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
This trial does not accept healthy volunteersQualifiers
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
Sequential
Treatments tested in this trial
Round window insertion
Procedure/SurgeryInsertion of the electrode array via the round window.
Cochleostomy insertion
Procedure/SurgeryInsertion of the electrode array via cochleostomy.
Lateral wall array
DeviceLateral wall electrode array from Advanced Bionics.
Periomodiolar electrode array
DevicePerimodiolar MidScala electrode array from Advanced Bionics.
Treatment groups
Trial outcomes
Primary outcomes
Hearing preservation
Hearing preservation is the main outcome, which will be expressed in percentage. Hearing preservation is calculated by using the preoperative and postoperative puretoneaudiometry (PTA).
Secondary outcomes
Scalar position of the electrode array
Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT)
Electrocochleography
ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials
Speech perception
Speech perception test with/without noise in CVC words correct score (in percentage) with signal to noise ratio of 10 dB.
Sponsors and contacts
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