[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: 21CFR874.3950]

[Page 353]
 
                        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. 874.3950  Transcutaneous air conduction hearing aid system.

    (a) Identification. A transcutaneous air conduction hearing aid 
system is a wearable sound-amplifying device intended to compensate for 
impaired hearing without occluding the ear canal. The device consists of 
an air conduction hearing aid attached to a surgically fitted tube 
system, which is placed through soft tissue between the post auricular 
region and the outer ear canal.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid 
System (TACHAS); Guidance for Industry and FDA.'' See Sec. 874.1 for the 
availability of this guidance document.

[67 FR 67790, Nov. 7, 2002]