Analysis of speech performance in cochlear implant users
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
This study looks at how well people with HiRes Ultra and HiRes Ultra 3D cochlear implants can understand speech to see if these devices really help improve their hearing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Advanced Bionics AG Industry-sponsored |
| Locations | 1 site (Hannover) |
| Trial ID | NCT06301581 on ClinicalTrials.gov |
What this trial studies
This observational study aims to retrospectively analyze speech perception results from users of the HiRes Ultra and HiRes Ultra 3D cochlear implants. It will collect data on the performance of these devices as measured in clinical settings. The study focuses on both newly implanted users and those who have transitioned from an older version of the device due to failure. By evaluating real-world outcomes, the study seeks to confirm the effectiveness of these cochlear implants in improving speech performance.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who are unilateral or bilateral users of HiRes Ultra or HiRes Ultra 3D cochlear implants.
Not a fit: Patients who do not use HiRes Ultra or HiRes Ultra 3D cochlear implants may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of HiRes Ultra cochlear implants, potentially leading to improved patient outcomes in hearing restoration.
How similar studies have performed: Other studies have shown success in analyzing cochlear implant performance, making this approach a continuation of established research in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including * Ultra Version V2 newly implanted on this side (Group 1) * Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2) * Informed consent signed Exclusion Criteria: * no exclusion criteria
Where this trial is running
Hannover
- Medizinische Hochschule Hannover — Hannover, Germany (Recruiting)
Study contacts
- Principal investigator: Andreas Büchner — Hannover Medical School
- Study coordinator: Andreas Büchner, Prof
- Email: buechner.andreas@mh-hannover.de
- Phone: 49 511 532 8589
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.