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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Insertion of the electrode array via the round window.
Insertion of the electrode array via cochleostomy.
Lateral wall electrode array from Advanced Bionics.
Perimodiolar MidScala electrode array from Advanced Bionics.
University Medical Center Utrecht
Utrecht, Netherlands
RECRUITINGHearing 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).
Time frame: 12 months
Scalar position of the electrode array
Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT)
Time frame: 12 months
Electrocochleography
ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials
Time frame: 12 months
Speech perception
Speech perception test with/without noise in CVC words correct score (in percentage) with signal to noise ratio of 10 dB.
Time frame: 12 months
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