RONDO Audio Processor - Stimulator, electrical, auditory, cochlea

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Køb det nu

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:

35643 - Stimulator, electrical, auditory, cochlea

Terapeutiske indikationer:

An external component of the MED-EL Cochlear Implant (CI) System, includes the RONDO audio processor and the audio processor accessories. In its basic configuration, the RONDO audio Processor consists of the control unit & battery pack. The FineTuner facilitates access to various audio processor functions. The RONDO is held in place by magnetic attraction over the implant. The RONDO is an audio processor and an external part of the MED-EL Cochlear Implant System. The MED-EL Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. Additionally, the MED-EL Cochlear Implant System used in combination with the FLEX24 electrode is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (EAS) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. The MED-EL Cochlear Implant System is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single?sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear.

Autorisation status:

A

Autorisation dato:

2014-01-06

Søg underretninger relateret til dette produkt