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.
What You Need to Know? 👇
What are the 510(k) requirements for hearing aids with noise claims?
Under FDAMA 1997, air conduction hearing aids are exempt from 510(k) premarket notification. Adding noise claims to labeling doesn’t exceed exemption limitations and doesn’t require new 510(k) submission, unless it involves major intended use changes.
What documentation must manufacturers maintain for hearing aid noise claims?
Manufacturers must develop and maintain substantiating data from scientific and/or clinical studies at their facility. This data must be available for FDA review upon request or during inspections to support their noise claims.
When would a hearing aid with noise features require a new 510(k) submission?
A new 510(k) is required only if there’s a major change in intended use or fundamental scientific technology change. Simply adding noise claims to labeling, promotion, or advertising materials doesn’t trigger this requirement.
What are the consequences of unsubstantiated noise claims in hearing aid labeling?
Unsubstantiated claims may result in the device being considered misbranded under Section 502 of the Federal Food, Drug and Cosmetic Act, potentially leading to regulatory enforcement actions by the FDA.
What types of studies can support noise claims in hearing aid labeling?
Manufacturers should develop substantiating data from scientific and/or clinical studies. The guidance doesn’t specify exact study types, but the data must be sufficient to support claims like improved speech understanding in noisy environments.
Are there specific limitations for hearing aid exemptions under FDAMA?
Yes, exemptions are limited by 21CFR 874.9. Major changes in intended use or fundamental scientific technology changes would exceed these limitations and require 510(k) submission, but simple noise claim additions don’t.
What You Need to Do 👇
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 đź”—
Related references and norms đź“‚
- 21 CFR 874.9: Limitations of exemptions for hearing aids