510(k) DEN170009
DEN170009 is an FDA 510(k) premarket notification submitted by Med-El Elektromedizinische Geraete GmbH for the device "Bonebridge". The FDA issued a decision of De Novo Granted on July 20, 2018. The device falls under product code PFO (Active Implantable Bone Conduction Hearing System), a Class II device regulated under 21 CFR 874.3340. Med-El Elektromedizinische Geraete GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 20, 2018
- Date Received
- February 13, 2017
- Clearance Type
- Direct
- 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.