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Noise Claims in Labeling for Air Conduction Hearing Aids

This guidance clarifies that manufacturers of air conduction hearing aids are no longer required to submit 510(k) premarket notifications for noise claims in their labeling, while emphasizing the need for substantiating data to support such claims.

  1. Review existing or planned noise claims in labeling, promotion, and advertising materials
  2. Develop comprehensive scientific and/or clinical studies to substantiate all noise claims
  3. Establish a documentation system to maintain substantiating data
  4. Implement a process to make data readily available for FDA review or inspection
  5. Review current claims against Section 502 of FD&C Act to ensure compliance
  6. Monitor any changes in intended use or fundamental technology that might require 510(k) submission
  7. Create a procedure to evaluate future claims against the requirements for substantiation

Key Considerations

Clinical testing

  • Scientific and/or clinical studies must be developed to substantiate noise claims
  • Data must be maintained at manufacturer’s facility
  • Data must be available for FDA review upon request

Labelling

  • Noise claims can be included in labeling, promotion, and advertising materials without requiring new 510(k)
  • Unsubstantiated claims may result in device misbranding under Section 502 of FD&C Act

Other considerations

  • 21 CFR 874.9: Limitations of exemptions for hearing aids

Original guidance

  • Noise Claims in Labeling for Air Conduction Hearing Aids
  • HTML / PDF
  • Issue date: 1998-10-20
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: bca7930dad1422007ea6e5731bed3858
This post is licensed under CC BY 4.0 by the author.