Okla. Admin. Code § 310:266-15-1

Current through Vol. 42, No. 7, December 16, 2024

Section 310:266-15-1 - Over-the-counter hearing aid sales

(a) Over-the-counter (OTC) hearing aids that satisfy the conditions in Title 21 CFR Part 800, § 800.30 may be available for sale over-the-counter, without the supervision, prescription, or other order intervention or involvement of a licensed person, to consumers through in-person transactions, by mail, or online. The term "sale" includes leases or rentals.

(b) OTC hearing aids are required to satisfy the conditions imposed by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 9§ 301et seq. and the U.S. Food and Drug Administration rules in Title 21 CFR

Part 800 including without limitation:

(1) Labeling;

(2) Output limits;

(3) Electroacoustic performance limits;

(4) Design requirements; and

(5) Conditions for sale of an OTC hearing aid - consumer age minimum of 18 years old with perceived mild to moderate hearing impairment.

(c) A license issued under this Chapter is not required for the sale of OTC hearing aids. Persons licensed under this Chapter may sell OTC hearing aids.

Okla. Admin. Code § 310:266-15-1

Adopted by Oklahoma Register, Volume 40, Issue 23, August 15, 2023, eff. 9/11/2023