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The goal of this clinical trial is to test the Mi2000 Totally Implantable Cochlear Implant in a population of candidates for a cochlear implant. The main question it aims to answer is, whether the device is able to improve speech perception compared to the pre-operative score.
Participants will undergo cochlear implantation and fitting, and will be asked to perform the following tests pre- and post-operatively:
Full description
Cochlear implants (CI) provide a large majority of recipients with a significant degree of speech understanding. However, CI systems rely on external audio processors to function. This can have several disadvantages: for instance, the hardware is exposed to external trauma and to the effects of head movement and gravity. The device is also put at risk by humid, dusty, or dirty conditions as well as by physical activities that lead to water exposure such as swimming or sports in general (e.g. perspiration).
In addition, some patients are concerned with the cosmetic appearance of the external parts which are visible (more so than modern behind-the-ear hearing aids), something that may not be desirable to many potential candidates.
This clinical investigation aims to collect confirmatory data on the use of the Mi2000 Totally Implantable Cochlear Implant system used in combination with compatible devices.
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30 participants in 1 patient group
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Central trial contact
Florian Schwarze, PhD
Data sourced from clinicaltrials.gov
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