Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms

Overview

The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.

Full Title of Study: “Trans-impedance Matrix”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 29, 2019

Interventions

  • Device: Objective measures with CSEP
    • Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients

Arms, Groups and Cohorts

  • Cochlear Implant Recipients

Clinical Trial Outcome Measures

Primary Measures

  • Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over
    • Time Frame: at surgery, within one minute
    • Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery. Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.

Participating in This Clinical Trial

Inclusion Criteria

  • Candidate for cochlear implantation with the CI532 or CI512 devices – 18 years of age or older at the time of enrolment – Normal cochlea anatomy, established via pre-operative Computer Tomography – Willingness to participate in and to comply with all requirements of the protocol Exclusion Criteria:

  • Prior cochlear implantation in the ear to be implanted – Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array – Abnormal cochlear anatomy on pre-operative Computer Tomography or Magnetic Resonance Imaging – Additional handicaps that would prevent participation in evaluations – Pregnant and breast feeding women, prisoners, or anyone in custody – Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cochlear
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bart Volckaerts, PhD, Study Director, Cochlear

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.