To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
* Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults. * Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation. * Validate the system and procedure safety mechanisms. * Collect required data for validation of safety algorithms and procedure workflow optimisation. * Validate the HEARO system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Robotic system for otological procedures
Antwerp University Hospital
Antwerp, Belgium
The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.
Time frame: Image data aquired during the procedure
Number of completed middle ear access
Time frame: The procedure (day 0)
Number of completed inner ear access
Time frame: The procedure (day 0)
Accuracy of the drilled trajectory
Time frame: Image data aquired during the procedure
Sensitivity and specificity of facial nerve monitoring
Time frame: The procedure (day 0)
Measurement of the insertion angle
Measurement of the insertion depth of the electrode into the Cochlea
Time frame: Image data aquired during the procedure
Number of tip fold-overs
Time frame: The procedure (day 0)
Number of Scala deviations
Time frame: The procedure (day 0)
Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection
Time frame: day 0-30
Time of procedure
Time frame: The procedure (day 0)
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Volume of tissue removed
Time frame: Image data aquired during the procedure