Deafness
Conditions
Keywords
cochlear implantation, robotic surgery, automated inner ear access, automated middle ear access
Brief summary
To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.
Detailed description
The HEARO procedure involves a robot which drills the access to the cochlear in cochlear implantation. The study is an observational study of the first implementation in clinical routine in Austria.
Interventions
PROCEDUREHEARO Procedure
robotic access to the middle and inner ear in cochlear implantation
Sponsors
MED-EL Elektromedizinische Geräte GesmbH
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Exclusion criteria
* Age under 18 years * Pregnant women * Facial recess size does not allow a minimum distance of 0.4mm from the planned trajectory to the facial nerve and 0.3mm to the chorda tympani * Vulnerable or mentally retarded candidates * Invalid or withdrawn informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of cochlear access | at implantation | Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| electrode array insertion outcomes | at implantation | Percentage of patients with full electrode insertion (all contacts inside the cochlea) as assessed by postoperative DVT Imaging |
| Safety of cochlear access | at implantation | Number of patients with facial nerve paralysis after cochlear implantation as assessed by the House-Brackmann scale. |
Countries
Austria
Contacts
Primary ContactKliniksekretariat HNO Klinik
Outcome results
None listed