[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.421]

[Page 30]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 801--LABELING--Table of Contents
 
          Subpart H--Special Requirements for Specific Devices
 
Sec. 801.421  Hearing aid devices; conditions for sale.

    (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.

    (b) Opportunity to review User Instructional Brochure. Before 
signing any statement under paragraph (a)(2)(iii) of this section and 
before the sale of a hearing aid to a prospective user, the hearing aid 
dispenser shall:
    (1) 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;
    (2) Review the content of the User Instructional Brochure with the 
prospective user orally, or in the predominate method of communication 
used during the sale;
    (3) Afford the prospective user an opportunity to read the User 
Instructional Brochure.
    (c) Availability of User Instructional Brochure. (1) Upon request by 
an individual who is considering 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.
    (2) In addition to assuring 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:
    (i) Provide sufficient copies of the User Instructional Brochure to 
sellers for distribution to users and prospective users;
    (ii) Provide a copy of the User Instructional Brochure to any 
hearing aid professional, user, or prospective user who requests a copy 
in writing.
    (d) Recordkeeping. The dispenser shall retain for 3 years after the 
dispensing of a hearing aid a copy of any written statement from a 
physician required under paragraph (a)(1) of this section or any written 
statement waiving medical evaluation required under paragraph 
(a)(2)(iii) of this section.
    (e) Exemption for group auditory trainers. Group auditory trainers, 
defined as a group amplification system purchased by a qualified school 
or institution for the purpose of communicating with and educating 
individuals with hearing impairments, are exempt from the requirements 
of this section.

[42 FR 9296, Feb. 15, 1977]