Cleared Traditional

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

K964639 · Telex Communications, Inc. · Ear, Nose, Throat

Jan 1997

Decision

63d

Days

Class 1

Risk

About This 510(k) Submission

K964639 is an FDA 510(k) clearance for the TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II, 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 January 21, 1997, 63 days after receiving the submission on November 19, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K964639 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 1996
Decision Date	January 21, 1997
Days to Decision	63 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.