Using telemetry to improve cochlear implant outcomes
Prospective Study of Status Telemetry for Cochlear Implantations
Insel Gruppe AG, University Hospital Bern · NCT06223724
This study is testing a new way to use telemetry data to help doctors place cochlear implant electrodes more accurately, so people with hearing loss can hear better after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Bern) |
| Trial ID | NCT06223724 on ClinicalTrials.gov |
What this trial studies
This observational study explores the use of impedance telemetry data to estimate electrode positions in cochlear implants, aiming to provide a radiation-free alternative to traditional CT scans. By utilizing an advanced telemetry software designed for MED-EL cochlear implants, the study seeks to enhance the accuracy of electrode insertion depth measurements. The goal is to improve audiological outcomes for patients with sensorineural hearing loss by ensuring optimal electrode placement during surgery.
Who should consider this trial
Good fit: Ideal candidates include individuals scheduled for cochlear implant surgery who are receiving MED-EL cochlear implants and can provide informed consent.
Not a fit: Patients under 18 years of age or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better hearing restoration outcomes for patients receiving cochlear implants.
How similar studies have performed: While the use of telemetry in cochlear implants is a novel approach, similar studies have shown promise in improving surgical outcomes through advanced measurement techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent signed by the subject * Subjects scheduled for CI surgery according to clinical routine * Subjects who will receive a cochlear implant of the MED-EL portfolio (FLEX series arrays) * No radiological contraindications * Stated willingness to comply with all study procedures for the duration of the study Exclusion Criteria: * Lack of compliance with any inclusion criteria * Subjects incapable of giving informed consent * Age under 18 years * Pregnancy
Where this trial is running
Bern
- Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Marco Caversaccio, Prof. Dr. med. — Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
- Study coordinator: Stephan Schraivogel, MSc
- Email: stephan.schraivogel@unibe.ch
- Phone: +41 31 632 76 15
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.
Conditions: Sensorineural Hearing Loss