December 06, 2019

Senators Warren, Grassley Urge FDA to Issue Rules for Over-the-Counter Hearing Aids

The Warren-Grassley Over-the-Counter Hearing Aid Act was signed into law in 2017, requires FDA to set rules by August 2020

Washington, DC - United States Senators Elizabeth Warren (D-Mass.), member of the Senate Health, Education, Labor and Pensions Committee, and Chuck Grassley (R-Iowa), Chairman of the Senate Finance Committee, wrote to the Food and Drug Administration (FDA) on December 5th requesting information about the agency's progress writing rules to allow the sale of over-the-counter (OTC) hearing aids, as required by the Over-the-Counter Hearing Aid Act.
The Over-the-Counter Hearing Aid Act, a bipartisan bill led by Senators Warren and Grassley, was signed into law in 2017. The law allows certain types of hearing aids to be made available over the counter to Americans with mild to moderate hearing impairment. It also requires the FDA to write regulations by August 2020 ensuring that this new category of OTC hearing aids meets the same high standards for safety, consumer labeling, and manufacturing protections as all medical devices. These rules will provide consumers with the option to purchase an FDA-regulated hearing aid at lower cost.
"lthough 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.
Last October, the FDA announced that writing those rules would be a priority for the agency, but since then, has shown no sign of progress. In a letter to the Acting FDA Commissioner, the senators requested a status update on the rules and an expected date for their finalization.
Senator Warren continues to lead the fight in lowering costs for patients with hearing loss. In addition to passing the Over-the-Counter Hearing Aid Act, she has alsocalled on the Centers for Medicare and Medicaid Services Administrator Seema Verma to remove roadblocks that prevent Medicare beneficiaries with hearing loss from accessing audiology services. In July, she partnered with Senator Rand Paul (R-Ky.) to introduce bipartisan legislation, the Medicare Audiologist Access and Services Act of 2019.