NCT03515473

Subjective and Objective Results With CI Electrode Types

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 139 (actual)
• Sponsor: Szeged University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cochlear Implant

Interventions

Type	Name	Description
DEVICE	cochlear implant	cochlear implant surgery

Timeline

• Start date: 2015-11-13
• Primary completion: 2017-06-04
• Completion: 2017-11-30
• First posted: 2018-05-03
• Last updated: 2018-05-03

Locations

1 site across 1 country: Hungary

Regulatory

• FDA-regulated device study