New software to help guide electrode insertion during cochlear implant surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests the OTOGUIDE software during cochlear implant procedures. It aims to provide real-time feedback on electrode position, insertion depth, and function to assist surgeons. Eligible participants are adults receiving a compatible MED-EL cochlear implant at selected centers. The study focuses on whether the software can improve precision and potentially hearing outcomes without altering standard surgical steps. Results will inform whether this technology can be integrated into routine cochlear implant procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Minimum age of eighteen (18) years at time of enrolment.
* Subjects to be implanted with a compatible MED-EL cochlear implant (CI) (Mi1200 SYNCHRONY (PIN), Mi1210 SYNCHRONY ST, Mi1250 SYNCHRONY 2 (PIN), Mi1260 SONATA 2) according to clinical routine.
* Signed and dated informed consent before the start of any study-specific procedure.

Exclusion Criteria:

* Previously having received a CI on the ear to be tested (Re-implantation).
* Evidence of ossification or any other cochlear anomaly (e.g., malformation) that might prevent complete insertion of the electrode array or might cause increased risk of infection (e.g. dysplastic cochlear), as confirmed by medical examination and/or as per CT/MRI.
* Known absence of cochlear development or if the cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway.
* Evidence of active external or middle ear infection or history of recurrent middle ear infection in the ear to be implanted.
* Acute cholesteatoma
* The tympanic membrane is perforated in the ear to be implanted.
* Pre-existing condition known to prohibit CT imaging before and after cochlear implantation.
* Women being pregnant or nursing.
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.

Where it's running

• Medizinische Universität Innsbruck
  Innsbruck, Tyrol, Austria Recruiting
• Klinikum der Universität München, Campus Großhadern Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde
  Munich, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Jasmine Rinnofner
• Email: jasmine.rinnofner@medel.com
• Phone: +43577881694

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes of MED-EL SONATA 2 Cochlear Implants in real life

  This study looks at long-term results from people who received a SONATA 2 cochlear implant to see how well it works in everyday life.

  Recruiting MED-EL Elektromedizinische Geräte GmbH · Madrid and 1 other locations · NCT07697911

• Long-term hearing and speech outcomes after cochlear implants

  This project will see if cochlear implants improve hearing, speech understanding, and quality of life in Mandarin-speaking patients of all ages before and after surgery.

  Recruiting Eye & ENT Hospital of Fudan University · Shanghai · NCT07380269

• Perceptual adaptation after cochlear implantation

  This trial will try different frequency maps in adults who just received a cochlear implant in one ear to see which map improves sound quality, device use, and speech understanding.

  Recruiting NYU Langone Health · New York, New York · NCT07039435

• Robotic versus manual cochlear implant electrode insertion to reduce inner-ear trauma.

  This test tries a robotic insertion tool versus the usual manual technique to see if it reduces inner-ear damage and preserves residual hearing in people getting cochlear implants.

  Recruiting University of Iowa · Iowa City, Iowa · NCT06951594

• Using robotics and electrocochleography for cochlear implant surgery

  This study is testing if using a robotic system during cochlear implant surgery can help improve outcomes for people with hearing loss.

  Recruiting iotaMotion, Inc. · Iowa City, Iowa · NCT06664710

• Using mild cooling during cochlear implant surgery to preserve hearing

  This study tests if using mild cooling during cochlear implant surgery can help people with severe hearing loss keep some of their natural hearing.

  Recruiting Restorear Devices LLC · Miami, Florida · NCT06375278

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.