CI612 - Cochlear implant system electrode array assembly

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
01-11-2019

Dostopno od:

Cochlear Ltd

Razred:

AIMD

Izdeluje:

Cochlear Ltd 1 University Avenue, MACQUARIE UNIVERSITY, NSW, 2109 Australia

Terapevtsko območje:

47373 - Cochlear implant system electrode array assembly

Terapevtske indikacije:

The CI612 cochlear implant is implanted in the mastoid region of either side or both sides of the head. The cochlear implant receives electrical power and data from an external sound processor via electromagnetic induction to the coil. The implanted magnet ensures that the external sound processor is correctly attached and aligned relative to the implant coil. Intended for restoration of hearing sensation by electrical stimulation of the auditory nerve in patients with moderately severe to profound sensorineural hearing loss.

Status dovoljenje:

A

Datum dovoljenje:

2019-08-22

Opozorila o iskanju, povezana s tem izdelkom