OTC Hearing Aid

New Hearing Aid category

• Users will soon be able to buy directly, without visiting a hearing health professional.

• Same as traditional hearing aids, OTC hearing aids will be regulated as medical devices by the FDA.

• Can be fitted, controlled and adjusted by the user. 

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Potential Users 

• Adults with perceived mild to moderate hearing loss.

• Speech or other sounds seem muffled.

• Have trouble hearing when in a group, in a noisy area, on the phone, or can’t see who is talking.

• Have to ask others to speak more slowly or clearly, to talk louder, or to repeat what they said.

• Turn up the volume higher than other people prefer when watching TV or listening to the radio or music.

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FDA regulations (in development)

• OTC law established on August 18, 2026, as part of the FDA Reauthorization Act of 2017.

• Requires FDA to publish proposed regulations for public comment, and then to publish final regulations:

  • Ensure that the OTC devices are safe and effective. 

  • Set standards to help users to understand OTC hearing aids and who might benefit from them.

  • Labels will include warnings and other information for when to seek medical attention.

Availability

• FDA to publish draft OTC Rule for public comment prior to finalization.

• At this time, there are NO products that can claim to address hearing loss that are, or can claim to be OTC hearing aids. 

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