Device Dossier
Sentio 1 Mini - Implantable vibrator bone-conduction hearing implant system
Device Dossier for Sentio 1 Mini - Implantable vibrator bone-conduction hearing implant system (Implantable vibrator bone-conduction hearing implant…
- GMDN category: Implantable vibrator bone-conduction hearing implant system
Intended purpose
The Sentio Sound Processor 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 Sound Processor is to pick up sound, process it and transmit the processed signal through the intact skin to the Sentio implant.
Functional description
The sound is picked up by the microphones in the external 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.