committee, sent a letter to the U.S. Food and Drug Administration (FDA) to initiate its overdue rules for over-the-counter (OTC) hearing aids without further delay.
Warren and Grassley’s Over-the-Counter Hearing Aid Act, which was signed into law in 2017, required the FDA to issue these proposed regulations no later than August 18, 2020.
The letter states that “the impact of the novel coronavirus on the agency’s priorities and workload cannot be overstated, and we appreciate the FDA’s continued efforts to respond to this global crisis that has profoundly affected so many Americans. However, despite the pandemic, hearing loss continues to be a problem for millions of Americans, and we believe that the FDA must also make issuing the OTC hearing aid regulations a priority, consistent with the law.”
This latest letter follows a December 2019 letter in which they also urged the FDA to finalize rules for OTC hearing aids.