Nearly five years after it was urged to make affordable hearing aids available over the counter, the FDA is taking a big step toward that goal. In a plan released Tuesday, the agency says it will create a new category of hearing aids that will be made available online and over the counter without a prescription and without a visit to a doctor or audiologist for a hearing exam. The FDA hopes this will increase competition, bringing down prices as new companies enter the market, though some existing manufacturers have expressed safety concerns, per the Washington Post.
Health and Human Services Secretary Xavier Becerra says the move "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." About 15% of US adults have difficulty hearing. But only about 15% of those who can benefit from a hearing aid use one, according to the FDA. That's partly because they’re so expensive, costing more than $5,000 per pair on average, per the Post.
While diagnostic hearing tests are generally covered by Medicare, hearing aids themselves are not, the AP reports, noting companies have said they can produce cheaper versions for $50 to $500. The President's Council of Advisors on Science and Technology recommended the FDA create a new category of "basic" hearing aids under President Obama in 2015. In 2017, President Trump approved a 2020 deadline that was missed. President Biden then instituted a November deadline this past summer. Public comments will be accepted before the proposal is finalized. (More FDA stories.)
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