NCT04610450

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sensorineural Hearing Loss

Interventions

Type	Name	Description
DEVICE	HEARO	Robotic system for otological procedures
DEVICE	OTOPLAN	Otological surgical planning software

Timeline

• Start date: 2021-04-26
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2020-10-30
• Last updated: 2022-11-25

Locations

1 site across 1 country: Switzerland