Cleared Traditional

K191921 - Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (FDA 510(k) Clearance)

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

K191921 · Cochlear Americas · Ear, Nose, Throat device
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Nov 2019
Decision
120d
Days
Class 2
Risk

K191921 is an FDA 510(k) clearance for the Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting S.... Classified as Active Implantable Bone Conduction Hearing System (product code PFO), Class II - Special Controls.

Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on November 15, 2019 after a review of 120 days - within the typical 510(k) review window.

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 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 Cochlear Americas devices

Submission Details

510(k) Number K191921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2019
Decision Date November 15, 2019
Days to Decision 120 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
31d slower than avg
Panel avg: 89d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (PFO) and FDA review panel - the closest regulatory comparables to K191921.
Sentio Ti Implant Kit
K240614 · Oticon Medical AB · Jul 2024
Cochlear Osia System
K240155 · Cochlear Americas · Apr 2024
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
K220922 · Cochlear Americas · Jul 2022