FDA Regulation Regarding Hearing Aids

The Food and Drug Administration (FDA) has issued the following regulation regarding the dispensing of hearing aids: 

(a) Medical evaluation requirements –(1) General. Except as provided in paragraph (a)(2) of this section, 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 6 months. 

(2) 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 paragraph (a)(1) of this section provided that the hearing aid dispenser: 

(i) Informs the prospective user that the exercise of the waiver is not in the user’s best health interest; 

(ii) Does not in any way actively encourage the prospective user to waive such a medical evaluation; and 

(iii) 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. 

Related Resources