510(k) K191921
K191921 is an FDA 510(k) premarket notification submitted by Cochlear Americas for the device "Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments". The FDA issued a decision of Substantially Equivalent on November 15, 2019. The device falls under product code PFO (Active Implantable Bone Conduction Hearing System), a Class II device regulated under 21 CFR 874.3340. Cochlear Americas has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2019
- Date Received
- July 18, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Active Implantable Bone Conduction Hearing System
- Device Class
- Class II
- Regulation Number
- 874.3340
- Review Panel
- EN
- Submission Type
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.