Cleared Traditional

TELEX MODEL M29 ITE CUSTOM HEARING AID

K922065 · Telex Communications, Inc. · Ear, Nose, Throat

May 1992

Decision

14d

Days

Class 1

Risk

About This 510(k) Submission

K922065 is an FDA 510(k) clearance for the TELEX MODEL M29 ITE CUSTOM HEARING AID, 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 May 18, 1992, 14 days after receiving the submission on May 4, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K922065 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 1992
Decision Date	May 18, 1992
Days to Decision	14 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.