Device Dossier

Mi1250 SYNCHRONY 2 PIN Cochlear Implant - Stimulator, electrical, auditory, cochlea

Device Dossier for Mi1250 SYNCHRONY 2 PIN Cochlear Implant - Stimulator, electrical, auditory, cochlea (Stimulator, electrical, auditory, cochlea, Class…

Intended purpose

The MED-EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. Additionally the MED-EL Cochlear Implant System used in combination with the implant variant SYNCHRONY 2 PIN FLEX24 is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (EAS) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. Additionally, the MED-EL Cochlear Implant System used in combination with the implant variants SYNCHRONY 2 PIN FLEX20 is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (EAS) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. The MED-EL Cochlear Implant System is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single–sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear.

Functional description

The Mi1250 PIN is the implantable part of the MED-EL Hearing Implant System and consists of a stimulator, a coil with a removable magnet within its centre, a reference electrode, an EAP reference electrode and an active electrode permanently attached to the stimulator. It features titanium fixation pins to secure the placement of the implant for stability. The corresponding implant template is provided with the Mi1250 PIN.

TGA Public Summary