Subjective and Objective Results With CI Electrode Types

University of Szeged (SZTE)

Status: Completed

Conditions: Cochlear Implant

Treatments: Device: cochlear implant

Study type: Observational

Funder types: Other

Identifiers

NCT03515473

CI-001

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• successful cochlear implantation with CI532 or CI512 or CI522
• gave informed consent

Exclusion criteria

• unsuccessful cochlear implantation

Trial design

139 participants in 3 patient groups

CI532

Description:

Patients with CI532 cochlear implant

Treatment:

Device: cochlear implant

CI522

Description:

Patients with CI522 cochlear implant

Treatment:

Device: cochlear implant

CI512

Description:

Patients with CI512 cochlear implant

Treatment:

Device: cochlear implant