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Bipartisan Over-the-Counter Hearing Aid Legislation To Become Law

Legislation Included in FDA Reauthorization Act Could Impact Millions of Americans with Hearing Loss

Aug 3, 2017

Washington, D.C. - U.S. Senators Elizabeth Warren (D-Mass.), Chuck Grassley (R-Iowa), Maggie Hassan (D-N.H.), Johnny Isakson (R-Ga.), Susan Collins (R-Maine) and Claire McCaskill (D-Mo.), and Representatives Joe Kennedy III (D-Mass.) and Marsha Blackburn (R-Tenn.) today applauded final passage of the Over-the-Counter (OTC) Hearing Aid Act as part of the Food and Drug Administration (FDA) Reauthorization Act. The legislation passed the House Energy and Commerce Committee by a unanimous, bipartisan vote, and passed the full House of Representatives without objection in July. The legislation was voted out of the Senate Health, Education, Labor & Pensions Committee on a bipartisan vote, and passed the Senate today 94-1.

The 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.

"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."

"A lot of people are looking forward to the enactment of this provision," Senator Grassley said. "Consumers are interested in new hearing aid products to improve their quality of life at an affordable price. The more products available, the more consumers will be able to find something they can afford that works for them."

"As more and more Granite Staters and Americans are squeezed by rising health care costs, this bipartisan bill is an important step forward in our efforts to bring real cost savings to older Americans who experience hearing loss, while encouraging innovation in the market," said Senator Hassan. "I am pleased that the Senate took an important step forward to making affordable, over-the-counter hearing aids a reality, and I will continue working across the aisle to strengthen the health and financial well-being of all hard-working Americans."

"In addition to funding the FDA's important work, this legislation will help millions of Americans with mild to moderate hearing loss by improving access to hearing aids, driving down costs and increasing competition," said Senator Isakson.

"Hearing aids allow Americans who experience hearing loss to communicate with friends, family, coworkers, and others as well as participate fully in society. I recently chaired an Aging Committee hearing on social isolation among seniors, which revealed that hearing loss, if left untreated, may contribute to loneliness, increasing the risk of serious mental and physical health outcomes." said Senator Collins. "By making some types of hearing aids available over the counter, this commonsense legislation will help increase access to and lower the cost of these products for the consumers who need them."

"Expensive, inaccessible hearing aids not only deny millions of Americans hearing loss relief, they leave our neighbors facing isolation, anxiety and even memory loss," said Congressman Kennedy. "By sparking innovation and competition in this industry, this bill will improve the lives of our constituents in their communities, businesses and homes. With bipartisan passage of this bill through Congress, we have moved closer to a country where mild to moderate hearing loss is no longer a debilitating diagnosis."

"I am very pleased to see the FDA reauthorization pass in the Senate and even more pleased it contained the Over-the-Counter Hearing Aid measure I sponsored in the House," Congressman Blackburn said. This is a true win for the millions of Americans struggling with hearing loss and the costs associated with it. Making hearing aids more accessible and affordable is a commonsense measure and I am glad to see bipartisan support in both chambers come together to pass this for the American people."

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.

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