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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

MED-EL Implant Systems Australasia Pty Ltd

Class:

AIMD

Manufactured by:

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

Therapeutic area:

35643 - Stimulator, electrical, auditory, cochlea

Therapeutic indications:

The Mi1250 Implant is the implantable part of the MED-EL Hearing 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 2 FLEX24 is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (EAS) of the auditory pathways for partially deaf individual

Authorization status:

A

Authorization date:

2020-08-06