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Over-the-counter hearing aids: Are they ready yet?

March 01, 2021

They're not yet FDA-approved, but the devices are available and safe — if you know what to look for.


When Congress passed the Over-the-Counter (OTC) Hearing Aid Act in 2017, it opened up a new world of possibility for people with hearing loss. Instead of paying $5,000 for a pair of FDA-approved hearing aids and follow-up service, you could pay hundreds of dollars for an OTC pair from any seller — no doctor appointments, hearing tests, or fittings needed. The devices would have the same fundamental technology as traditional hearing aids, they'd be targeted to people with perceived mild-to-moderate hearing loss, and the FDA would ensure quality by regulating and approving the OTC devices.

But almost four years later, the OTC hearing aid category and its safety and labeling rules are still tied up in red tape.

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