The study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2 years, evaluating both subjective (patients reported) and objective outcomes over time. For the audiological part of the study both pure-tone and speech audiometry results will be held against the patient perceived benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular part of the study will evaluate the function of the SCCs and the sacculus. This is will be put in concert with functional tests of the vestibular system, and the patient perceived outcome measure DHI. Correlations between vestibular and audiological performances will be examined. A collection of specific hypotheses will be tested by predefined statistical methods.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Anticipated increase in speech audiometric performances
Timeframe: +24 months from last inclusion. Expected to be complete in juli 2025.
Anticipated increase in patient reported outcome measures
Timeframe: +24 months from last inclusion. Expected to be complete in juli 2025.
Test-retest assessment of vestibular screening battery
Timeframe: Conducted before cochlear implantation in all patients.