Device Dossier
Sentio Ti Implant Kit - Implantable vibrator bone-conduction hearing implant system
Device Dossier for Sentio Ti Implant Kit - Implantable vibrator bone-conduction hearing implant system (Implantable vibrator bone-conduction hearing…
- GMDN category: Implantable vibrator bone-conduction hearing implant system
Intended purpose
The Sentio Ti implant is intended for improvement of hearing for patients with conductive or mixed losses, whether unilaterally or bilaterally fitted, or for those with single sided deafness. The intended purposes of the Sentio Ti implant is to be surgically placed in the temporal and mastoid bone area. It is intended to retain the sound processor, receive signals from the sound processor, transform signals into vibrations and transmit the vibrations via skull bone to the inner ear.
Functional description
The sound is picked up by the microphones in the sound processor, processed and transmitted using a radio frequency (RF) link through the intact skin to an implant placed in the temporal and mastoid bone area. The receiver coil of the implant receives the signal that is converted into mechanical energy (vibrations) by the transducer. The vibrations are conveyed from the bottom of the transducer to the skull and thereafter by means of bone conduction to the cochlea.