CORRECTED: FDA Issues Immediately-in-Effect Guidance on Conditions for Sale for Air-Conduction Hearing Aids

Today, the FDA issued the "Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids." This guidance communicates the FDA’s intention to forego enforcement of medical evaluation and recordkeeping requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older. Hearing aid dispensers are still required to provide all prospective users an opportunity to review the User Instructional Brochure containing specific labeling requirements prior to the sale of a hearing aid device.

This guidance applies to the class I and class II subset of air-conduction hearing aids, meaning “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.” This guidance does not apply to bone-conduction hearing aids, or to prescription use hearing aids, such as those that are inserted deep in the ear canal.

Additionally, due to the specific needs and health concerns associated with hearing loss in children, the FDA will continue to enforce the medical evaluation requirement for all prospective hearing aid users under 18 years of age.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health