Evaluating a new fitting method for cochlear implants using robotic surgery
Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
This study is testing a new way to fit cochlear implants using advanced imaging to see if it helps people with severe hearing loss hear better after robotic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussel) |
| Trial ID | NCT05369598 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel fitting strategy for cochlear implants (CIs) that utilizes post-operative CT scans to create a personalized frequency-band distribution. The aim is to improve sound perception for patients with severe to profound sensorineural hearing loss who have undergone Robot Assisted Cochlear Implant Surgery (RACIS). Participants will be fitted with either a standard clinical approach or the new anatomy-based fitting (ABF) method, allowing for a comparison of audiological and quality of life outcomes. The study focuses on patients implanted with specific MED-EL cochlear implants and audio processors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with post-lingual severe to profound sensorineural hearing loss who have received a MED-EL cochlear implant via robotic surgery.
Not a fit: Patients who do not meet the eligibility criteria, such as those with pre-lingual hearing loss or those not implanted with the specified MED-EL devices, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved hearing outcomes and quality of life for cochlear implant recipients.
How similar studies have performed: While this specific approach is novel, similar studies exploring personalized fitting strategies for cochlear implants have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s) * Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS) * Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage * Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side * Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid) * Pre- operative and post-operative CT scan of the temporal bone available * Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available * Audio processor not yet activated on the newly implanted side * Minimum of 10 active channels can be activated * Fluent in the language of the test centre (Dutch or French) * Signed and dated ICF before the start of any study-specific procedure Exclusion Criteria: * Subject is a Single-Sided Deafness (SSD) CI user * Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor) * Lack of compliance with any inclusion criteria * Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Where this trial is running
Brussel
- UZ Brussel — Brussel, Belgium (Recruiting)
Study contacts
- Principal investigator: Vedat Topsakal, Prof. — Uzb-Vub
- Study coordinator: Emilie Heuninck
- Email: emilie.heuninck@uzbrussel.be
- Phone: 024749772
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.