Cleared Traditional

K935867 - AIR CONDUCTION HEARING AID

K935867 is the FDA 510(k) clearance for AIR CONDUCTION 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 106-day FDA review.

K935867 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
106d
Days
Class 1
Risk

K935867 is an FDA 510(k) clearance for the AIR CONDUCTION HEARING AID, UNITRON IKON K & KD. 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 March 22, 1994 after a review of 106 days - within the typical 510(k) review window.

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 K935867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1993
Decision Date March 22, 1994
Days to Decision 106 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
17d slower than avg
Panel avg: 89d · This submission: 106d
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 K935867.
BELTONE ODE AND BELTONE ODE VX
K940103 · Beltone Electronics Corp. · Apr 1994
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP)
K940177 · Beltone Electronics Corp. · Apr 1994
OTOSONIC MINI PAS
K940104 · Beltone Electronics Corp. · Mar 1994
AIR CONDUCTION HEARING AID: IKON PP
K936106 · Unitron Industries, Inc. · Mar 1994
RIONET HEARING AID HB-53CI
K936122 · Authorized Hearing Systems, Inc. · Mar 1994
MIRACLE-EAR CONFIDANTE
K940458 · Miracle-Ear, Inc. · Mar 1994