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NCT03515473

Subjective and Objective Results With CI Electrode Types

Completed Last updated 3 May 2018
What this trial tests

trial testing cochlear implant in Cochlear Implant in 139 participants. Completed in 30 November 2017.

Timeline
13 November 2015
Primary endpoint
4 June 2017
30 November 2017

Quick facts

Lead sponsorSzeged University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment139
Start date13 November 2015
Primary completion4 June 2017
Estimated completion30 November 2017
Sites1 location across Hungary

Drugs / interventions tested

Conditions studied

Sponsor

Szeged University

Who can join

Eligibility, any sex, with Cochlear Implant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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