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The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear implant (CI1032) | Participants implanted with a CI1032 |
| |
| Cochlear implant (CI1022) | Participants implanted with a CI1022 |
| |
| Cochlear implant (CI1012) | Participants implanted with a CI1012 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Nucleus Nexa Cochlear implant (CI1032) | Device | Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean within-participant change in the word recognition score in quiet | Percent correct word score from preimplantation to post-activation in the implanted ear. Score range: 0 to 100% correct, where a higher score is a better outcome. | Preimplantation to 6 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and device deficiencies | Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency | From enrolment to 12 months post-activation |
| Mean within-participant change in Speech Spatial Qualities questionnaire (SSQ-12) |
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Inclusion criteria:
Exclusion criteria:
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Post lingually deafened adult adults who are a candidate for cochlear implantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| cltd-prs-admin@cochlear.com PRS Specialist | Contact | 61 2 9428 6555 | cltd-prs-admin@cochlear.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Düsseldorf | Düsseldorf | 40225 | Germany |
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| Cochlear Nucleus Nexa Cochlear implant (CI1022) | Device | Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician |
|
| Cochlear Nucleus Nexa Cochlear implant (CI1012) | Device | Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician |
|
Speech, Spatial and Qualities of Hearing Scale Global Score (SSQ-12). Scores range from 0 to 10, where high scores indicate greater ability (less hearing disability). |
| Preimplantation to 3, 6 and 12 months post-activation |
| Mean within-participant change in word recognition score in quiet | Percent correct word score from preimplantation to post-activation in the implanted ear. Score range: 0 to 100% correct, where a higher score is a better outcome. | Preimplantation to 3 and 12 months post-activation. |
| Mean within-participant change in Living with Cochlear implants questionnaire (LivCI) | Living with Cochlear Implants Questionnaire (LivCI) evaluates the impact of a hearing device on four domains, Participation (range 0 to 12), Psychosocial & Wellbeing (range 0 to21), Stigma (range 0 to 15) and Management & Aesthetics (range 0 to 18), where a higher domain score indicates a positive patient report. | Preimplantation to 3, 6 and 12 months post-activation |
| Mean within-subject change in speech recognition threshold in noise | Speech reception threshold for a digit triplet test where 50% of the digits are correctly identified. The score upper limit is 20 dB, with no lower limit. A lower score indicates better performance. | 3, 6 and 12 months post-activation |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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