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Hearing Preservation in Cochlear Implantation Surgery
Sponsor: UMC Utrecht
Summary
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.
Official title: Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2020-01-29
Completion Date
2027-01-01
Last Updated
2025-08-28
Healthy Volunteers
No
Conditions
Interventions
Round window insertion
Insertion of the electrode array via the round window.
Cochleostomy insertion
Insertion of the electrode array via cochleostomy.
Lateral wall array
Lateral wall electrode array from Advanced Bionics.
Periomodiolar electrode array
Perimodiolar MidScala electrode array from Advanced Bionics.
Locations (1)
University Medical Center Utrecht
Utrecht, Netherlands