The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Sensorineural Hearing Loss

Treatments

Device: HEARO

Device: OTOPLAN

Study type

Interventional

Funder types

Other

Identifiers

NCT04610450

RCI-NEXT

Details and patient eligibility

About

The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects scheduled for CI surgery according to clinical routine
Subjects who will receive a cochlear implant
Signed and dated informed consent form

Exclusion criteria

Lack of compliance with any inclusion criteria
Age under 18 years
Pregnancy
Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT scan
Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening CT scan
A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
Individuals where image guidance or robotic procedures are not indicated