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FDA Finalizes Rule To Make Hearing Aids Over-the-Counter It should take effect in 60 days.

By Gabrielle Bienasz

Opinions expressed by Entrepreneur contributors are their own.

On Tuesday, the FDA finalized a rule that will allow for hearing aids to be sold over-the-counter, theoretically cutting time and money from a multi-step, expensive process.

"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," Health and Human Services Secretary Xavier Becerra said in the FDA's release.

Why are hearing aids so expensive?

To get a hearing aid, you previously had to visit an audiologist to get your hearing evaluated and get them fitted, as well as obtain medical clearance from your doctor, according to Cleveland Clinic.

The actual devices, however, are not usually covered by insurance or Medicare and are sold by Audiologists, who usually charge $2,000 per hearing aid — so $4,000, roughly, for a pair, according to Forbes Health.

"The rule is expected to lower the cost of hearings aids," the FDA added in its statement. Over-the-counter aids could be available — and thus more accessible for many — in stores by mid-October, it added.

People who are over 18 and who have "perceived mild to moderate hearing loss," will be able to buy the devices over the counter, per the FDA.

Luis Medina, a pharmacist and owner of Baron II Drug & Surgical, a surgical supply store and pharmacy in Moonachie, New Jersey, told Entrepreneur he hopes to start selling hearing aids in his store because he often recommends them to customers.

Beyond that, he's just happy his mother-in-law might finally be able to hear him talk — she balked at the initial price of around $2,000 per ear for her aids.

"This weekend was my mother-in-law's 93rd birthday and all she said was 'what?' and 'huh,'" he said.

Gabrielle Bienasz is a staff writer at Entrepreneur. She previously worked at Insider and Inc. Magazine. 

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