Not Cleared Direct

Bonebridge (DEN170009) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170009 · Med-El Elektromedizinische Geraete GmbH · Ear, Nose, Throat device
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Jul 2018
Decision
522d
Days
Class 2
Risk

DEN170009 is an FDA 510(k) submission (not cleared) for the Bonebridge. Classified as Active Implantable Bone Conduction Hearing System (product code PFO), Class II - Special Controls.

Submitted by Med-El Elektromedizinische Geraete GmbH (Innsbruck, AT). The FDA issued a Not Cleared (DENG) decision on July 20, 2018 after a review of 522 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3340 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 522 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Med-El Elektromedizinische Geraete GmbH devices

Submission Details

510(k) Number DEN170009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 13, 2017
Decision Date July 20, 2018
Days to Decision 522 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
433d slower than avg
Panel avg: 89d · This submission: 522d
Pathway characteristics

Device Classification

Product Code PFO Active Implantable Bone Conduction Hearing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3340
Definition An Active Implantable Bone Conduction Hearing System Is A Prescription Device Consisting Of An Implanted Transducer, Implanted Electronics Components, And An Audio Processor. The Active Implantable Bone Conduction Hearing System Is Intended To Compensate For Conductive Or Mixed Hearing Losses By Conveying Amplified Acoustic Signals To The Cochlea Via Mechanical Vibrations On The Skull Bone.
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 - PFO Active Implantable Bone Conduction Hearing System

All 10
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