Cleared Traditional

BINAURAL HEARING AID

K935366 · Telex Communications, Inc. · Ear, Nose, Throat

Jan 1994

Decision

70d

Days

Class 1

Risk

About This 510(k) Submission

K935366 is an FDA 510(k) clearance for the BINAURAL HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Telex Communications, Inc. (Lincoln, US). The FDA issued a Cleared decision on January 13, 1994, 70 days after receiving the submission on November 4, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K935366 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 1993
Decision Date	January 13, 1994
Days to Decision	70 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.