First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria

Medical University of Vienna10 enrolled

Overview

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

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

Conditions

Deafness

Interventions

HEARO ProcedurePROCEDURE

robotic access to the middle and inner ear in cochlear implantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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to the facial nerve and 0.3mm to the chorda tympani * Vulnerable or mentally retarded candidates * Invalid or withdrawn informed consent

Locations (1)

HNO Klinik am AKH Wien

Vienna, Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

efficacy of cochlear access

Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary)

Time frame: at implantation

Secondary Outcomes

electrode array insertion outcomes

Percentage of patients with full electrode insertion (all contacts inside the cochlea) as assessed by postoperative DVT Imaging

Time frame: at implantation

Safety of cochlear access

Number of patients with facial nerve paralysis after cochlear implantation as assessed by the House-Brackmann scale.

Time frame: at implantation

Central Contacts

Kliniksekretariat HNO Klinik

CONTACT

+43 1 40400 33760 klinsek@push-email.at

Data from ClinicalTrials.gov

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