WASHINGTON DC (December 6, 2019) — Senate Finance Committee Chairman Charles "Chuck" Grassley (R-IA) and Senator Elizabeth Warren (D-MA) are today pressing the Food and Drug Administration (FDA) over its lack of action on writing rules to allow the sale of over-the-counter hearing aids.
The Over-the-Counter Hearing-Aid Act, a bill led by Sens Grassley and Warren, was signed into law in 2017. That law allows the FDA to promulgate regulations categorizing certain hearing aids as “over-the-counter,” and sets an August 2020 deadline for such rules. By allowing hearing-aids to be sold over-the-counter, there is more competition in the market and that will result in much lower prices. Last October, the FDA announced that writing those rules would be a priority for the agency, but has shown no sign of progress since.
“…although hearing-aids are considered prescription products, they are not generally covered by health insurance or Medicare and can cost thousands of dollars. For seniors or those on limited budgets, at these prices, hearing-aids may not be obtainable,” the senators wrote.
In a letter today to the Acting FDA Commissioner, the senators requested a status update on the rules and an expected date for their finalization.
Full text of the letter from Sens Grassley and Warren follows or can be found HERE.
