Sensorineural Hearing Loss
Conditions
Keywords
robot, Image guidance, Cochlear implantation, navigation, HEARO procedure, sensorineural hearing loss, inner ear access
Brief summary
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.
Detailed description
* 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.
Interventions
DEVICEHEARO
Robotic system for otological procedures
Sponsors
Prof. Vedat Topsakal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Image data aquired during the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of completed inner ear access | The procedure (day 0) | — |
| Accuracy of the drilled trajectory | Image data aquired during the procedure | — |
| Sensitivity and specificity of facial nerve monitoring | The procedure (day 0) | — |
| Measurement of the insertion angle | Image data aquired during the procedure | Measurement of the insertion depth of the electrode into the Cochlea |
| Number of completed middle ear access | The procedure (day 0) | — |
| Number of Scala deviations | The procedure (day 0) | — |
| Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection | day 0-30 | — |
| Time of procedure | The procedure (day 0) | — |
| Volume of tissue removed | Image data aquired during the procedure | — |
| Number of tip fold-overs | The procedure (day 0) | — |
Countries
Belgium
Outcome results
None listed