In an effort to improve access to hearing aids, the U.S. Food and Drug Administration (FDA) announced, it would no longer enforce medical clearance and waiver requirements related to hearing aid fitting. This announcement was made on December 7, 2016. The FDA will engage the federal rule-making process to modify current hearing aid rules accordingly. The FDA will continue to enforce the medical evaluation requirement for users under the age of 18. In Michigan, the Public Health Code Act 368 of 1978 (Section 333.16809) defers to the FDA regulations through the following statement:
The hearing aid labeling must still include information about medical conditions that should be evaluated by a licensed physician. The Michigan Audiology Coalition encourages all audiologists to follow good practice and refer patients for otolaryngology evaluations whenever retrocochlear or middle ear disorders are suspected.
Medical clearance may continue to be required by private insurance companies in order for hearing aid services to be paid. It is the provider’s responsibility to research an enrollee’s coverage to determine if medical clearance is required by their insurance provider.