Mi1200 SYNCHRONY Cochlear Implant - Stimulator, electrical, auditory, cochlea

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Dostupné z:

MED-EL Implant Systems Australasia Pty Ltd

Trieda:

Class III

Výrobca:

Med-El Elektromedizinische Gerate GmbH Furstenweg 77a, Innsbruck, 6020 Austria

Terapeutické oblasti:

35643 - Stimulator, electrical, auditory, cochlea

Terapeutické indikácie:

The Mi1200 Implant is the implantable part of the MED-EL Cochlear Implant System and can only be used together with compatible MED-EL external components. The device consists of a stimulator, a coil with a removable magnet within its center, a reference electrode, an EAP reference electrode and an active electrode permanently attached to the stimulator. Also included in this system is an implant template that replicates the outline of the corresponding implant. 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 +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 variant SYNCHRONY +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.

Stav Autorizácia:

A

Dátum Autorizácia:

2022-05-24