No Prescription Necessary: Hearing Aids Soon Will Be OTC

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Woman showing her hearing aid to friends
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Listen up! Hearing aids will become more accessible, and possibly more affordable, this fall.

A newly finalized federal regulation “establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist,” the U.S. Food and Drug Administration announced Tuesday.

Last year, President Joe Biden ordered the start of this process, noting that the average hearing aid price tag of more than $5,000 had led to just 14% of Americans with hearing loss using hearing aids.

Nearly 30 million adults in the U.S. could benefit from hearing aids, and the new regulation is intended to foster competition and bring down prices, the FDA says.

The rule takes effect on Oct. 17, 2022, so OTC hearing aids could become available in stores starting as early as mid-October.

However, manufacturers of hearing aids sold prior to Oct. 17 have up to six months thereafter to comply with the regulation.

Can’t wait that long? Take a look at our story “How to Save Hundreds of Dollars on Hearing Aids.”

What is a federal regulation anyway?

Federal regulations, also referred to as rules, are created by federal agencies, boards and commissions — such as the U.S. Food and Drug Administration, in this case.

Regulations explain how federal agencies should carry out the laws created by Congress. Regulations themselves also have the force and effect of law.

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