Cleared Traditional

K944174 - LIFESOUND MULTIPLE SITUATION

K944174 is the FDA 510(k) clearance for LIFESOUND MULTIPLE SITUATION by Siemens Hearing Instruments, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K944174 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
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Dec 1994
Decision
123d
Days
Class 1
Risk

K944174 is an FDA 510(k) clearance for the LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS. 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 December 27, 1994 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Hearing Instruments, Inc. devices

Submission Details

510(k) Number K944174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date December 27, 1994
Days to Decision 123 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
34d slower than avg
Panel avg: 89d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 660
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K944174.
3M MODEL 8233 HEARING INSTRUMENT
K943854 · 3M Company · Jan 1995
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION
K934917 · Resound Corp. · Jan 1995
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
K943380 · Siemens Hearing Instruments, Inc. · Jan 1995
WIDEX MODEL LOGO 8S
K944518 · Widex Hearing Aid Co., Inc. · Dec 1994
AIR CONDUCTION HEARING AID
K944520 · Unitron Industries, Inc. · Dec 1994
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944645 · Siemens Hearing Instruments, Inc. · Dec 1994