265 CMR 6.03 - Medical Evaluation Requirements/Clients Younger than 18 Years Old

(1) Medical Evaluation Requirements.
(a) General. Except as provided in 265 CMR 6.03(1)(b), a hearing aid dispenser shall not sell a hearing aid unless the prospective user has presented to the hearing aid dispenser a written statement signed by a licensed physician that states that the patient's hearing loss has been medically evaluated and the patient may be considered a candidate for a hearing aid. The medical evaluation must have taken place within the preceding six months.
(b) Waiver to the Medical Evaluation Requirements. If the prospective hearing aid user is 18 years of age or older, the hearing aid dispenser may afford the prospective user an opportunity to waive the medical evaluation requirement of 265 CMR 6.03(1) provided that the hearing aid dispenser:
1. Informs the prospective user that the exercise of the waiver is not in the user's best health interest;
2. Does not in any way actively encourage the prospective user to waive such a medical evaluation; and
3. Affords the prospective user the opportunity to sign the following statement: "I have been advised by -------- -------- (Hearing aid dispenser'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."
(2) Clients Younger than 18 Years Old. A registrant or apprentice shall not sell a hearing instrument to a person younger than 18 years old unless the client, a parent, or guardian has presented to the registrant or apprentice a written statement signed by a licensed physician that states that the patient's hearing loss has been medically evaluated and the patient may be considered a candidate for a hearing instrument. The physician's evaluation must have taken place within the preceding six months.
(3) If, upon inspection of the ear canal during a hearing aid fitting and upon questioning of the client, there is recent history of infection, any observable anomaly, deformity of ear, unilateral loss of hearing within 90 days, bilateral loss of hearing within 90 days, evidence of cerumen or other occlusion, pain in the ear, discharge, ear bone gap at 15 Db at 500 hz, 1000 hz, and 2000 hz or dizziness, the client shall be instructed to see a physician (preferably a physician who specializes in diseases of the ear). A hearing aid shall not be fitted until medical clearance is obtained for the condition noted or a waiver of informed consent for the specific condition noted or complained of is signed by the client. If, upon the client's return, the condition noted is no longer observable and the client signs a medical waiver, a hearing aid may be fitted.

Notes

265 CMR 6.03
Amended by Mass Register Issue 1319, eff. 8/12/2016.

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