Cleared Traditional

K964508 - UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)

K964508 is the FDA 510(k) clearance for UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) 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 19-day FDA review.

K964508 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 1996
Decision
19d
Days
Class 1
Risk

K964508 is an FDA 510(k) clearance for the UNITRON MODEL ICON AOHP +4 (ICON AOHP +4). 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 November 27, 1996 after a review of 19 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 Unitron Industries, Inc. devices

Submission Details

510(k) Number K964508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1996
Decision Date November 27, 1996
Days to Decision 19 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
70d faster than avg
Panel avg: 89d · This submission: 19d
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 K964508.
UNITRON MODEL SOUND F/XP +4
K964502 · Unitron Industries, Inc. · Nov 1996
UNITRON MODEL SOUND F/X +4
K964503 · Unitron Industries, Inc. · Nov 1996
UNITRON MODEL ICON AOHPL +4
K964504 · Unitron Industries, Inc. · Nov 1996
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
K964510 · Unitron Industries, Inc. · Nov 1996
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
K964511 · Unitron Industries, Inc. · Nov 1996
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
K964530 · Miracle-Ear, Inc. · Nov 1996