MEDICAL WAIVER: I AM OVER 18 YEARS OF AGE. I HAVE BEEN ADVISED BY THE SELLER THAT MY BEST HEALTH INTEREST WOULD BE SERVED IF I HAD A MEDICAL EVALUATION BY A LICENSED PHYSICIAN BEFORE PURCHASING A HEARING AID. I DO NOT WISH A MEDICAL EVALUATION.
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)