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Regulatory Standards

The U.S. hearing aid industry adheres to comprehensive federal regulations governing both hearing aids and hearing aid sales practices. The U.S. Food and Drug Administration (FDA) enforces regulations that deal specifically with the manufacture and sale of hearing aids because these products are recognized as medical devices. The Federal Trade Commission (FTC) is responsible for monitoring the advertising and marketing practices of every business in America, including hearing aid dispensers.

The most notable federal regulation is the FDA's Hearing Aid Rule promulgated in August 1977. The rule requires that prior to the sale of a hearing aid, the practitioner advise the patient that it is in their best health interest to see a physician, preferably one specializing in diseases of the ear, before purchasing a hearing aid. The rule requires that a person obtain a medical evaluation of hearing loss within six months prior to obtaining a hearing aid or sign a waiver. The waiver provision is included to protect individual rights and freedom of choice. The FDA pointed out that medical evaluation by a physician is necessary in determining the cause of, and the pathology associated with, the patient's hearing loss.

A patient age 18 or older can sign a waiver for a medical examination, but dispensers must advise the patient that waiving the examination is not in the patient's best health interest.

The FDA regulations require that a user instruction brochure be provided prior to purchase that illustrates and describes its operation, use and care. The brochure also must list sources for repair and maintenance and include a statement that the use of a hearing aid may be only part of a rehabilitative program.

Dispensers are required to advise a prospective patient to consult promptly with a licensed physician (preferably a physician who specialized in diseases of the ear) if it is determined through inquiry, actual observation or review of any other available information that the prospective user has any of eight noted otologic conditions.

Under the Federal Trade Commission Act, the FTC can take action against a company that misleads or deceives consumers. The Magnuson-Moss Warranty Act, which the FTC enforces, provides consumers with certain protections relating to warranties. This act requires a company offering a warranty to fully disclose all its items and conditions. In addition, the FTC mandates a three-day period that offers consumers who purchase any products outside the seller's place of business the right to cancel the sale within 72 hours and obtain a full refund.

In addition to federal regulations, all states have specific laws that apply to the sale of hearing aids. All practitioners engaged in the fitting and dispensing of hearing aids must comply with all licensing requirements existing in the state of their individual practice. The state Attorney General's Office can provide consumers with particular information about state laws that apply to the sale of hearing aids and whether hearing aid dispensers must be licensed or registered by the state.

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