FDA approves over-the-counter sale of hearing aids for adults

WASHINGTON, DC. — On Tuesday, the Food and Drug Administration approved making hearing aids available over the counter and without needing a prescription, medical exam or adjustment from an audiologist.

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The FDA said the new ruling helps better the Biden-Harris administrations goal to increase access to high-quality health care and lower health care costs for Americans.

According to the FDA, almost 30 million American experience hearing loss, but only one-fifth of people with hearing problems uses the device correctly.

Many hearing aids can be expensive, with each device priced between $2,000 to $4,000.


“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 health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

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The hearing aids will be available online and over the counter as soon as mid-October, when the rule takes effect.

The new over-the-counter decision won’t apply to hearing devices for people with severe hearing loss, as those devices will remain prescription only.