Cleared Traditional

PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT

K952263 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Jun 1995

Decision

21d

Days

Class 1

Risk

About This 510(k) Submission

K952263 is an FDA 510(k) clearance for the PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on June 5, 1995, 21 days after receiving the submission on May 15, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K952263 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 1995
Decision Date	June 05, 1995
Days to Decision	21 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.