Prior to 1977, hearing aids as a class of product were no different than radios or TVs, and it took no special licensing or training whatsoever to be in the business. However, due to widespread abusive business practices, like door-to-door sales and false advertising (see Appendix C, “Justice Department Lawsuit”), the FDA decided to regulate the industry in 1977.
Another cause for this action is that serious medical conditions of the ear can be present with hearing loss. Since people oftentimes confuse a hearing test with a physician’s evaluation, the medical community asked the FDA to require that anyone buying a hearing aid be made to undergo a medical evaluation before purchasing.
The FDA agreed. It declared hearing aids to be a Class-1 medical device and adopted a requirement that anyone purchasing one must first present the dealer with a written statement from a physician advising that the person had been medically evaluated and cleared. However, the FDA made the medical clearance requirement subject to the buyer’s approval – meaning that an adult warned against doing so could waive the evaluation requirement by signing a medical waiver statement. (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).
An unforeseen consequence of the medical waiver is its widespread use by traditional dealers as a way to avoid sending their prospects to an MD who might also sell hearing aids. They simply have all purchasers sign a statement with the following FDA approved wording:
“I have been advised by _____________ (Hearing aid dispenser’s name) 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. I do not wish a medical evaluation before purchasing a hearing aid.”
Without question, anyone considering hearing aids should first be examined by an MD specializing in the ear (ENT). If it is determined that no medical condition is present, the ENT should then provide a signed medical clearance and a copy of the hearing test. At this point – just as with eyeglasses – you are free to go to the competitive market and make your best deal on hearing aids. In other words – approach the purchase of hearing aids from the perspective of a customer – not a patient. Do so, and you will save thousands of dollars.