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U.S. FDA Medical Device Group Hearing Aid or Group Auditory Trainer Requirements: Group Hearing Aid or Group Auditory Trainer

FDA Medical Device Definition: A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems

Registrar Corp assists Group Hearing Aid or Group Auditory Trainer companies with:

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