Cleared Traditional

SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL (K110831) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110831 · Sonitus Medical, Inc. · Ear, Nose, Throat device
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Jun 2011
Decision
88d
Days
Class 2
Risk

K110831 is an FDA 510(k) clearance for the SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL. 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 June 21, 2011 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sonitus Medical, Inc. devices

Submission Details

510(k) Number K110831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2011
Decision Date June 21, 2011
Days to Decision 88 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
1d faster than avg
Panel avg: 89d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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
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