First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria

Deafness Clinical Trial

— HEARO-AT  

Official title:

First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795986
• Other study ID #: HEARO-AT
• Status: Recruiting
• Start date: September 17, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2021
• Source: Medical University of Vienna
• Contact: Kliniksekretariat HNO Klinik
• Phone: +43 1 40400 33760
• Email: klinsek[@]push-email.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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• Invalid or withdrawn informed consent

Related Conditions & MeSH terms

• Deafness

Intervention

Procedure:
• HEARO Procedure
robotic access to the middle and inner ear in cochlear implantation

Locations

Country	Name	City	State
Austria	HNO Klinik am AKH Wien	Vienna	Wien

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

Austria, 

Outcome

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