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Hearing Preservation in Cochlear Implantation Surgery

RecruitingNAAges 18 Years - anyAllUMC Utrecht
NCT07146841 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a \*straight\* lateral wall lying electrode array (LW), or a \*pre-curved\* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. Our hypothesis is that the combination of a RW approach and a LW lying electro

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📋 Eligibility rules (as published)
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
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What it tests

  • Round window insertion
  • Cochleostomy insertion
  • Lateral wall array
  • Periomodiolar electrode array
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Where

1 site
University Medical Center Utrecht
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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