Loud And Clear Need In US For OTC Hearing Aids For Mild To Moderate Loss, Congress Tells FDA
Hearing loss is one of the most common conditions affecting older US consumers, with nearly one in three between the ages of 65 and 74 having difficulty hearing, Sens. Warren and Grassley and Resp. Kennedy and Carter note in urging FDA to finalize regulations allowing certain hearing aids to be sold OTC.
You may also be interested in...
One of 72 items in an executive order by the president on promoting competition in the economy notes that 14% of the around 48m US consumers with hearing loss use hearing aids because, on average, they cost more than $5,000 per pair, costs often not covered by health insurance.
President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.
A House Health subcommittee wants to attach a quartet of medtech bills to a fast-moving user fee package in Congress. The bills, which got a hearing before the Energy and Commerce Committee Health Subcommittee May 2, would streamline inspections and third-party certifications of device exports, refine FDA regulations on over-the-counter hearing aids, make third-party device equipment servicers register and file complaints with the agency, and clarify FDA product-center jurisdiction for contract agency-dependent imaging equipment.