Hearing Preservation in Cochlear Implantation Surgery
Recruiting now · Not applicable
Conditions studied: Sensorineural Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT07146841
- Run by
- UMC Utrecht
- People needed
- 48
- Starts
- 2020-01-29
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-08-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- University Medical Center Utrecht — Utrecht, Netherlands (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.