Regulatory Requirements for Hearing Aids and Personal Sound Amplification Products (PSAPs)
This guidance clarifies the regulatory requirements for hearing aids and Personal Sound Amplification Products (PSAPs), distinguishing between their intended uses and applicable regulations. It covers air-conduction and bone-conduction hearing aid devices but excludes cochlear implants, implantable middle ear devices, group hearing aids, master hearing aids, and tinnitus maskers.
What You Need to Know? 👇
What is the difference between hearing aids and Personal Sound Amplification Products (PSAPs)?
Hearing aids are medical devices intended to aid or compensate for hearing impairment, while PSAPs are electronic products designed to amplify sounds for non-hearing impaired consumers in specific environments like hunting or lectures.
Are PSAPs regulated by the FDA as medical devices?
No, PSAPs are not regulated as medical devices because they’re not intended to diagnose, treat, or compensate for hearing impairment. However, they must comply with electronic product radiation safety requirements under the Radiation Control for Health and Safety Act.
What regulatory requirements apply to over-the-counter (OTC) hearing aids?
OTC hearing aids must comply with 21 CFR 800.30 requirements including labeling, performance, and design standards. They must also meet applicable classification regulation requirements and special controls for their specific device type.
Can manufacturers market PSAPs as alternatives to hearing aids?
No, marketing PSAPs as alternatives to hearing aids or targeting consumers with hearing loss would cause the product to meet the device definition, making it subject to hearing aid regulations rather than PSAP requirements.
What classification categories exist for hearing aid devices?
Hearing aids are classified as Class I devices (exempt from 510(k)), Class II devices (requiring 510(k) premarket notification), or Class II devices exempt from 510(k) but subject to special controls.
What labeling claims would make a PSAP subject to hearing aid regulations?
Claims suggesting the product addresses hearing loss, is indicated for hearing-impaired users, provides hearing loss optimization, or serves as a hearing aid alternative would trigger device classification and hearing aid regulatory requirements.
What You Need to Do 👇
Recommended Actions
- Determine if your product is a hearing aid or PSAP based on intended use and claims
- For hearing aids:
- Identify applicable device classification and requirements
- Ensure compliance with specific labeling requirements
- Implement quality system requirements
- Submit appropriate premarket submissions if required
- For PSAPs:
- Ensure compliance with electronic product radiation control requirements
- Implement reporting procedures for radiation occurrences
- Avoid making claims related to hearing loss or impairment
- Review all product claims and marketing materials to ensure they align with intended product category
- Establish procedures for:
- Adverse event reporting (hearing aids)
- Radiation occurrence reporting (PSAPs)
- Product repairs and replacements
- Maintain documentation demonstrating compliance with applicable requirements
Key Considerations
Labelling
- Specific information must be included to help identify health threats if left undiagnosed
- Must include information to avoid unnecessary and inappropriate hearing aid use
- Must help consumers choose appropriate and safe devices
- OTC hearing aids must comply with labeling requirements in 21 CFR 800.30
- Prescription hearing aids must comply with labeling requirements in 21 CFR 801.422
Safety
- PSAPs must comply with radiation safety requirements
- Manufacturers must report accidental radiation occurrences
- Requirements for repurchase, repair, or replacement of electronic products apply
Other considerations
- Hearing aids are regulated as medical devices under FD&C Act
- PSAPs are not medical devices but are regulated as electronic products
- Product claims and intended use determine whether a product is a hearing aid or PSAP
- Claims addressing hearing loss or impairment make the product a medical device
- OTC hearing aids must meet specific performance and design requirements
Relevant Guidances 🔗
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Labeling Requirements and Recommendations for Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms 📂
- 21 CFR 800.30: Requirements for OTC hearing aids
- 21 CFR 801.422: Requirements for prescription hearing aids
- 21 CFR Part 1002: Electronic product radiation safety requirements
- 21 CFR Part 1003: Notification of defects in electronic products
- 21 CFR Part 1004: Repurchase, repairs, or replacement of electronic products