Cleared Traditional

TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION

K963915 · Telex Communications, Inc. · Ear, Nose, Throat

Nov 1996

Decision

39d

Days

Class 1

Risk

About This 510(k) Submission

K963915 is an FDA 510(k) clearance for the TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 8, 1996, 39 days after receiving the submission on September 30, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K963915 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 1996
Decision Date	November 08, 1996
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — General Controls
CFR Regulation	21 CFR 874.3300
Definition	An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.