Cleared Traditional

K110831 - SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL

K110831 is an FDA 510(k) clearance for SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL, 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 88-day FDA review.

K110831 · Sonitus Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K110831

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 90d · This submission: 88d
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 K110831.
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278 · Cochlear Americas · Sep 2013
OTOMAG BONE CONDUCTION HEARING SYSTEM
K123962 · Sophono, Inc. · Apr 2013
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
K121793 · Audifon-USA, Inc. · Nov 2012
PONTO PRO POWER
K103594 · Oticon Medical AB · Jun 2011
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
K102199 · Sophono, Inc. · May 2011
BAHA 3 POWER SOUND PROCESSOR
K110996 · Cochlear Americas · May 2011