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Completed
NCT04929470
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
Conditions: Cochlear Hearing Loss
Sex: All
Ages: 18 Years – N/A
Enrollment: 37
Sponsor: Advanced Bionics AG
Location: HNO-Klinik Düsseldorf Düsseldorf Düsseldorf
Summary
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is approved for this device. Participants receive interventions as part of routine medical care.
Eligibility Criteria
Inclusion Criteria:
* No previous experience with any auditory implant
* 18 years of age or older
* Postlingual onset of severe hearing loss (≥ 4 years of age)
* Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test
* German language proficiency
* Willingness to participate in all scheduled procedures outlined in the protocol
Exclusion Criteria:
* Cochlear malformation or obstruction that would preclude full insertion of electrode array.
* Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
* Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures
* Evidence of central auditory lesion or compromised auditory nerve
* Pregnancy at time of surgery.
Source: ClinicalTrials.gov (NCT04929470). StuddyBuddy aggregates publicly available trial information.