Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss

Launched by ADVANCED BIONICS AG · Jun 10, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of two types of cochlear implants, called the HiRes Ultra and HiRes Ultra 3D with SlimJ Electrode, for adults with severe to profound hearing loss. The goal is to see how well these devices work in everyday situations for people who have struggled with traditional hearing aids. If you are an adult aged 18 or older who has experienced significant hearing loss for a while and hasn't had success with hearing aids, you might be eligible to participate.

Participants in this study will receive the cochlear implant as part of their regular medical care. To join, you should be comfortable with the German language and be willing to follow the study's procedures. However, if you have certain medical conditions, previous ear surgeries, or if you're pregnant, you may not be able to take part. This trial is currently recruiting participants, and it aims to provide valuable information about improving hearing for those who need it most.

Gender

ALL

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.