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. 

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.

FDA regulations (in development)

  • OTC law established on August 18, 2017, 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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