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Subjective and Objective Results With CI Electrode Types

Subjective and Objective Results With CI Electrode Types

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03515473
Enrollment
139
Registered
2018-05-03
Start date
2015-11-13
Completion date
2017-11-30
Last updated
2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Implant

Keywords

cochlear implant, CI532, CI512, CI522, electrode array, perimodiolar, electrophysiology

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.

Interventions

DEVICEcochlear implant

cochlear implant surgery

Sponsors

Szeged University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* unsuccessful cochlear implantation

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative measurements1 dayIntraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants.

Secondary

MeasureTime frameDescription
Postoperative measurements3 monthsPostoperative neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026