Summary for ARTG Entry:
MED-EL Implant Systems Australasia Pty Ltd - RONDO Audio Processor - Stimulator, electrical, auditory,
ARTG entry for
Medical Device Included Class III
MED-EL Implant Systems Australasia Pty Ltd
Level 2 Suite 2-07,90-96 Bourke Road,ALEXANDRIA, NSW, 2015
ARTG Start Date
Medical Device Class III
- 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.
Med-El Elektromedizinische Geraete GmbH
Innsbruck, , 6020
1. RONDO Audio Processor - Stimulator, electrical, auditory, cochlea
Medical device system
35643 Stimulator, electrical, auditory, cochlea
An external component of the MED-EL Cochlear Implant (CI) System, includes the RONDO audio
processor and the audio processor accessories. In its basic configuration, the RONDO audio Processor
consists of the control unit & battery pack. The FineTuner facilitates access to various audio processor
functions. The RONDO is held in place by magnetic attraction over the implant.
The RONDO is an audio processor and an external part of the MED-EL Cochlear Implant System. The
MED-EL Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of the
auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit
from acoustic amplification in the best aided condition.
Additionally, the MED-EL Cochlear Implant System used in combination with the FLEX24 electrode is
intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic
stimulation (EAS) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic
amplification in the lower frequencies only.
The MED-EL Cochlear Implant System is also intended to evoke auditory sensations via electrical
stimulation of the auditory pathways for individuals with single±sided deafness, which is defined as severe
to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in
the other ear.
Nil variant (as 1 device) Colour only -
No Specific Conditions included on Record
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