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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.

  1. Determine if your product is a hearing aid or PSAP based on intended use and claims
  2. 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
  3. 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
  4. Review all product claims and marketing materials to ensure they align with intended product category
  5. Establish procedures for:
    • Adverse event reporting (hearing aids)
    • Radiation occurrence reporting (PSAPs)
    • Product repairs and replacements
  6. 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

  • 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

Original guidance

  • Regulatory Requirements for Hearing Aids and Personal Sound Amplification Products (PSAPs)
  • HTML / PDF
  • Issue date: 2022-08-17
  • Last changed date: 2022-10-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 169cfc6b8fb098f3753adc2ecea424a3
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