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Notice - Effective December 12, 2016
The Food and Drug Administration has released a guidance document indicating FDA does not intend to enforce the medical clearance and recordkeeping requirements found in 21 C.F.R. 801.421(a) and (d) at this time. You may view the guidance document here. Per the FDA, this guidance is non-binding and may be revised in the future.
Per the guidance document, this only applies to Class I air-conduction hearing aids and Class II wireless air-conduction hearing aids. It does not apply to Class II bone-conduction hearing aids, hearing aids labeled as prescription only, and hearing aids for individuals under 18.
844 IAC 9-6-3(3) is not affected by this guidance and still remains in effect:
Section 3(3): A hearing aid dealer shall be required, but not be limited to, do the following: make reasonable efforts to obtain a consultation with a physician or audiologist whenever requested to do so by a client or by those responsible for a client’s care.
Further questions regarding the FDA guidance document should be directed to the FDA by contacting Eric Mann at 301-796-5620. Please note that neither the Committee nor its staff can provide legal advice or guidance.
All applicants for registration as a hearing aid dealer are required to pass the written examination before being permitted to take the practical examinations.
Darren R. Covington, J.D., Director
Jody Edens, Assistant Director
Terri Sherman, Customer Service Representative
Rejina Stigger, Customer Service Representative
Ronika Turner, Customer Service Representative
Staff Phone Number: (317) 234-2067
Staff Email Address: email@example.com
Indiana Professional Licensing Agency
Attn: Hearing Aid Dealer Committee
402 West Washington Street, W072
Indianapolis, Indiana 46204