Hearing aid wireless-fitting computer-aided set

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

Buy It Now

Available from:
Starkey Laboratories Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
293417

Read the complete document

Public Summary

Summary for ARTG Entry:

293417

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

ARTG entry for

Medical Device Included Class 1

Sponsor

Starkey Laboratories Australia Pty Ltd

Postal Address

PO Box 7305,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

31/08/2017

Product category

Medical Device Class 1

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

Starkey Laboratories Inc

6600 Washington Avenue South

Eden Prairie, MN, 55344

United States Of America

Products

1. Hearing aid wireless-fitting computer-aided set

Product Type

Single Device Product

Effective date

31/08/2017

GMDN

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

Search alerts related to this product

Share this information