Summary for ARTG Entry:
Cochlear Ltd - Stimulator, electrical, auditory, cochlea
ARTG entry for
Medical Device Included (Export Only) Class 1
1 University Avenue,MACQUARIE UNIVERSITY, NSW, 2109
ARTG Start Date
Medical Device Class 1
- 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. Stimulator, electrical, auditory, cochlea
Single Device Product
35643 Stimulator, electrical, auditory, cochlea
The intended purpose of the Nucleus CI422 cochlear implant with staright electrode is the restoration of
hearing sensation via electrical stimulation of the auditory nerve to subjects with moderate to profound
hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies,
suitable for adults and children over the age of 12 months.
No Specific Conditions included on Record
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