Vibrating Ossicular Prosthesis ? VORP 503 Implant Kit - Partially-implantable middle ear implant system

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

MED-EL Implant Systems Australasia Pty Ltd

Klasse:

Class III

Fremstillet af:

Med-El Elektromedizinische Gerate GmbH Furstenweg 77a, Innsbruck, 6020 Austria

Terapeutisk område:

30084 - Partially-implantable middle ear implant system

Terapeutiske indikationer:

The VORP 503 is the implanted part of the Vibrant Soundbridge System, surgically implanted into the temporal bone under the skin. It is designed to be used with a Vibroplasty Coupler, as decided by the surgeon, when attaching the FMT to a vibratory structure of the ear, or alone, when placing the FMT directly at the round window. When activated, the FMT vibrates in a controlled manner causing the structure of the middle ear to vibrate. These vibrations are interpreted by the patient as sound. The Vibrant Soundbridge VORP 503 Implant Kit contains one implant VORP 503 and other items. The VORP 503 is the implanted part of the Vibrant Soundbridge System. It is an active implant, which is implanted into the temporal bone under the skin during a surgical procedure. The VORP 503 is designed to be used with one of the Vibroplasty Couplers, as decided by the surgeon, when attaching the FMT to a vibratory structure of the ear, or alone, when placing the FMT directly at the round window. This treatment of hearing loss via vibratory stimulation in the middle ear is called Vibroplasty. The Vibrant Soundbridge is indicated for use in patients who have mild to severe hearing impairment and cannot achieve success or adequate benefit from traditional therapy.

Autorisation status:

A

Autorisation dato:

2022-05-24