In accordance with the Act, a licensed audiologist or licensed intern in audiology registered to fit and dispense hearing instruments shall:
- (1) adhere to the federal Food and Drug Administration regulations in accordance with 21 Code of Federal Regulations §801.420 and §801.421;
- (2) insure that all equipment used by the licensee within his or her scope of practice shall be calibrated to insure compliance with the American National Standards Institute (ANSI), S3.6, 1989, Specification for Audiometers, or S3.6, 1996, Specification for Audiometers;
(3) receive a written statement before selling a hearing instrument that is signed by a licensed physician preferably one who specializes in diseases of the ear and states that the client's hearing loss has been medically evaluated during the preceding six-month period and that the client may be a candidate for a hearing instrument. If the client is age 18 or over, the registered audiologist or intern in audiology may inform the client that the medical evaluation requirement may be waived as long as the registered audiologist or intern in audiology:
- (A) informs the client that the exercise of the waiver is not in the client's best health interest;
- (B) does not encourage the client to waive the medical evaluation; and
- (C) gives the client an opportunity to sign this statement: "I have been advised by (the name of the individual dispensing the hearing instrument) 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 instrument. I do not wish medical evaluation before purchasing a hearing instrument;" and
- (4) verify appropriate fit of the hearing instrument(s), which may include real ear measures, functional gain measures, or other professionally accepted measures.
Source Note:The provisions of this §111.201 adopted to be effective October 1, 2016, 41 TexReg 4441.