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OpenTrials
Completed

NCT Number: NCT03515473

Subjective and Objective Results With CI Electrode Types

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.

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Key information

Conditions

Cochlear Implant

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery

Szeged, 6725, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unsuccessful cochlear implantation

Treatment and study plan

Cochlear Implant

Device

cochlear implant surgery

Primary outcomes

  1. Intraoperative measurements

    Time frame: 1 day

    Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants.

  2. Intraoperative measurements

    Time frame: 1 day

    Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants

  3. Intraoperative measurements

    Time frame: 1 day

    Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants

Secondary outcomes

  1. Postoperative measurements

    Time frame: 3 months

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

  2. Postoperative measurements

    Time frame: 3 months

    Postoperative comfort level (C-level; current unit) with different types of cochlear implants

  3. Postoperative measurements

    Time frame: 3 months

    Power consumption of different types of cochlear implants

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 3, 2018
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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