Cleared Special

TRANSEAR BONE CONDUCTION HEARING AID (K062404) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K062404 · Ear Technology Corp. · Ear, Nose, Throat device
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Sep 2006
Decision
22d
Days
Class 2
Risk

K062404 is an FDA 510(k) clearance for the TRANSEAR BONE CONDUCTION HEARING AID. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Ear Technology Corp. (Johnson City, US). The FDA issued a Cleared decision on September 8, 2006 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3302 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ear Technology Corp. devices

Submission Details

510(k) Number K062404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2006
Decision Date September 08, 2006
Days to Decision 22 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LXB Hearing Aid, Bone Conduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3302
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - LXB Hearing Aid, Bone Conduction

All 48
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