Cleared Traditional

K823365 - HEARING AID UE-10

K823365 is the FDA 510(k) clearance for HEARING AID UE-10 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 12-day FDA review.

K823365 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Nov 1982
Decision
12d
Days
Class 1
Risk

K823365 is an FDA 510(k) clearance for the HEARING AID UE-10. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Unitron Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 12 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 K823365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1982
Decision Date November 22, 1982
Days to Decision 12 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
77d faster than avg
Panel avg: 89d · This submission: 12d
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 K823365.
HEARING AID #G6H & G6T
K823431 · Widex Hearing Aid Co., Inc. · Dec 1982
MODELS G6H, G6T, G1H & G1T
K823460 · Widex Hearing Aid Co., Inc. · Dec 1982
HEARING AID UE-10-H
K823366 · Unitron Industries, Inc. · Nov 1982
HEARING AID, UNITRON MODEL UE7
K822805 · Unitron Industries, Inc. · Oct 1982
PHONIC EAR-PE 845-PPC
K822779 · Phonic Ear, Inc. · Oct 1982
HEARING AID, UNITRON UE3-D/DN
K822506 · Unitron Industries, Inc. · Sep 1982