First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria (HEARO-AT)

To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.

Study Overview

• Status: Recruiting
• Conditions: Deafness
• Intervention / Treatment: Procedure: HEARO Procedure

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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Kliniksekretariat HNO Klinik; Phone Number: +43 1 40400 33760; Email: klinsek@push-email.at

Study Locations

• Austria
  • Wien
    • Vienna, Wien, Austria, 1090
      • Recruiting
      • HNO Klinik am AKH Wien
      • Contact: Kliniksekretariat HNO Klinik; Phone Number: +43 1 40400 33760; Email: klinsek@push-email.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.

Description

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  • Invalid or withdrawn informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of cochlear access	Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary)	at implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electrode array insertion outcomes	Percentage of patients with full electrode insertion (all contacts inside the cochlea) as assessed by postoperative DVT Imaging	at implantation
Safety of cochlear access	Number of patients with facial nerve paralysis after cochlear implantation as assessed by the House-Brackmann scale.	at implantation

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: MED-EL Elektromedizinische Geräte GesmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: robotic surgery; cochlear implantation; automated inner ear access; automated middle ear access
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: HEARO-AT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No