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U.S. FDA Medical Device Hearing Aid Requirements: Hearing Aid

FDA Medical Device Definition: A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400)

Registrar Corp assists Hearing Aid companies with:

  • FDA Hearing Aid Establishment Registration
  • FDA Hearing Aid Listing
  • FDA Hearing Aid Label Requirements and Exceptions
  • FDA Hearing Aid Import Information
  • FDA Hearing Aid Detentions (Hearing Aid Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Hearing Aid Manufacturers (Hearing Aid Suppliers)
       - Hearing Aid Distributors
       - Hearing Aid Processors
       - Hearing Aid Repackers
       - Hearing Aid Relabelers
       - Hearing Aid Exporters
       - Hearing Aid Importers
For more information about Hearing Aid Medical Devices, simply click below:

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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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