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Hearing Preservation in Cochlear Implantation Surgery

Key facts

Where
Utrecht, NetherlandsSee the site

Where in Netherlands

  • University Medical Center UtrechtUtrecht, NetherlandsContact: Hans GXM Thomeer, MD, PhDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
UMC Utrecht
Trial code
NCT07146841
Record updated
28 August 2025
Original description
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 electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.Read full original descriptionShow less

Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial

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 electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.

Inclusion: 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: prior otologic surgery in the implanted ear (excluding tympanostomy tube placement); neurocognitive disorders; 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; sudden deafness.

ClinicalTrials.gov NCT07146841