Hearing Preservation in Cochlear Implantation Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

48 Participants
are divided into 4 treatment groups

Sponsors and collaborators