FDA finalizes rule to let Americans buy hearing aids without prescription

Aug. 16 (UPI) -- Federal regulators on Tuesday finalized a rule that will allow Americans to buy hearing aids over the counter, without a prescription -- a move that could save consumers millions of dollars in health costs.

The Food and Drug Administration issued the final rule to improve access to hearing aids, which was part of an executive order from President Joe Biden about a year ago.

The rule creates a new category for over-the-counter hearing aids and allows Americans with mild or moderate hearing impairments to buy the devices directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment.

"As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country," Biden said in a statement Tuesday.

"This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and well-being."

Congress passed bipartisan legislation a few years ago that required the FDA to create an over-the-counter hearing aids category, but that measure was never fully implemented.

"Reducing health care costs in America has been a priority of mine since day one and this rule is expected to help us achieve quality, affordable healthcare access for millions of Americans in need," Health and Human Services Secretary Xavier Becerra said in a statement.

"[This] represents a significant milestone in making hearing aids more cost-effective and accessible."

FDA Commissioner Dr. Robert Califf said the new rule will make it more convenient for millions of Americans with hearing disabilities -- many of whom live on lower incomes -- to receive the much-needed hearing aids.

"Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions," Califf said in a statement.