Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss

Launched by ADVANCED BIONICS AG · Oct 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of two types of cochlear implants, called the HiRes™ Ultra and the HiRes™ Ultra 3D Cl electrodes, for adults with severe-to-profound hearing loss. The goal is to see how well these devices work in real-life situations for people who have not had any previous hearing implants. Participants in this study will need to be at least 18 years old, have experienced significant hearing loss after learning to speak, and have not received much benefit from regular hearing aids.

To take part in this trial, individuals must meet specific criteria, such as scoring 60% or less on a hearing test with properly fitted hearing aids. They should also be comfortable communicating in German and willing to attend all scheduled appointments and procedures. Participants can expect to undergo surgery to implant the device and will be monitored closely to ensure their safety and track how well the implants are working over time. It's important to note that certain medical conditions or pregnancy may disqualify someone from participating in this study.

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.