Hearing aids are regulated by the United Sates Food and Drug Administration in the United States.

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1) Cost per hearing aid (without insurance)

2) Insurance coverage for hearing aids

3) Regulation of hearing aids approved for sale

4) Hearing aid purchasing pathways

Hearing Aid Policies in the United States

Yong, M., Willink, A., McMahon, C., McPherson, B., Nieman, C. L., Reed, N. S., & Lin, F. R. (2019). Access to adults' hearing aids: policies and technologies used in eight countries. Bulletin of the World Health Organization, 97(10), 699–710. https://doi.org/10.2471/BLT.18.228676

Access to adults’ hearing aids: policies and technologies used in eight countries

ㅡ  Typical price range: US$ 500–3000

ㅡ  Economy price range: US$ 300–500 (through mail order and retail stores)


Cost per hearing aid (without insurance) in US

ㅡ  Public insurance: different insurance plans cover different benefits. There is no coverage for hearing aids under the Original Medicare, there is some coverage under Medicare Advantage (Part C), and coverage for Veterans. It is not a mandatory benefit to be covered under Medicaid, but some States may include the coverage in their additional benefits.

ㅡ  Private insurance: largely employee-sponsored and through other third-party insurers. Most patients pay out-of-pocket


 Insurance coverage for hearing aids in US

Regulation of hearing aids approved for sale in US

All patients require medical clearance from an audiologist, general practitioner, or ear, nose and throat specialist to obtain a hearing aid, or must sign a medical waiver. Patients can purchase devices from an audiologist, hearing aid dispenser or other professional licensed to dispense hearing aids. By 2020, the Over-the-Counter Act passed in 2017 will create a Food and Drug Administration regulatory classification for hearing aids intended for mild and mild-to-moderate hearing loss that are directly available over the counter to adults

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