Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) introduced S.9, the Over the Counter Hearing Aid Act of 2016, on December 1. This bill directs the U.S. Food and Drug Administration to create an over-the-counter hearing aid classification for adults with mild to moderate hearing loss that may include tests for self-assessment of hearing loss, and finalize guidance on personal sound amplifiers. The bill also calls for the FDA to establish requirements that ensure the safety and efficacy of the OTC device, and delineate the circumstances under which an OTC device may be sold without professional involvement. IHS met with the sponsors’ staffs to express our strong concerns with the bill, which is not expected to see final action in 2016. IHS will be in touch with members in the new year with calls to action.