Regulation 

Hearing Aid

For hearing impaired user for treatment of mild-profound hearing loss:   

  • A medical product within FDA purview.

  • Air-conduction hearing aid with no wireless connectivity need to follow General Controls.
  • ​Air-conduction hearing aids with with wireless connectivity need to follow General and Special Controls​.

Personal Sound Amplification System (PSAP) or Sound Amplifiers

For non-hearing impaired consumer:

  • For recreational uses such as hunting, bird watching, listening to a distant speaker or soft sounds.

  • NOT intended to be used as hearing aids to compensate for hearing impairment.

  • NOT considered a medical product with FDA oversight.

Tinnitus Masker

  •  A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.

  • Within FDA purview. Need to follow General and Special Controls. 

Audiometer

  • Electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing test and assisting in the diagnosis of possible otologic disorders. Includes use of calibrated systems e.g. headphones.

  • Within FDA purview. Need to follow General and Special Controls.

  • FDA has NOT approved any hearing screener/test that is a software app that has been validated to provide accurate hearing screening/test results.

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