[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.1090]

[Page 340-341]
 
                        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 B--Diagnostic Devices
 
Sec. 874.1090  Auditory impedance tester.

    (a) Identification. An auditory impedance tester is a device that is 
intended to change the air pressure in the external auditory canal and 
measure and graph the mobility characteristics of the tympanic membrane 
to evaluate the functional condition of the middle ear. The device is 
used to determine abnormalities in the mobility of the tympanic membrane 
due to stiffness, flaccidity, or the presence of fluid in the

[[Page 341]]

middle ear cavity. The device is also used to measure the acoustic 
reflex threshold from contractions of the stapedial muscle, to monitor 
healing of tympanic membrane grafts or stapedectomies, or to monitor 
followup treatment for inflammation of the middle ear.
    (b) Classification. Class II.