Congress passes OTC hearing aid legislation

Congress passes OTC hearing aid legislation

Source: drugstorenews.com

AUGUST 7, 2017 | BY MICHAEL JOHNSEN

WASHINGTON — A new class of OTC hearing aids is one presidential signature away from becoming reality. The U.S Senate on Thursday passed the Over-the-Counter Hearing Aid Act as part of the Food and Drug Administration Reauthorization Act on a vote of 94-1.

“Thanks to bipartisan support on this issue, millions of Americans will improve their quality of life with little impact on their pocketbook,” stated Gary Shapiro, president and CEO, Consumer Technology Association. “Until now, nearly half of online U.S. adults – 98 million Americans – with hearing loss have been unable to access adequate hearing assistance due to prohibitively high hearing aid costs as well as the inconvenience and financial burden of doctors appointments. This legislation will create a new class of over-the-counter hearing aids costing roughly one-tenth the price of traditional hearing aids, making it easier for those with mild-to-moderate hearing loss to afford the hearing assistance that they need.”

“This legislation will create a new class of over-the-counter hearing aids costing roughly one-tenth the price of traditional hearing aids.”

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.

The bipartisan legislation was supported by Sens. 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 Reps. Joe Kennedy III, D-Mass., and Marsha Blackburn, R-Tenn.

“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,” Warren said. “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.”

“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.” added 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.”

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% – 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.

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