The otolaryngologist and the hearing aid delivery system: current federal regulations.

Abstract

New proposed rules and regulations concerning trade practices for the hearing aid industry have been developed in response to political pressures from Congress and consumer groups. Revisions to the trade regulations proposed by the Federal Trade Commission (FTC) include (1) more stringent limitations in advertising, (2) written permission to sell a hearing aid at home or in the buyer's place of business, and (3) the right of a buyer to cancel a hearing aid sale, rental, or lease within 30 days. Testimony on hearings regarding this rule are being reviewed by the FTC presiding officer. Food and Drug Administration national standards for the labeling and sale of hearing aids became effective Aug 15, 1977. A medical evaluation by a licensed physician is required before a hearing aid may be sold. Fully informed adults may request a waiver of this requirement for religious or personal beliefs, but a medical evaluation is mandatory for persons under 18 years of age. A User Instructional Brochure, which lists several conditions for which medical advice is advised, must be reviewed with the prospective buyer. In the recognition that some physicians may be dispensers of hearing aids, the Judicial Council of the American Medical Association has recommended that a physician may dispense hearing aids if it is in the best interest of the patient, but that a physician should not be encouraged to retail hearing aids in his office if other adequate community facilities exist.