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Chapter 2

The FDA’s Advice to Hearing Aid Buyers

The First Thing You Need To Know

See Appendix A (“The FDA Regulations Governing the Sale of Hearing Aids” for a full text version of Section 801.421 – Hearing aid devices; conditions for sale).

The following paragraph from the Code of Federal Regulations summarizes the FDA’s attitude towards hearing aid dealers…

“Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged.”

By restricting the “…sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician” the FDA is warning you that hearing aid dealers are not licensed to give medical advice. But, as a result of intense lobbying pressure, the FDA allows you to sign a waiver wherein you affirm your understanding “…that the Food and Drug Administration has determined that my best health interest would be served if I had a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid” and further affirm that “I do not wish a medical evaluation before purchasing a hearing aid,” even though “the exercise of such a waiver is not in your best health interest and its use is strongly discouraged.”

Hearing Found’s position is the same as the FDA’s. See a physician specializing in the ear to ensure that you have no medically treatable condition of the ear, and that your ear canals are completely free of wax, before purchasing hearing aids.