Cleared Traditional

K132189 - OTOMAG BONE CONDUCATION HEARING SYSTEM

K132189 is an FDA 510(k) clearance for OTOMAG BONE CONDUCATION 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 130-day FDA review.

K132189 · Sophono, Inc. · Ear, Nose, Throat device
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Nov 2013
Decision
130d
Days
Class 2
Risk

K132189 is an FDA 510(k) clearance for the OTOMAG BONE CONDUCATION HEARING SYSTEM. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Sophono, Inc. (Boulder, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 130 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 - K132189

510(k) Number K132189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date November 22, 2013
Days to Decision 130 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
40d slower than avg
Panel avg: 90d · This submission: 130d
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 K132189.
Cordelle II Sound Processor
K150751 · Cochlear Americas · Jul 2015
Baha 5 Sound Processor
K142907 · Cochlear Americas · Mar 2015
PONTO PLUS AND PONTO PLUS POWER
K132775 · Oticon Medical AB · Dec 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K131240 · Cochlear Americas · Nov 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278 · Cochlear Americas · Sep 2013
OTOMAG BONE CONDUCTION HEARING SYSTEM
K123962 · Sophono, Inc. · Apr 2013