Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM MS Electrode (Cl-1600-04) and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Cl-1601-04) (Ultra X Implants) in Adults With Severe-to-profound Hearing Loss
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM MS Electrode and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Ultra X) under normal conditions of use as it is approved for this device.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• 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
Locations
Other Locations
Germany
Heilig Geist Hospital Bensheim
RECRUITING
Bensheim
Unfallkrankenhaus Berlin (UKB
RECRUITING
Berlin
Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie
RECRUITING
Mannheim
Contact Information
Primary
Arneborg Ernst, Prof. Dr.
Arneborg.Ernst@ukb.de
+49 (0) 30 56 81-4301
Time Frame
Start Date: 2020-09-16
Estimated Completion Date: 2025-05
Participants
Target number of participants: 30
Related Therapeutic Areas
Sponsors
Leads: Advanced Bionics AG