Australia - English - Department of Health (Therapeutic Goods Administration)
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
PO Box 7305,ALEXANDRIA, NSW, 2015
ARTG Start Date
Medical Device Class 1
- 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
Single Device Product
57884 Hearing aid wireless-fitting computer-aided set
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
No Specific Conditions included on Record
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Produced at 03.11.2017 at 04:49:37 AEDT
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