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Hearing Aid Buyers Beware

The U.S. Food and Drug Administration has recently eliminated the need for people who sell hearing aids to obtain medical waivers from consumers.

For many years the Food and Drug Administration has required anyone who sells hearing aids to advise people that it is in their best interest to see a medical doctor especially if the hearing problem could be a treatable condition. The consumer has the right to sign a medical waiver saying they do not want a medical exam. Many consumers have been unaware of that mandate and there are instances where they have unknowingly signed medical waivers especially if they are cloaked with other paperwork. Some hearing aid salesman have entirely ignored this requirement.

The FDA says that people who sell hearing aids are no longer required to have these waivers signed. I do not know how this will affect state laws. For instance, this requirement is still part of Florida licensure laws.

I personally have mixed emotions about this FDA deregulation. Consumers who have signed these waivers in the past may have lost legal grounds for suing a salesman for performing an improper exam or negligently managing their problem. It is possible that this change may benefit the consumer because deregulating the hearing industry may give consumers more cost effective hearing aids. Some types of hearing aids may be available over the counter without a hearing test. You will see that sometime within the next three years.

Of course the down side to deregulation is that serious conditions and treatable hearing losses may be missed by unscrupulous and untrained sales people. Another concern of mine is that over the counter unregulated hearing aid sales may disappoint the consumer to the point that they stop searching for better solutions.

My advice to everyone is to see an Audiology Doctor, not a salesman when considering evaluation for hearing aids. At least you will get a proper exam and enough information to make a sound judgment about what kind of hearing aid or medical treatment is best for you.

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Daniel Gardner, M.S.

Daniel Gardner, M.S.

Founder and CEO of Gardner Audiology
Daniel Gardner, M.S.

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