Cleared Traditional

K942236 - AUDINA PREWIRES (FACEPLATE HEARING AID ...

K942236 is an FDA 510(k) clearance for AUDINA PREWIRES (FACEPLATE HEARING AID ..., manufactured by Audina Hearing Instrument. The device is a Class 1 Ear, Nose, Throat device with product code LRB cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K942236 · Audina Hearing Instrument · Ear, Nose, Throat device
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Jun 1994
Decision
39d
Days
Class 1
Risk

K942236 is an FDA 510(k) clearance for the AUDINA PREWIRES (FACEPLATE HEARING AID SERIES). Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Audina Hearing Instrument (Casselberry, US). The FDA issued a Cleared decision on June 17, 1994 after a review of 39 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 Audina Hearing Instrument devices

FDA 510(k) Submission Details - K942236

510(k) Number K942236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date June 17, 1994
Days to Decision 39 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 89d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

LRB Device Classification - Class 1, General Controls

Product Code LRB Face Plate Hearing Aid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
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 - LRB Face Plate Hearing Aid

All 17
Devices cleared under the same product code (LRB) and FDA review panel - the closest regulatory comparables to K942236.
MODULE PROGRAM
K942722 · Electone, Inc. · Sep 1994
ARTISAN PROGRAMMER & HEARING AID
K935048 · Telex Communications, Inc. · Feb 1994
GOLD K AMP, ITE
K933037 · Electone, Inc. · Aug 1993
GOLD AF MODULE, ITE
K933038 · Electone, Inc. · Aug 1993
GOLD L MODULE, ITE
K933039 · Electone, Inc. · Aug 1993
GOLD CD MODULE, ITE
K933040 · Electone, Inc. · Aug 1993