Cochlear Hearing Loss Clinical Trial
Official title:
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including - Ultra Version V2 newly implanted on this side (Group 1) - Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2) - Informed consent signed Exclusion Criteria: - no exclusion criteria |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Medizinische Hochschule Hannover | Hannover |
| Lead Sponsor | Collaborator |
|---|---|
| Advanced Bionics AG |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Freiburger monosyllabic word recognition score in quiet in the implanted ear | Score obtained with the Freiburger Monosyllabic word test | 12 months after device activation |
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