Cleared Special

K062404 - TRANSEAR BONE CONDUCTION HEARING AID

K062404 is an FDA 510(k) clearance for TRANSEAR BONE CONDUCTION HEARING AID, manufactured by Ear Technology Corp.. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Special 510(k) pathway after a 22-day FDA review.

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

FDA 510(k) Submission Details - K062404

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 90d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

LXB Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K062404.
COCHLEAR BAHA BP100
K090720 · Cochlear Bone Anchored Systems AB · Jun 2009
OBC BONE ANCHORED HEARING AID SYSTEM
K082108 · Oticon Medical AB · Nov 2008
BAHA INTENSO
K081606 · Cochlear Americas · Aug 2008
TRANSEAR BONE CONDUCTION HEARING AID
K050653 · United Hearing Systems, Inc. · Jul 2005
BAHA DIVINO
K042017 · Entific Medical Systems, Inc. · Aug 2004
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
K992872 · Entific Medical Systems, Inc. · Nov 1999