Hearing aid wireless-fitting computer-aided set

Australia - English - Department of Health (Therapeutic Goods Administration)

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Starkey Laboratories Australia Pty Ltd
Class 1
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Starkey Laboratories Australia Pty Ltd - Hearing aid wireless-fitting computer-aided set

ARTG entry for

Medical Device Included Class 1


Starkey Laboratories Australia Pty Ltd

Postal Address

PO Box 7305,ALEXANDRIA, NSW, 2015


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Starkey Laboratories Inc

6600 Washington Avenue South

Eden Prairie, MN, 55344

United States Of America


1. Hearing aid wireless-fitting computer-aided set

Product Type

Single Device Product

Effective date



57884 Hearing aid wireless-fitting computer-aided set

Intended purpose

A collection of devices designed to work in conjunction with a computer to transmit wireless data to a

hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by

healthcare personnel. It primarily consists of computer application software and a neck loop to establish

the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for

wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal

(CIC) types.

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 03.11.2017 at 04:49:37 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

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