Cleared Traditional

IN-TH-EAR HEARING AID

K850123 · General Hearing Instruments, Inc. · Ear, Nose, Throat

Mar 1985

Decision

66d

Days

Class 1

Risk

About This 510(k) Submission

K850123 is an FDA 510(k) clearance for the IN-TH-EAR HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by General Hearing Instruments, Inc. (Roanoke, US). The FDA issued a Cleared decision on March 21, 1985, 66 days after receiving the submission on January 14, 1985. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K850123 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 1985
Decision Date	March 21, 1985
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

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.