Subjective and Objective Results With CI Electrode Types

Study Overview
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Brief Summary
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Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor. Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold [ESRT], neural response telemetry threshold [T-NRT] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.

Official Title
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Subjective and Objective Results With CI Electrode Types

Conditions
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Cochlear Implant

Intervention / Treatment
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* Device: cochlear implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: successful cochlear implantation with CI532 or CI512 or CI522 gave informed consent Exclusion Criteria: unsuccessful cochlear implantation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CI532<br>Patients with CI532 cochlear implant | Device: cochlear implant<br>* cochlear implant surgery<br>|
| CI522<br>Patients with CI522 cochlear implant | Device: cochlear implant<br>* cochlear implant surgery<br>|
| CI512<br>Patients with CI512 cochlear implant | Device: cochlear implant<br>* cochlear implant surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative measurements | Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants. | 1 day | 
| Intraoperative measurements | Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants | 1 day | 
| Intraoperative measurements | Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative measurements | Postoperative neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants | 3 months | 
| Postoperative measurements | Postoperative comfort level (C-level; current unit) with different types of cochlear implants | 3 months | 
| Postoperative measurements | Power consumption of different types of cochlear implants | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant, CI532, CI512, CI522, electrode array, perimodiolar, electrophysiology