[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3400]

[Page 367]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874_EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart D_Prosthetic Devices
 
Sec. 874.3400  Tinnitus masker.

    (a) Identification. A tinnitus masker is an electronic device 
intended to generate noise of sufficient intensity and bandwidth to mask 
ringing in the ears or internal head noises. Because the device is able 
to mask internal noises, it is also used as an aid in hearing external 
noises and speech.
    (b) Classification. Class II. The special control for this device is 
patient labeling regarding:
    (1) Hearing health care professional diagnosis, fitting of the 
device, and followup care,
    (2) Risks,
    (3) Benefits,
    (4) Warnings for safe use, and
    (5) Specifications.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000]