Cleared Traditional

K153391 - Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

K153391 is an FDA 510(k) clearance for Sophono Bone Conduction Systems (S) Con..., 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 205-day FDA review.

K153391 · Sophono, Inc. · Ear, Nose, Throat device
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Jun 2016
Decision
205d
Days
Class 2
Risk

K153391 is an FDA 510(k) clearance for the Sophono Bone Conduction Systems (S) Configuration and (M) Configuration. 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 June 16, 2016 after a review of 205 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 - K153391

510(k) Number K153391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2015
Decision Date June 16, 2016
Days to Decision 205 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
115d slower than avg
Panel avg: 90d · This submission: 205d
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 K153391.
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