Evaluating a new cochlear implant for severe hearing loss
Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM SlimJ Electrode (Cl-1600-05) and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Cl-1601-05) (Ultra X) in Adults With Severe-to-profound Hearing Loss
This study is testing a new cochlear implant to see if it helps adults with severe hearing loss hear better compared to regular hearing aids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Bionics AG Industry-sponsored |
| Locations | 3 sites (Berlin and 2 other locations) |
| Trial ID | NCT04929470 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and performance of the HiRes Ultra Cl and HiRes Ultra 3D Cl cochlear implants in adults with severe-to-profound hearing loss. Participants will undergo unilateral cochlear implantation and will be monitored for adverse events while their speech perception abilities are evaluated before and after the procedure. The study will document any complications and compare the effectiveness of the implants against conventional hearing aids over a six-month follow-up period. The primary goal is to demonstrate a significant improvement in word recognition scores post-implantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with postlingual severe hearing loss who have limited benefit from hearing aids.
Not a fit: Patients with cochlear malformations or those who have had previous auditory implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hearing outcomes for patients with severe-to-profound hearing loss.
How similar studies have performed: Previous studies on cochlear implants have shown significant improvements in hearing outcomes, suggesting that this approach is well-supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Berlin and 2 other locations
- Unfallkrankenhaus Berlin (UKB) — Berlin, Germany (Recruiting)
- HNO-Klinik Düsseldorf — Düsseldorf, Germany (Recruiting)
- Westfälische Wilhelms-Universität Münster — Münster, Germany (Recruiting)
Study contacts
- Principal investigator: Arneborg Ernst, Prof. Dr. — Unfallkrankenhaus Berlin
- Study coordinator: Arneborg Ernst, Prof. Dr.
- Email: Arneborg.Ernst@ukb.de
- Phone: +49 (0) 30 56 81-4301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.