510(k) DEN170009
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.