RONDO

Main information

  • Trade name:
  • RONDO Audio Processor - Stimulator, electrical, auditory, cochlea
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • RONDO Audio Processor - Stimulator, electrical, auditory, cochlea
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218934
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218934

MED-EL Implant Systems Australasia Pty Ltd - RONDO Audio Processor - Stimulator, electrical, auditory,

cochlea

ARTG entry for

Medical Device Included Class III

Sponsor

MED-EL Implant Systems Australasia Pty Ltd

Postal Address

Level 2 Suite 2-07,90-96 Bourke Road,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

6/01/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Med-El Elektromedizinische Geraete GmbH

Fuerstenweg 77a

Innsbruck, , 6020

Austria

Products

1. RONDO Audio Processor - Stimulator, electrical, auditory, cochlea

Product Type

Medical device system

Effective date

6/01/2014

GMDN

35643 Stimulator, electrical, auditory, cochlea

Functional description

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.

Intended purpose

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.

Variant information

Nil variant (as 1 device) Colour only -

Anthracite/Ebony/Nordic grey/Creme

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 09:00:45 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

7-11-2018

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