No Prescription? No Problem: US FDA Draft Rule Gives Green Light To OTC Hearing Aids
Executive Summary
FDA’s proposed rule aims to get more hearing aids into the ears of consumers who need them by allowing OTC sales of the devices. Proposal follows a a July executive order by President Biden directing HHS to issue proposed rules for OTC hearing aids within 120 days.
You may also be interested in...
US FDA Proposed Rule Needs Clarifications On Who Should Use OTC Hearing Aids – Comments
More than 1,000 comments were submitted by professional and civic organizations, trade groups and consumers FDA proposed rule on allowing OTC sales of hearing aids intended for consumers with mild to moderate hearing loss.
Senators Emphasize Federal Pre-emption In US OTC Hearing Aid Rule, State Attorneys General Disagree
Warren and Grassley say legislation instructing FDA to establish OTC sales of some hearing aids stated a federal regulation is needed to ensure consumers in all states benefit from the change. State AGs, on the other hand, ask FDA to “define preemption terms in a way that recognizes the important role state and local entities play in protecting consumers.”
Facilitating More OTC Switches In US Graduates To Regulatory Plan On FDA’s Unified Agenda
For first time rules for novel switches and OTC hearings aids are parts of “significant regulatory actions” in agency’s plans. Information is added in Unified Agenda items explaining likely benefits and costs from the changes.