Cleared Traditional

K943854 - 3M MODEL 8233 HEARING INSTRUMENT

K943854 is the FDA 510(k) clearance for 3M MODEL 8233 HEARING INSTRUMENT by 3M Company. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K943854 · 3M Company · Ear, Nose, Throat device
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Jan 1995
Decision
169d
Days
Class 1
Risk

K943854 is an FDA 510(k) clearance for the 3M MODEL 8233 HEARING INSTRUMENT. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 169 days - an extended review 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: 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 3M Company devices

Submission Details

510(k) Number K943854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1994
Decision Date January 24, 1995
Days to Decision 169 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
80d slower than avg
Panel avg: 89d · This submission: 169d
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 K943854.
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
K946323 · Unitron Industries, Inc. · Jan 1995
UNITRON MODEL SOUNG F/S
K946264 · Unitron Industries, Inc. · Jan 1995
PHONAK SONO-FORTE 332X-AZ
K946294 · Phonak, Inc. · 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
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944174 · Siemens Hearing Instruments, Inc. · Dec 1994