Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques

Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques

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.

Inclusion Criteria:

• Patients suffering from profound sensorineural deafness requiring a Cochlear implant

Exclusion Criteria:

• Age under 18 years
• Pregnant women
• Anatomical anomalies of temporal bone
• Chronic otitis media with or without cholesteatoma