Bipartisan group urges FDA to act fast in approving over-the-counter hearing aids

Folks looking for bipartisanship in Washington should look no further than over-the-counter hearing aids.

A group led by Sens. Charles E. Grassley, Iowa Republican, and Elizabeth Warren, Massachusetts Democrat, urged the Food and Drug Administration on Wednesday to act swiftly in finalizing a regulation that will clear the way for Americans to find hearing aids in stores without a medical exam or fitting by a specialist.

It is a move that President Biden is pushing in a bid to increase competition in the hearing-aid market and cut costs for nearly 40 million Americans with hearing loss.

The comment period on a proposed regulation to create a new category of aids that can be sold directly in stores or online expired in mid-January. Senators ranging from Bernard Sanders, the progressive champion from Vermont, to Rand Paul, the libertarian from Kentucky, want regulators to issue a final regulation as fast as possible.

“With the public comment period now closed, we write to urge the FDA to finalize the rule without delay and in a manner that is consistent with congressional intent,” the lawmakers wrote to acting FDA Commissioner Janet Woodcock.

They said the final regulation is needed to implement a bipartisan 2017 law signed by then-President Donald Trump.  The final regulation will take effect 60 days after it is issued.

“By introducing more competition into the hearing aid market, the law, once properly implemented, will provide consumers with more options at a price they can afford,” the senators wrote.

The senators told the FDA to avoid watering down the regulations. They want to maintain the maximum sound pressure level identified in the proposed rule and ensure that federal regulations preempt state ones in the sale of over-the-counter hearing aids, so consumers don’t face a patchwork of rules.

Democratic Sens. Patrick Leahy of Vermont, Maggie Hassan of New Hampshire, Chris Van Hollen of Maryland and Republican Sens. Marsha Blackburn of Tennessee, Rick Scott of Florida, Lindsey Graham of South Carolina and Kevin Cramer of North Dakota are also on board.

The government estimates 38 million Americans suffer from hearing loss, yet only one in five persons who could benefit from hearing aids use them, primarily because of cost. The White House says people seeking hearing aids face an average cost of $5,000 for aids and they want to get that down to hundreds of dollars instead.

Older Americans are particularly impacted by hearing loss, with nearly one in three people between the ages of 65 and 75 and about half of adults 75 reporting difficulty.