FDA
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 be in the language provided by the FDA.
- 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 the predominate method of communication used during the sale.
- Medical waivers and medical clearances shall 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).
» Read the FDA Sec. 801.421 Hearing aid devices; conditions for sale.
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