Cleared Traditional

K843246 - HEARING AID

K843246 is the FDA 510(k) clearance for HEARING AID by Unitron Industries, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K843246 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Jan 1985
Decision
156d
Days
Class 1
Risk

K843246 is an FDA 510(k) clearance for the HEARING AID, UNITRON UE12-PPL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Unitron Industries, Inc. (Port Huron, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 156 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 Unitron Industries, Inc. devices

Submission Details

510(k) Number K843246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date January 23, 1985
Days to Decision 156 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 89d · This submission: 156d
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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K843246.
HEARING AID 365
K850243 · Telex Communications, Inc. · Mar 1985
EARETTE HEARING AID OTICON MODEL E32S
K850762 · Oticon Corp. · Mar 1985
EARETTE HEARING AID OTICON E32U
K850763 · Oticon Corp. · Mar 1985
HEARING AID, UNITRON UE12-PP
K843245 · Unitron Industries, Inc. · Jan 1985
MODEL 363C HEARING AID
K844648 · Telex Communications, Inc. · Jan 1985
ULTRA & ULTRA MINATURE
K843789 · Qualitone · Dec 1984