Subjective and Objective Results With CI Electrode Types

Completed

• Conditions: Cochlear Implant
• Interventions: Device: cochlear implant

• Registration Number: NCT03515473
• Lead Sponsor: Szeged University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-13
• Primary Completion: 2017-06-04
• Study Completion: 2017-11-30
• Study First Submitted: 2018-01-15
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-02
• Last Update Submitted: 2018-05-02
• Study First Posted: 2018-05-03
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

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

Exclusion Criteria

• unsuccessful cochlear implantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CI522	cochlear implant	Patients with CI522 cochlear implant
CI532	cochlear implant	Patients with CI532 cochlear implant
CI512	cochlear implant	Patients with CI512 cochlear implant

Primary Outcome Measures

Name	Time	Method
Intraoperative measurements	1 day	Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants

Secondary Outcome Measures

Name	Time	Method
Postoperative measurements	3 months	Power consumption of different types of cochlear implants

Trial Locations

Locations (1)

Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery; 🇭🇺 Szeged, Hungary