Evaluating the safety and performance of new cochlear electrodes for severe hearing loss
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
This study is testing new cochlear electrodes to see if they can safely improve hearing for adults with severe hearing loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Bionics AG Industry-sponsored |
| Locations | 3 sites (Bensheim, Hessen and 2 other locations) |
| Trial ID | NCT04610112 on ClinicalTrials.gov |
What this trial studies
This prospective observational study aims to assess the safety and effectiveness of the HiResTM Ultra Cl HiFocusTM MS Electrode and HiResTM Ultra 3D Cl HiFocusTM MS Electrode in adults with severe-to-profound hearing loss. Participants will undergo unilateral cochlear implantation and will be monitored for adverse events throughout the device's lifetime. The study will compare speech perception scores before and after implantation, with a focus on achieving at least a 20% improvement in word recognition six months post-activation. Data will be collected according to clinical routine, ensuring a comprehensive evaluation of the device's performance.
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, additional disabilities, or medical conditions that contraindicate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve speech perception and quality of life for patients with severe-to-profound hearing loss.
How similar studies have performed: Previous studies have shown positive outcomes with similar cochlear implantation approaches, indicating potential for success in this study.
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
Bensheim, Hessen and 2 other locations
- Heilig Geist Hospital Bensheim — Bensheim, Hessen, Germany (Recruiting)
- Unfallkrankenhaus Berlin (UKB — Berlin, Germany (Recruiting)
- Klinik für HNO-Heilkunde. Kopf- imd Halschirurgie — Mannheim, 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.