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.
Recommended Actions
- Review existing or planned noise claims in labeling, promotion, and advertising materials
- Develop comprehensive scientific and/or clinical studies to substantiate all noise claims
- Establish a documentation system to maintain substantiating data
- Implement a process to make data readily available for FDA review or inspection
- Review current claims against Section 502 of FD&C Act to ensure compliance
- Monitor any changes in intended use or fundamental technology that might require 510(k) submission
- 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
- Air conduction hearing aids are exempt from premarket notification under FDAMA 1997
- Limitations of exemptions apply as per 21 CFR 874.9
- Major changes in intended use or fundamental scientific technology still require new 510(k)
Relevant Guidances
- Regulatory Requirements for Hearing Aids and Personal Sound Amplification Products (PSAPs)
Related references and norms
- 21 CFR 874.9: Limitations of exemptions for hearing aids
Original guidance
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