Preserving residual hearing during cochlear implant surgery.
Official title: Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial
Run by UMC Utrecht · NCT07146841 · Data updated 2026-11-12
This trial tests whether inserting the implant through the round window and using a straight lateral-wall electrode helps preserve remaining hearing in adults with severe sensorineural hearing loss who are receiving an Advanced Bionics cochlear implant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Status | Recruiting |
| Started | January 29, 2020 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | August 28, 2025 |
| Trial ID | NCT07146841 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (18+) with severe sensorineural hearing loss who are cochlear implant candidates, have normal middle ear function, speak Dutch, and choose an Advanced Bionics implant.
✕Probably not a fit
Patients with prior otologic surgery on the implanted ear, inner ear malformations, retrocochlear pathology, neurocognitive disorders, or sudden deafness are excluded and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with severe sensorineural hearing loss who are eligible for an Advanced Bionics cochlear implant will be assigned to surgical approaches using either round window insertion or cochleostomy and to electrode arrays that are either straight lateral-wall or pre-curved perimodiolar. Surgeons will perform the standard mastoidectomy-posterior tympanotomy approach and then use the assigned cochlear access and electrode type while aiming to minimize insertion trauma. Hearing preservation will be measured before and after implantation using audiometry and electrocochleography, with planned follow-up visits to track changes over time. The trial compares combinations of insertion route and electrode design to see which approach best minimizes cochlear trauma and preserves residual hearing.
Why it matters
Potential benefit: If successful, the approach could help patients retain more of their natural hearing after implantation, improving speech perception and sound quality.
How similar studies have gone: Prior research suggests less-traumatic insertion techniques and lateral-wall electrodes can help preserve residual hearing, but direct comparisons combining insertion route and electrode type remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Severe hearing loss, CI candidate * 18 years of age or older * normal function of middle ear (i.e. no acute middle ear infections) * dutch language proficiency * choice for Advanced Bionics implant Exclusion Criteria: * prior otologic surgery in the implanted ear (excluding tympanostomy tube placement) * inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation) * retrocochlear pathology present in the auditory system to be implanted * neurocognitive disorders * sudden deafness
Where it's running
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University Medical Center Utrecht
Utrecht, Netherlands Recruiting
Study contacts
- Principal investigator: Hans GXM Thomeer, MD, PhD — UMC Utrecht
- Study coordinator: Imogen AML van Beurden, MD
- Email: i.a.m.l.vanbeurden-5@umcutrecht.nl
- Phone: +31887555555
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.