Evaluating a new fitting method for cochlear implants using robotic 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 study investigates a novel fitting strategy for cochlear implants (CIs) that utilizes post-operative CT scans to create a personalized frequency-band distribution. The aim is to improve sound perception for patients with severe to profound sensorineural hearing loss who have undergone Robot Assisted Cochlear Implant Surgery (RACIS). Participants will be fitted with either a standard clinical approach or the new anatomy-based fitting (ABF) method, allowing for a comparison of audiological and quality of life outcomes. The study focuses on patients implanted with specific MED-EL cochlear implants and audio processors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
* Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
* Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage
* Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side
* Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid)
* Pre- operative and post-operative CT scan of the temporal bone available
* Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
* Audio processor not yet activated on the newly implanted side
* Minimum of 10 active channels can be activated
* Fluent in the language of the test centre (Dutch or French)
* Signed and dated ICF before the start of any study-specific procedure

Exclusion Criteria:

* Subject is a Single-Sided Deafness (SSD) CI user
* Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
* Lack of compliance with any inclusion criteria
* 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

• UZ Brussel
  Brussel, Belgium Recruiting

Study contacts

• Principal investigator: Vedat Topsakal, Prof. — Uzb-Vub
• Study coordinator: Emilie Heuninck
• Email: emilie.heuninck@uzbrussel.be
• Phone: 024749772

Similar studies

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

• Comparing speech understanding methods for cochlear implant users

  This study tests whether a new way of setting up cochlear implants helps adults understand speech better in noisy places compared to the traditional method.

  Recruiting MED-EL Elektromedizinische Geräte GmbH · Dijon · NCT06737185

• Comparing speech perception with different cochlear implant settings

  This study tests whether different settings on cochlear implants can help adults hear and understand speech better in noisy situations.

  Recruiting MED-EL Elektromedizinische Geräte GmbH · Limoges · NCT06723262

• Comparing computer-based auditory training with standard care for cochlear implant patients

  This study tests if a free computer-based training program can help adults with cochlear implants understand speech better and improve their quality of life compared to standard training methods.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT06607146

• Comparing two surgical methods for cochlear implants

  This study is testing which of two surgical methods for cochlear implants helps adults with severe hearing loss keep their natural hearing and improves their overall sound experience.

  Recruiting Radboud University Medical Center · Nijmegen · NCT06453343

• 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

• Measuring electrical stapedial reflex thresholds for cochlear implant programming

  This study is testing if measuring electrical responses in the ear can help improve cochlear implant settings for children with severe hearing loss to make their listening experience better.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT06051006

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.