Subjective and Objective Results With CI Electrode Types

May 2, 2018 updated by: László Rovó, Szeged University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Szeged, Hungary, 6725
        • Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects implanted with CI532 or CI512 or CI522 in Szeged and St. Pölten between the indicated time frames

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unsuccessful cochlear implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CI532
Patients with CI532 cochlear implant
Device: cochlear implant
cochlear implant surgery
CI522
Patients with CI522 cochlear implant
Device: cochlear implant
cochlear implant surgery
CI512
Patients with CI512 cochlear implant
Device: cochlear implant
cochlear implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative measurements
Time Frame: 1 day
Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants.
1 day
Intraoperative measurements
Time Frame: 1 day
Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants
1 day
Intraoperative measurements
Time Frame: 1 day
Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative measurements
Time Frame: 3 months
Postoperative neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants
3 months
Postoperative measurements
Time Frame: 3 months
Postoperative comfort level (C-level; current unit) with different types of cochlear implants
3 months
Postoperative measurements
Time Frame: 3 months
Power consumption of different types of cochlear implants
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2015

Primary Completion (Actual)

June 4, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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