Cleared Traditional

K100193 - OTOMAG BONE CONDUCTION HEARING SYSTEM

K100193 is an FDA 510(k) clearance for OTOMAG BONE CONDUCTION HEARING SYSTEM, manufactured by Sophono, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K100193 · Sophono, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
116d
Days
Class 2
Risk

K100193 is an FDA 510(k) clearance for the OTOMAG BONE CONDUCTION HEARING SYSTEM. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Sophono, Inc. (Lakewood, US). The FDA issued a Cleared decision on May 18, 2010 after a review of 116 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 Sophono, Inc. devices

FDA 510(k) Submission Details - K100193

510(k) Number K100193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2010
Decision Date May 18, 2010
Days to Decision 116 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 90d · This submission: 116d
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 48
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K100193.
BAHA 3 POWER SOUND PROCESSOR
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K100360 · Cochlear Americas · Jul 2010
PONTO PRO
K090996 · Oticon Medical AB · Jul 2009
COCHLEAR BAHA BP100
K090720 · Cochlear Bone Anchored Systems AB · Jun 2009
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K082108 · Oticon Medical AB · Nov 2008