NCT04777565

Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure

The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.

Detailed description

The cochlear implant (CI) is a neural prothesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation surgery 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 initially 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 large portions of the mastoid bone through a wide 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 efficacy of the HEARO robotic cochlear implantation surgery. Primary Objective The primary objective of this study is to: • explore the efficacy of a minimally invasive direct cochlear access via the HEARO procedure. Secondary Objectives The secondary objectives of this study are to: * explore the safety of a minimally invasive direct cochlear access via the HEARO procedure. * exploratively evaluate the electrode array insertion outcomes through the direct tunnel access.

Conditions

• Sensorineural Hearing Loss, Bilateral

Interventions

Type	Name	Description
OTHER	Robotic surgery	Cochlear implant surgery with HEARO procedure

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2021-03-02
• Last updated: 2023-02-21

Locations

1 site across 1 country: France