August 21, 2017

Over-the-Counter Hearing Aid Legislation Signed into Law

Washington, DC - United States Senator Elizabeth Warren (D-Mass.) applauded the enactment of the bipartisan Over-the-Counter (OTC) Hearing Aid Act, which President Trump signed into law on Friday as part of the Food and Drug Administration (FDA) Reauthorization Act of 2017. The legislation was originally introduced by Senators Warren, Chuck Grassley (R-Iowa), Maggie Hassan (D-N.H.), Johnny Isakson (R-Ga.), Susan Collins (R-Maine) and Claire McCaskill (D-Mo.), along with Representatives Joe Kennedy III (D-Mass.) and Marsha Blackburn (R-Tenn.) in the House.

"This law will make a life changing difference for millions of Americans who experience hearing loss but can't access the hearing aid technology they need because of high costs and excessive regulations," said Senator Warren. "By passing this legislation and making some hearing aids available over the counter, we will increase competition, spur innovation, and bring down prices. I'm grateful to my colleagues - Democrats and Republicans - for joining me in this effort."

The OTC hearing aid legislation will make certain types of hearing aids available over the counter to Americans with mild to moderate hearing impairment. It also requires the FDA to write regulations 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, providing consumers the option of an FDA-regulated device at lower cost.

The Over-the-Counter Hearing Aid Act of 2017 received endorsements from leading organizations representing seniors, consumers and hearing health professionals, including the AARP, the Gerontological Society of America, the Hearing Loss Association of America, Consumers Union, the National Committee to Preserve Social Security & Medicare, the Center for Medicare Advocacy, the American Federation of Teachers, the Consumer Technology Association, the Leadership Council of Aging Organizations, the Niskanen Institute, R St. Institute, and the Academy of Doctors of Audiology.

Approximately 48 million Americans experience age-related hearing loss, including two-thirds of adults between the ages of 70 to 79. Yet only a small share of Americans with hearing loss - around 14 percent - use hearing aids, primarily due to their high cost. Hearing aids are not covered by Medicare or most private insurance plans, and out-of-pocket costs for a single hearing aid average $2,400 - far out of reach for many consumers.

The bill text is available here. A fact sheet about the bill is available here.