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

NCT ID: NCT04777565

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2023-01-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CI surgery

cochlear implant surgery

Group Type: EXPERIMENTAL

Robotic surgery

Intervention Type: OTHER

Cochlear implant surgery with HEARO procedure

Interventions

Robotic surgery

Cochlear implant surgery with HEARO procedure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects scheduled for CI surgery according to clinical routine
• Subjects who will receive a cochlear implant of the MED-EL portfolio
• Signed and dated informed consent form

• 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
• Individuals who have known allergy to components of the cochlear implant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MED-EL Elektromedizinische Geräte GesmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Venail, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

CHU Montpellier

Montpellier, , France

Countries

France

References

Fourez AL, Kaderbay A, Villerabel C, Korchagina J, Pean V, Mondain M, Venail F. Implementation of Robot-Assisted Minimally Invasive Cochlear Implantation: A Feasibility Study. Otol Neurotol. 2025 Aug 1;46(7):809-815. doi: 10.1097/MAO.0000000000004531. Epub 2025 May 23.

Reference Type: DERIVED

PMID: 40423721 (View on PubMed)

Other Identifiers

MED-EL_HEARO_french_study

Identifier Type: -

Identifier Source: org_study_id