H90.5
Conditions
Interventions
Group 1: Adult patients (m/f/d) aged 18 years or older who are medically indicated to be fitted with a cochlear implant. A Flex series electrode array from MED-EL is used for cochlear implantation. Th
Sponsors
Medizinische Hochschule Hannover, Klinik für Hals-Nasen-Ohrenheilkunde
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Adult patients (m/f/d) aged 18 years or older who are to be fitted with a CI due to medical indication - A MED-EL CI with a Flex series electrode array is to be implanted as part of a CI procedure - Consent for conventional CI surgery has already been obtained - Patients have acknowledged the study process, potential risks, and benefits, and consent after being informed. - Consent form must be signed. - Surgical clearance from the anesthesiologist under general anesthesia (ITN), analgesic sedation, or local anesthesia (LA)
Exclusion criteria
Exclusion criteria: - All subjects who do not meet the inclusion criteria - Patients in whom, in the surgeon's opinion, complete insertion of the selected electrode is not possible or planned (e.g., due to cochlear anatomy). - Patients with a narrow facial recess or other anatomical anomalies in the temporal bone region that, in the surgeon's intraoperative assessment, preclude the use of the Cochlear HydroDrive. - Children - Pregnant or breastfeeding women - Patients in palliative care - Individuals unable to consent due to acute illness - Individuals unable to consent due to chronic illness - Individuals in institutional care - Residents of a nursing home - Patients who do not provide written informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful insertion of the CI electrode at the insertion speed specified in the study up to the intended insertion depth | — |
Secondary
| Measure | Time frame |
|---|---|
| Impedances of the electrode contacts of the CI (intra-operative, 3 days post-operative, initial fitting) | — |
Countries
Germany
Contacts
Public ContactThomas Rau
Medizinische Hochschule Hannover
Outcome results
None listed