An Update on the FDA’s Recent Decision to Exclude the Need for Medical Clearance
In a December 7, 2016 press release, the U.S. Food and Drug Administration announced “important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately.”
Our current Florida Statues (Title XXXII, Chapter 468.1225, Number 4) state that “A licensed audiologist who fits and sells hearing aids shall obtain the following medical clearance: If, upon inspection of the ear canal with an otoscope in the common procedure of fitting a hearing aid and upon interrogation of the client, there is any recent history of infection or any observable anomaly, the client shall be instructed to see a physician, and a hearing aid shall not be fitted until medical clearance is obtained for the condition noted. If, upon return, the condition noted is no longer observable and the client signs a medical waiver, a hearing aid may be fitted. Any person with a significant difference between bone conduction hearing and air conduction hearing must be informed of the possibility of medical or surgical correction.”
The FLAA Board of Directors has asked for guidance from the Florida Licensing Board regarding the potential conflict between FDA guidelines and the current Florida Statues. We are currently awaiting their response. In the meantime, we caution and encourage audiologists to follow the State laws; though the FDA is not “enforcing” the requirement, they are not planning to remove it from their guidelines.
We will continue to update the membership as additional information is obtained.
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