The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure (ARCI25)

Prof. Vedat Topsakal

Status: Unknown

Conditions: Sensorineural Hearing Loss

Treatments: Device: OTOPLAN; Device: HEARO

Study type: Interventional

Funder types: Other

Identifiers

NCT04102215

000523

Details and patient eligibility

About

To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ 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
• Pregnancy
• Distance of the planned trajectory to the facial nerve is < 0.4mm
• Distance of the planned trajectory to the chorda tympani is < 0.3mm
• Vulnerability
• Invalid or withdrawn informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

ARCI25

Experimental group

Description:

Robot assited Cochlear implant surgery.

Treatment:

Device: OTOPLAN

Device: HEARO