Cleared Traditional

K231204 - Cochlear? Osia? System; Cochlear? Osia? OSI300 Implant; Cochlear? Magnet Cassette; Cochlear? Non-Magnetic Cassette; Cochlear? Osia? 2(I) Sound Processor; Cochlear? Osia? Fitting Software 2; Cochlear? Osia? Smart App
(FDA 510(k) Clearance)

K231204 · Cochlear · Ear, Nose, Throat

Aug 2023

Decision

113d

Days

Class 2

Risk

K231204 is an FDA 510(k) clearance for the Cochlear? Osia? System; Cochlear? Osia? OSI300 Implant; Cochlear? Magnet Cassette; Cochlear? Non-Magnetic Cassette; Cochlear? Osia? 2(I) Sound Processor; Cochlear? Osia? Fitting Software 2; Cochlear? Osia? Smart App. This device is classified as a Active Implantable Bone Conduction Hearing System (Class II — Special Controls, product code PFO).

Submitted by Cochlear (Centennial, US). The FDA issued a Cleared decision on August 18, 2023, 113 days after receiving the submission on April 27, 2023.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3340. 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..

Submission Details

510(k) Number	K231204 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 2023
Decision Date	August 18, 2023
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	PFO — Active Implantable Bone Conduction Hearing System
Device Class	Class II — 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.