[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3310]

[Page 350]
 
                        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. 874.3310  Hearing aid calibrator and analysis system.

    (a) Identification. A hearing aid calibrator and analysis system is 
an electronic reference device intended to calibrate and assess the 
electroacoustic frequency and sound intensity characteristics emanating 
from a hearing aid, master hearing aid, group hearing aid or group 
auditory trainer. The device consists of an acoustic complex of known 
cavity volume, a sound level meter, a microphone, oscillators, frequency 
counters, microphone amplifiers, a distoration analyzer, a chart 
recorder, and a hearing aid test box.
    (b) Classification. Class II.