[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: 21CFR874.3320]

[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. 874.3320  Group hearing aid or group auditory trainer.

    (a) Identification. A group hearing aid or group auditory trainer is 
a hearing aid that is intended for use in communicating simultaneously 
with one or more listeners having hearing impairment. The device is used 
with an associated transmitter microphone. It may be either monaural or 
binaural, and it provides coupling to the ear through either earphones 
or earmolds. The generic type of device includes three types of 
applications: hardwire systems, inductance loop systems, and wireless 
systems.
    (b) Classification. Class II.