[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: 21CFR874.3300]

[Page 366-367]
 
                        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. 874.3300  Hearing Aid.


    (a) Identification. A hearing aid is wearable sound-amplifying 
device that is intended to compensate for impaired hearing. This generic 
type of device includes the air-conduction hearing aid and the bone-
conduction hearing aid, but excludes the group hearing aid or group 
auditory trainer (Sec. 874.3320), master hearing aid (Sec. 874.3330), 
and tinnitus masker (Sec. 874.3400).
    (b) Classification. (1) Class I (general controls) for the air-
conduction hearing aid. The air-conduction hearing aid is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 874.9.

[[Page 367]]

    (2) Class II for the bone-conduction hearing aid.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]