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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CI532 | Patients with CI532 cochlear implant |
| |
| CI522 | Patients with CI522 cochlear implant |
| |
| CI512 | Patients with CI512 cochlear implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cochlear implant | Device | cochlear implant surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects implanted with CI532 or CI512 or CI522 in Szeged and St. Pölten between the indicated time frames
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery | Szeged | 6725 | Hungary |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| 3 months |
| Postoperative measurements | Power consumption of different types of cochlear implants | 3 months |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |