SONNET 2 Audio Processor - Cochlear implant system sound processor

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

下载 公众评估报告 (PAR)
08-08-2019

可用日期:

MED-EL Implant Systems Australasia Pty Ltd

类:

Class III

厂商:

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

治疗领域:

47374 - Cochlear implant system sound processor

疗效迹象:

An external component of the CI system supports electrical stimulation only. Battery powered BTE processor includes control unit with earhook attached, battery pack, coil & coil cable. The coil connects the processor with the implant. The integrated telecoil picks up magnetic sound signals from telephone receivers or loop systems installed in some public buildings & converts them into audible signals. FineTuner facilitates access to various processor functions. Multiple colour options available. The SONNET 2 audio processor is 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 or FLEX20 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. The Auditory Brainstem Implant (ABI) is used for electrical stimulation of the cochlear nucleus (CN) via an implanted stimulator and a specially designed electrode array to evoke auditory sensations in patients with non-functional cochlear nerves.

授权状态:

A

授权日期:

2019-07-01

搜索与此产品相关的警报