Device Dossier

BCI 602 Lifts (1mm) - Implantable vibrator bone-conduction hearing implant system

Device Dossier for BCI 602 Lifts (1mm) - Implantable vibrator bone-conduction hearing implant system (Implantable vibrator bone-conduction hearing…

Intended purpose

The BCI 602 Lifts (1 mm) are intended to be used in combination with the Bonebridge Bone Conduction Implant (model BCI 602) to facilitate the fixation of the BC-FMT (Bone Conduction – Floating Mass Transducer) to the skull bone. BCI 602 Lifts (1 mm) are not mandatory for BCI 602 implantation. Whether to use them is the surgeon’s individual decision, which should be based on the anatomical situation of the particular patient.

Functional description

The BCI 602 Lifts (1mm) can be implanted together with the Bonebridge BCI 602. They can be attached to the wings of the BCI 602 and serve as a spacer to increase distance between the fixation wings and the skull bone. The BCI 602 Lifts (1mm) attached to the BCI 602 implant are fixed in the bone with two self-drilling cortical screws. An emergency screw may be used in case a self-drilling screw does not grab adequately.

TGA Public Summary