FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; EAR, NOSE, AND THROAT DEVICES; CLASSIFICATION OF THE COMBINED ACOUSTIC AND ELECTRICAL EXTERNAL STIMULATION DEVICE FOR THE RELIEF OF TINNITUS

WASHINGTON, June 10 -- Food and Drug Administration has issued a rule called: Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus.

The rule was published in the Federal Register on June 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the combined acoustic and el...