(A) An audiologist is responsible for the accuracy of an evaluation and shall utilize the results of appropriate evaluative procedures on every individual to whom he/she sells or fits a hearing aid. He/she shall retain the results on file for a period of at least three years for adult patients, or in the case of patients under the age of twenty-one years, three years past the date of the patient's twenty first birthday, or as required by federal or state laws and regulations.
(B) An audiologist shall advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if medical intervention is indicated by documented case history, actual observation, or review of any diagnostic audiological or other available information concerning the prospective user.
(C) An audiologist shall only sell hearing aids to a prospective user who has presented one of the following types of documentation, which document shall be retained by the audiologist for three years after the dispensing of a hearing aid:
(1) A written statement, signed by a licensed physician, that states the prospective user is his/her patient, the patient's hearing loss has been medically evaluated on a date that is within the six months preceding the sale, and the patient may be considered a candidate for a hearing aid.
(2) A written waiver of the medical evaluation signed by the prospective user provided all of the following conditions are met:
(a) The prospective user is at least eighteen years of age;
(b) The audiologist informs the prospective user that the exercise of the waiver is not in the user's best health interest;
(c) The audiologist does not in any way actively encourage the prospective user to waive such a medical evaluation;
(d) The waiver consists of the following statement printed in boldface type of the minimum of ten points:
"I have been advised by (Audiologist"s name) 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 aid. I do not wish a medical evaluation before purchasing a hearing aid."; and
(e) The audiologist provides the prospective user with a copy of the signed waiver.
(D) The failure to comply with the procedures and requirements of this rule shall constitute the committing of fraud, deception, or misrepresentation in the practice of audiology, committing an act of dishonorable, immoral, or unprofessional conduct while engaging in the practice of audiology, or any other conduct enumerated in section 4753.10 of the Revised Code.
119.032 review dates:
Promulgated Under: 119.03
Statutory Authority: 4753.05
Rule Amplifies: 4753.01(G) , 4753.05 , 4753.10
Prior Effective Dates: 11-16-92 (Emer.); 2-9-93; 6-27-97; 6-26-03