Actively Recruiting
Hearing Preservation in Cochlear Implantation Surgery
Led by UMC Utrecht · Updated on 2025-08-28
48
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hearing Preservation in Cochlear Implantation Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe hearing loss, candidate for cochlear implant
- 18 years of age or older
- Normal middle ear function with no acute middle ear infections
- Proficient in Dutch language
- Choice for Advanced Bionics implant
You will not qualify if you...
- Prior ear surgery in the implanted ear (excluding tympanostomy tube placement)
- Presence of inner ear malformation in the ear to be implanted (e.g., ossification, Mondini malformation)
- Retrocochlear pathology in the auditory system of the implanted ear
- Neurocognitive disorders
- Sudden deafness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
I
Imogen AML van Beurden, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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