In accordance with the Act, a licensed audiologist or licensed intern in audiology, who fits and dispenses hearing instruments, shall:     
       (1) adhere to the federal Food and Drug Administration regulations in accordance with 21 Code of Federal Regulations §801.422;      
       (2) ensure that all equipment used by the licensee within the licensee's scope of practice is calibrated in compliance with the American National Standards Institute (ANSI), S3.6, 1989, Specification for Audiometers, or S3.6, 1996, Specification for Audiometers;      
       (3) if the client is under age 18, 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. A written statement is not required for clients 18 years of age or older;      
       (4) verify appropriate fit of the hearing instrument(s), which may include real ear measures, functional gain measures, or other professionally accepted measures; and      
       (5) use a written contract that contains the department's name, mailing address, telephone number, and Internet website address, when providing services in this state.      
     Source Note:        The provisions of this §111.201 adopted to be effective October 1, 2016, 41 TexReg 4441; amended to be effective August 1, 2020, 45 TexReg 5172; amended to be effective January 1, 2024, 48 TexReg 8363