Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Cochlear Ltd - CI612 - Cochlear implant system electrode array assembly
ARTG entry for
Medical Device Included AIMD
1 University Avenue,MACQUARIE UNIVERSITY, NSW, 2109
ARTG Start Date
Medical Device AIMD
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
1 University Avenue
MACQUARIE UNIVERSITY, NSW, 2109
1. CI612 - Cochlear implant system electrode array assembly
Single Device Product
47373 Cochlear implant system electrode array assembly
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.
Nil variant (as 1 device) Nil
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Produced at 02.11.2019 at 06:20:14 AEDT
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