The U.S. Food and Drug Administration (FDA) announced a new proposal to ease access to hearing aids by reducing the barriers to acquiring them over the counter.

On Tuesday, the FDA issued the proposal in line with an executive order from President Joe Biden in July to make the devices more readily available for those in need of them. Secretary of Health and Human Services described the decision as progress in moving “one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people” who need a hearing aid. 

“Reducing health care costs for everyone in America is a top priority,” said Becerra.

“The FDA’s proposed rule represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options," said Acting FDA Commissioner Janet Woodcock. She added that the new proposal will "provide the public with greater control over their hearing aid purchasing decisions" at stores or online.

Once finalized, a new “over the counter” (OTC) category for hearing aids can be sold to customers without the usual medical exams or fittings by an audiologist. The agency says that this rule would help improve innovation increase competition by lowering the barriers to entry for new hearing aid manufacturers to then meet these needs.

The National Institute on Deafness and Other Communication Disorders (NIDCD) estimates that 37.5 million Americans age 18 and over report some trouble hearing.

The FDA’s new proposal includes updates to existing guidance that the agency says will bring consistency to devices OTC  category. It also includes regulations to set standards for labeling requirements in this new category, noise limits, as well as performance and design requirements. 

The FDA’s announcement was greeted with bipartisan support by members of Congress. 

Sen. Elizabeth Warren, D-Mass., called the decision "terrific news" because it would improve access to what she says are the nearly "40 million adults" who report hearing problems. Sen. Chuck Grassley, R-IA, said he was "pleased" with the move that will contribute to bringing an end to price gouging for these devices.

Both senators previously collaborated on crafting a bill in 2017 called the Over the Counter Hearing Aid Act that was signed into law by former President Donald Trump. Just last week, Warren and Grassley issued nearly identical statements that bemoaned the FDA's slow speed in issuing regulations that would finalize regulations under that law.