At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
Cochlear implantationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Investigation of the Safety and Performance of HiRes Ultra Cl HiFocus MS Electrode (Cl-1600-04) and HiRes Ultra 3D Cl HiFocus MS Electrode (Cl-1601-04) (Ultra X Implants) in Adults With Severe-to-profound Hearing Loss
In Brief
An observational study evaluating Cochlear implantation for Cochlear Hearing Loss. Completed, enrolled 30 participants across 3 sites.
Detailed Summary
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this device.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCochlear Hearing Loss
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedOct 2020
Primary CompletionMay 2025
TodayJul 2026
First PostedOct 30, 2020
Enrollment StartSep 16, 2020
Primary CompletionMay 21, 2025
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 5.7 years ago
Interventions
Cochlear implantationprocedure
patients receive a cochlear implantation within clinical routine