Cleared Traditional

K962170 - SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP

K962170 is an FDA 510(k) clearance for SIEMENS VITA 160 SERIES POCKET HEARING ..., manufactured by Siemens Hearing Instruments, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K962170 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
50d
Days
Class 1
Risk

K962170 is an FDA 510(k) clearance for the SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K962170

510(k) Number K962170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 90d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 952
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K962170.
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
K962228 · Ototech Intl., Inc. · Aug 1996
MT10P, MT60-PP, MT60-AGC0, AND MT60
K962847 · Micro-Tech Hearing Instruments · Aug 1996
PHILIPS 71 SERIES
K961770 · Philips Hearing Instruments Co. · Aug 1996
IN-THE-EAR
K961827 · Qualitone · Jul 1996
RIONET HEARING AID HB53-K
K961907 · Authorized Hearing Systems, Inc. · Jul 1996
PHONAK SONA P2
K961653 · Phonak, Inc. · May 1996