Cleared Traditional

K100649 - SOUNDBITE HEARING SYSTEM BY SONITUS

K100649 is an FDA 510(k) clearance for SOUNDBITE HEARING SYSTEM BY SONITUS, manufactured by Sonitus Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K100649 · Sonitus Medical, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jan 2011
Decision
312d
Days
Class 2
Risk

K100649 is an FDA 510(k) clearance for the SOUNDBITE HEARING SYSTEM BY SONITUS. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Sonitus Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sonitus Medical, Inc. devices

FDA 510(k) Submission Details - K100649

510(k) Number K100649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2010
Decision Date January 14, 2011
Days to Decision 312 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
222d slower than avg
Panel avg: 90d · This submission: 312d
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 K100649.
PONTO PRO POWER
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K102199 · Sophono, Inc. · May 2011
BAHA 3 POWER SOUND PROCESSOR
K110996 · Cochlear Americas · May 2011
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
K100360 · Cochlear Americas · Jul 2010
OTOMAG BONE CONDUCTION HEARING SYSTEM
K100193 · Sophono, Inc. · May 2010
PONTO PRO
K090996 · Oticon Medical AB · Jul 2009