Bone Conduction Implant Kit, BCI 602 Kit - Implantable vibrator bone-conduction hearing implant system

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

MED-EL Implant Systems Australasia Pty Ltd

Klass:

Class III

Tillverkad av:

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

Terapiområde:

61176 - Implantable vibrator bone-conduction hearing implant system

Terapeutiska indikationer:

The Bone Conduction Implant is the implantable part of the Bonebridge system. The device is a direct-drive implantable hearing prosthesis, intended to provide a useful level of sound perception for individuals with CHL and MHL, as well as for those suffering from single sided deafness. The BCI 602 is surgically implanted into the temporal bone. The kit contains 1 BCI 602 implant kit and 1 BCI 602 Sizer Kit. The Bonebridge system with the Bone Conduction Implant BCI 602 is intended to treat patients with either conductive or mixed hearing loss or patients suffering from single sided sensorineural deafness. The Bonebridge with the BCI 602 augments hearing by providing acoustic information to the inner ear via bone conduction. This is achieved by actuating a vibratory transducer, which is implanted in the temporal bone. The BCI 602 is for patients 5 (five) years of age or older.

Bemyndigande status:

A

Tillstånd datum:

2022-05-24