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A pair of senators is prodding the FDA to issue a final rule to allow a new category of hearing aids to be sold over the counter without a medical exam or audiologist fitting.
Why it matters: The change could give some of the estimated 38 million Americans with hearing loss more affordable choices and allow consumer electronics companies to enter the market.
Driving the news: Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) introduced legislation Friday to order a timetable for a final rule.
- The agency last October began outlining technical requirements for OTC hearing aids but it offers no timeline for when consumers could see them hit the market.
Context: Congress asked the agency in 2017 to explore broadened access by August 2020, but the agency missed the deadline due to the pandemic.
- Hearing aids cost thousands of dollars. Insurance coverage is limited and Medicare won't cover them. The stigma of hearing loss has also prevented millions from using them.
- Congressional Democrats proposed expanding Medicare coverage to hearing services at a cost of $35 billion over a decade as part of the sweeping social spending bill that stalled in the Senate.