Summary for ARTG Entry:
Advanced Bionics Australia Pty Ltd - HiRes 90K Advantage Cochlear Implant with HiFocus electrodes -
Stimulator, electrical, auditory, cochlea
ARTG entry for
Medical Device Included AIMD
Advanced Bionics Australia Pty Ltd
B2 / 12 Inglewood Place,BAULKHAM HILLS, NSW, 2153
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.
Advanced Bionics AG
1. HiRes 90K Advantage Cochlear Implant with HiFocus electrodes - Stimulator, electrical, auditory, cochlea
Single Device Product
35643 Stimulator, electrical, auditory, cochlea
The internal system components include a receiver and an electrode array that are implanted behind the
ear.The system converts sound into electrical energy that activates the auditory nerve and sends
information to the brain where its interpreted it as sound. The receiver stimulator encapsulates the
electronics in a titanium case, the antenna coil allows for telemetry between internal and external
components. The electrode array with 16 contacts is connected to the implant via the electrode lead
The HiResolution Bionic Ear System is intended to restore a level of auditory sensation to individuals with
severe-to-profound sensorineural hearing loss via electrical stimulation of the auditory nerve.
- 18 years of age or older.
- Severe-to-profound bilateral sensorineural hearing loss or severe-to profound unilateral hearing loss.
- Postlingual onset of severe or profound hearing loss.
- Limited benefit from appropriately fitted hearing aids, defined as scoring 50% or less on a test of open-set
sentence recognition (HINT Sentences).
- 12 months through 17 years of age.
- Severe-to-profound bilateral sensorineural deafness or severe-to-profound unilateral hearing loss.
- Use of appropriately fitted hearing aids for at least 6 months in children 2 through 17 years of age, or at
least 3 months in children 12 through 23 months of age. The minimum duration of hearing aid use is
waived if x-rays indicate ossification of the cochlea.
- Little or no benefit from appropriately fitted hearing aids.
Model number (see guidance docs) CI-1500-01
Shape (of tip) HiFocus Mid-Scala Electrode
Model number (see guidance docs) CI-1500-02H
Model number (see guidance docs) CI-1500-04
Shape (of tip) HiFocus Helix Electrode
Shape (of tip) HiFocus 1j Electrode
No Specific Conditions included on Record
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