N/A
Completed N=153
Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms
Source: ClinicalTrials.gov NCT03294681 ↗Enrolled (actual)
153
Serious AEs
1.3%
Results posted
Jun 2020
Primary outcomePrimary: Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over — 98.6 Percentage of ears
Summary
The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over |
98.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03294681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.