D.C. Mun. Regs. tit. 22, r. 22-B10323

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10323 - HEARING AID DEVICES: CONDITIONS FOR SALE

10323.1

Except as provided in § 10323.2, 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 (6) months.

10323.2

If the prospective hearing aid user is eighteen (18) years of age or older, the hearing aid dispenser may afford the prospective user an opportunity to waive the medical evaluation requirement of § 10323.1 of this section provided that the hearing aid dispenser:

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

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

(c) Affords the prospective user the opportunity to sign the following statement:

"I have been advised by (Hearing aid dispenser's name) that the Department of Health 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 to have a medical evaluation before purchasing a hearing aid."

10323.3

Before signing any statement under § 10323.2(c) of this section and before the sale of a hearing aid to a prospective user, the hearing aid dispenser shall:

(a) Provide the prospective user a copy of the User Instructional Brochure for a hearing aid that has been, or may be, selected for the prospective user;

(b) Review the content of the User Instructional Brochure with the prospective user orally, or in the predominate method of communication used during the sale; and

(c) Afford the prospective user an opportunity to read the User Instructional Brochure.

10323.4

Upon request by an individual who is considering the purchase of a hearing aid, a dispenser shall, with respect to any hearing aid that he dispenses, provide a copy of the User Instructional Brochure for the hearing aid or the name and address of the manufacturer or distributor from whom a User Instructional Brochure for the hearing aid may be obtained.

10323.5

In addition to ensuring that a User Instructional Brochure accompanies each hearing aid, a manufacturer or distributor shall, with respect to any hearing aid that he manufactures or distributes:

(a) Provide sufficient copies of the User Instructional Brochure to sellers for distribution to users and prospective users; and

(b) Provide a copy of the User Instructional Brochure to any hearing aid professional, user, or prospective user who requests a copy in writing.

10323.6

The dispenser shall retain for three (3) years after the dispensing of a hearing aid a copy of any written statement required under § 10323.1 of this section from a physician or any written statement waiving a medical evaluation required under § 10323.2(c).

10323.7

Group auditory trainers, defined as a group amplification system, that a qualified school or institution purchases for the purpose of communicating with and educating individuals with hearing impairments, are exempt from the requirements in this section.

D.C. Mun. Regs. tit. 22, r. 22-B10323

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.