Cleared Traditional

K102199 - OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)

K102199 is an FDA 510(k) clearance for OTOMAG BONE CONDUCTION HEARING SYSTEM M..., 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 292-day FDA review.

K102199 · Sophono, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
292d
Days
Class 2
Risk

K102199 is an FDA 510(k) clearance for the OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M). 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 23, 2011 after a review of 292 days - an extended review 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. 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 - K102199

510(k) Number K102199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2010
Decision Date May 23, 2011
Days to Decision 292 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
202d slower than avg
Panel avg: 90d · This submission: 292d
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 K102199.
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
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BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
K100360 · Cochlear Americas · Jul 2010