No Prescription? No Problem: FDA Draft Rule Gives Green Light To OTC Hearing Aids
Executive Summary
The US FDA’s proposed reg, released on 19 October, aims to get more hearing aids into the ears of those who need them by allowing the devices to be purchased over the counter.
You may also be interested in...
A Year Of Extraordinary Health Challenges: CDRH Annual Report
In its 2021 annual report, the US FDA’s Center for Devices and Radiological Health outlines what it sees as list of accomplishments in a year director Jeff Shuren says was perhaps the busiest in the center’s history.
Senators, State AGs Differ On Whether Further Federal Regulation Needed For OTC Hearing Aids
Sens. Warren and Grassley say federal regulation is needed to ensure consumers in all states benefit from OTC hearing aids. State AGs, on the other hand, have asked the FDA to “define preemption terms in a way that recognizes the important role state and local entities play in protecting consumers.”
Comments On US FDA OTC Hearing Aid Proposed Rule Urge Clarification On Recommended Users
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.