The Food and Drug Administration (FDA) regulates the conditions for sale of specific medical devices, including hearing aid devices. These regulations are summarized below:
Summary of FDA Regulations
- Prospective hearing aid users must obtain a medical clearance from a physician (preferably one who specializes in diseases of the ear) prior to being fit with amplification. The medical clearance must have occurred in the last six months. If the prospective user is over 18 years of age, they may waive this medical clearance and, instead, complete a medical waiver. The medical waiver must use language provided by the FDA. View the FDA waiver language.
- Prospective hearing aid users under the age of 18 years of age obtain a medical clearance from a physician (preferably one who specializes in diseases of the ear) prior to being fit with amplification. The medical clearance must have occurred in the last six months. Neither the child or their parent or guardian may waive this medical clearance requirement.
- Hearing aid users must be provided with the User Instructional Brochure provided by the hearing aid manufacturer. Review of this brochure must take place orally or in the predominate method of communication used during the sale.
- Medical waivers and medical clearances must be retained by the dispenser for a minimum of three years. (Note: HIPAA requires patient medical records be retained for a minimum of six years after the last date of service).
Additional FDA Resources
- FDA Hearing Aids Web site
- FDA Hearing Aids Web site – Personal Sound Amplification Products
- FDA Consumer Update article – Hearing Loss Signals Need for Diagnosis
- FDA Sec. 801.421 Hearing aid devices; conditions for sale
- FDA Warning Signs of Ear Disease
Sample ADA Member Documents
- Medical Clearance
- Medical Waiver
The federal (and, in many cases, state) Anti-Kickback statutes make it is crime to give or receive anything of value in exchange for referring, ordering, soliciting or recommending an item or service that is paid in whole or in part by a federal payer, such as Medicare, Medicaid, TriCare or the Veteran’s Administration. Learn more per review of your state licensure law, or review the fraud and abuse information. Additional information can be located at the Office of the Inspector General.
This federal (and, in many cases) state statute prohibits any provider from knowingly submitting any false or fraudulent claim to any federal (or state) payer. Learn more, or review fraud and false claims information.