Cleared Traditional

K833486 - IN-THE-EAR HEARING AID MODEL

K833486 is an FDA 510(k) clearance for IN-THE-EAR HEARING AID MODEL, manufactured by Danavox, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K833486 · Danavox, Inc. · Ear, Nose, Throat device
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Jun 1984
Decision
259d
Days
Class 1
Risk

K833486 is an FDA 510(k) clearance for the IN-THE-EAR HEARING AID MODEL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Danavox, Inc. (Walker, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 259 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 Danavox, Inc. devices

FDA 510(k) Submission Details - K833486

510(k) Number K833486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1983
Decision Date June 22, 1984
Days to Decision 259 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 89d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K833486.
RIONET HEARING AID HI-03
K841935 · Rion Acoustic Instruments, Inc. · Aug 1984
CONFERETTE C2
K840893 · Siemens Hearing Instruments, Inc. · Aug 1984
OTICON E28A
K841436 · Oticon Corp. · Jun 1984
MCA IN THE EAR CUSTOM HEARING AID
K840298 · Maico Hearing Instruments, Inc. · Apr 1984
CANAL AID
K840165 · Qualitone · Apr 1984
CANAL HEARING AID
K833773 · Siemens Hearing Instruments, Inc. · Mar 1984