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The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study population | Subjects will need to be standard CI patients acording to national implant criteria and the study criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| CI aided word recognition scores in quiet and noise. | CI aided word recognition scores in quiet and noise. | 12 months post activation |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the potential of preservation of residual low frequency hearing | Evaluate the difference in Pure tone thresholds pre and post implantation in the low frequencies. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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individuals with severe-to-profound hearing loss
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| Name | Affiliation | Role |
|---|---|---|
| Johan Frijns, Prof Dr | LUMC - Department of ORL-HNS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Centre | Leiden | 2300 RC | Netherlands |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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