Cleared Traditional

K082108 - OBC BONE ANCHORED HEARING AID SYSTEM

K082108 is an FDA 510(k) clearance for OBC BONE ANCHORED HEARING AID SYSTEM, manufactured by Oticon Medical AB. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K082108 · Oticon Medical AB · Ear, Nose, Throat device
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Nov 2008
Decision
112d
Days
Class 2
Risk

K082108 is an FDA 510(k) clearance for the OBC BONE ANCHORED HEARING AID SYSTEM. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Oticon Medical AB (Gothenburg, Askim, SE). The FDA issued a Cleared decision on November 14, 2008 after a review of 112 days - within the typical 510(k) review window.

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. 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 Oticon Medical AB devices

FDA 510(k) Submission Details - K082108

510(k) Number K082108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2008
Decision Date November 14, 2008
Days to Decision 112 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
22d slower than avg
Panel avg: 90d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 51
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K082108.
OTOMAG BONE CONDUCTION HEARING SYSTEM
K100193 · Sophono, Inc. · May 2010
PONTO PRO
K090996 · Oticon Medical AB · Jul 2009
COCHLEAR BAHA BP100
K090720 · Cochlear Bone Anchored Systems AB · Jun 2009
BAHA INTENSO
K081606 · Cochlear Americas · Aug 2008
TRANSEAR BONE CONDUCTION HEARING AID
K062404 · Ear Technology Corp. · Sep 2006
TRANSEAR BONE CONDUCTION HEARING AID
K050653 · United Hearing Systems, Inc. · Jul 2005