Cleared Traditional

K944174 - LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS

K944174 is an FDA 510(k) clearance for LIFESOUND MULTIPLE SITUATION, 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 123-day FDA review.

K944174 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K944174

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
33d slower than avg
Panel avg: 90d · This submission: 123d
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 K944174.
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
K943380 · Siemens Hearing Instruments, Inc. · Jan 1995
ORION PPM, PP, PP-D
K944777 · Rexton, Inc. · Dec 1994
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
K944359 · Rexton, Inc. · Dec 1994
MO4 SERIES
K944404 · Philips Hearing Instruments Co. · Dec 1994
WIDEX MODEL LOGO 8S
K944518 · Widex Hearing Aid Co., Inc. · Dec 1994
AIR CONDUCTION HEARING AID
K944520 · Unitron Industries, Inc. · Dec 1994