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

WASHINGTON DC – 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.) Thursday, August 3, 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 Sen. 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.”

“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 Sen. 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 Over-the-Counter Hearing Aid Act of 2017 The Over-the-Counter Hearing Aid Act of 2017 implements recommendations from PCAST and the National Academies to help the millions of Americans affected by hearing impairment.

The Act:

• Makes certain types of hearing aids – those intended to be used by adults to compensate for perceived mild to moderate hearing impairment – available over the counter.

• Removes an unnecessary and burdensome requirement that consumers obtain a medical evaluation or sign a waiver of that examination in order to obtain an OTC hearing aid.

• Requires the FDA to issue regulations containing safety and labeling requirements for this new category of OTC hearing aids.

• Maintains existing safety, labeling, and manufacturing protections and applies them to OTC devices in order to ensure that OTC hearing aids are held to the same high standards as other medical devices.

• Requires the FDA to update its draft guidance on Personal Sound Amplification Products (PSAPs), consumer electronics products that may use similar technology to hearing aids, but are intended for use by individuals with normal hearing.

 

Framingham Source Editor Susan Petroni

Susan Petroni Framingham Source Editor Email: editor@FraminghamSource.com Phone: 508-315-7176

Leave a Reply