Summary for ARTG Entry:
Cochlear Ltd - Nucleus CI551 Double Array Cochlear Implant - Stimulator, electrical, auditory, cochlea
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. Nucleus CI551 Double Array Cochlear Implant - Stimulator, electrical, auditory, cochlea
Single Device Product
35643 Stimulator, electrical, auditory, cochlea
The CI551 consists of a receiver/stimulator that receives and decodes the electrical signal from a sound
processor and two electrode arrays which deliver the signal to the cochlea.
Nucleus CI551 Double Array Cochlear Implant is intended to restore a level of auditory sensation via the
electrical stimulation of the auditory nerve.
Nil variant (as 1 device) Nil
No Specific Conditions included on Record
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