The document "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products" offers guidance to industry professionals and FDA staff on the regulatory requirements for hearing aids and PSAPs. It replaces the 2009 guidance and clarifies the differences between these products, as well as the regulatory controls applicable to each. It addresses stakeholder and consumer confusion, particularly after the FDA Reauthorization Act of 2017 mandated the creation of over the counter (OTC) hearing aids. The guidance defines hearing aids and PSAPs, outlines their regulatory requirements under the Federal Food, Drug, and Cosmetic Act, and discusses their distinct intended uses.
?The FDA distinguishes between hearing aids and Personal Sound Amplification Products (PSAPs) based on their intended use and regulatory classification:
- Intended Use: Designed to compensate for hearing loss and improve hearing ability.
- Features: Tailored to meet specific hearing needs, often programmable, and may include advanced features like noise reduction and feedback cancellation.
- Regulatory Classification: Considered medical devices and subject to FDA regulations for safety, efficacy, and quality. The regulation requires that over the counter (OTC) hearing aids must meet specific standards outlined in 21 CFR 800.30, covering aspects like labeling, performance, and design. Meeting these criteria qualifies the devices as "available" for over-the-counter purchase as per the FD&C Act. Hearing aids not meeting these standards are classified as prescription devices. The Rule repeals sales conditions specified in 21 CFR 801.421 and updates labeling requirements in 21 CFR 801.420 by transferring them to 21 CFR 801.422, focusing on prescription hearing aids. It ensures consistency with new labeling standards for OTC hearing aids in 21 CFR 800.30. Prescription hearing aids must now adhere to the requirements outlined in 21 CFR 801.422, along with other relevant regulations and special controls specified in their classification.
2.??? Personal Sound Amplification Products (PSAPs):
- Intended Use: Primarily intended for individuals with normal hearing or mild hearing impairment to amplify environmental sounds (e.g., for recreational activities or improved hearing in certain situations).
- Features: Generally, amplifies sounds without customization for hearing loss, may lack medical-grade features, and is not intended to replace hearing aids for those with significant hearing impairment.
- Regulatory Classification: Not classified as medical devices for hearing loss treatment; typically regulated as electronic products by the FDA. PSAPs are regulated under the Radiation Control for Health and Safety Act of 1968, focusing on electronic products emitting sonic vibrations like sound amplification equipment. Manufacturers of PSAPs must follow reporting procedures for accidental radiation incidents per 21 CFR Part 1002 and report defects as outlined in 21 CFR Part 1003. Additionally, they must meet requirements for repurchasing, repairing, or replacing electronic products under 21 CFR Part 1004.
