HiRes

Main information

  • Trade name:
  • HiRes 90K Advantage Cochlear Implant with HiFocus electrodes - Stimulator, electrical, auditory, cochlea
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • HiRes 90K Advantage Cochlear Implant with HiFocus electrodes - Stimulator, electrical, auditory, cochlea
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220306
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220306

Advanced Bionics Australia Pty Ltd - HiRes 90K Advantage Cochlear Implant with HiFocus electrodes -

Stimulator, electrical, auditory, cochlea

ARTG entry for

Medical Device Included AIMD

Sponsor

Advanced Bionics Australia Pty Ltd

Postal Address

B2 / 12 Inglewood Place,BAULKHAM HILLS, NSW, 2153

Australia

ARTG Start Date

20/02/2014

Product category

Medical Device AIMD

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

Advanced Bionics AG

Laubisrutistrasse 28

Stafa, 8712,

Switzerland

Products

1. HiRes 90K Advantage Cochlear Implant with HiFocus electrodes - Stimulator, electrical, auditory, cochlea

Product Type

Single Device Product

Effective date

20/07/2016

GMDN

35643 Stimulator, electrical, auditory, cochlea

Functional description

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

Intended purpose

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.

Adults

- 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).

Children

- 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.

Variant information

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

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 04:35:06 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