Cleared Traditional

SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP

K962170 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Jul 1996

Decision

50d

Days

Class 1

Risk

About This 510(k) Submission

K962170 is an FDA 510(k) clearance for the SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP, 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 July 25, 1996, 50 days after receiving the submission on June 5, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K962170 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 1996
Decision Date	July 25, 1996
Days to Decision	50 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.