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

Medical University of Vienna

Status: Unknown

Conditions: Deafness

Treatments: Procedure: HEARO Procedure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04795986

HEARO-AT

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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  • Invalid or withdrawn informed consent