The FDA OTC Hearing Aid Rule, In Plain English

Why you can now buy real hearing aids without a clinic visit.

What changed

For decades, hearing aids in the United States were medical devices that legally required a prescription, an appointment with an audiologist, and a fitting. Prices ran $4,000,$6,000 a pair, mostly cash, because Medicare doesn't cover them.

In August 2022, the FDA issued the OTC Hearing Aid Final Rule, which took effect October 17, 2022. The rule created a new product category, over-the-counter hearing aids, that adults 18 and older with perceived mild-to-moderate hearing loss can buy directly, without a prescription, without an audiologist visit, and without state-by-state dispenser licensing.

What an OTC hearing aid is (and isn't)

An OTC hearing aid is: a real FDA-regulated hearing aid, with the same digital sound processing, amplification, and feedback management as traditional clinic devices. It must meet FDA performance, safety, and labeling requirements.

An OTC hearing aid is NOT: a personal sound amplifier (PSAP). PSAPs are recreational sound boosters, useful for theater, birding, hunting, but not regulated as hearing aids and not appropriate for people with documented hearing loss. The iHEAR TReO is a PSAP, not a hearing aid.

Who OTC is for

• Adults 18 or older
• People with perceived mild-to-moderate hearing loss
• People who want to skip the clinic markup

If you suspect severe or profound hearing loss, sudden hearing loss, or have ear pain, drainage, or discomfort, see a licensed healthcare professional before buying any OTC device.

Why direct-to-consumer is now legal

Before the Final Rule, every hearing-aid sale had to go through a state-licensed dispenser or audiologist. The Final Rule preempted those state laws for OTC products, meaning direct manufacturers can ship OTC hearing aids to your door across all 50 states, with FDA labeling and a money-back trial period.

What OTCHealth offers

• HearingAssist, the OTC brand sold at Walmart, CVS, Walgreens, Target, Rite Aid, Best Buy, and Amazon since 2008 (now direct from OTCHealth)
• iHEAR Matrix, Bluetooth-enabled OTC hearing aid, engineered in Roseville, California
• iHEAR TReO, a Personal Sound Amplifier (PSAP), recreational use only

Every OTCHealth hearing aid ships with a 60-day money-back guarantee, a prepaid USPS return label, and a refund to your original payment method within 5 business days of return receipt. No restocking fees. No clinic visits. No appointment scheduling.

Sources: FDA Final Rule "Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids," published 21 CFR Part 800 et al., effective October 17, 2022. This page is for consumer education and does not constitute medical advice. Consult a licensed healthcare professional for hearing concerns.