FDA moves to allow hearing aids to be sold over the counter

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The FDA Oct. 19 proposed a rule that would allow some hearing aids to be sold over the counter, a move the agency says would boost accessibility and lower costs of the devices. 

The proposed rule would implement the Over-the-Counter Hearing Aid Act introduced by Sens. Elizabeth Warren, D-Mass., and Chuck Grassley, R-Iowa and signed into law in 2017. The law states that the FDA "must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids," according to NPR, though the agency has, until now, failed to take action.

It would allow hearing aids designed for adults with mild to moderate hearing loss to be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist. Children and adults with severe hearing loss would still need a prescription to obtain a hearing aid. 

"Reducing healthcare costs for everyone in America is a top priority," HHS Secretary Xavier Becerra said in a news release. "Today's move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss."

The FDA said 37.5 million adults in the U.S., or 15 percent of the adult population, have difficulty hearing. 

There is no clear timeline on when over-the-counter hearing aids may be available, as the proposed rule is up for 90 days of public comment.

Read the FDA's full news release here

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