Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · May 5, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a new way of programming cochlear implants (CIs) can improve hearing outcomes and quality of life for people with severe to profound hearing loss. Right now, many CIs are set using a standard approach that doesn’t consider the individual shapes and sizes of patients' inner ears. This study will use special imaging from CT scans to create a more personalized fitting plan that aims to match natural hearing patterns better. Participants will be patients who have already received a cochlear implant through a robotic surgery system and are using specific types of MED-EL implants.

To be eligible for this trial, participants must be at least 18 years old and have severe to profound hearing loss in one or both ears. They need to be implanted with a MED-EL cochlear implant and are set to receive a specific audio processor. Additionally, they should have had pre-operative hearing tests and scans available. Participants will undergo assessments to see how well this new fitting strategy works for them, and they can expect to be part of a study that may lead to better hearing solutions for others in the future.

Gender

ALL

Eligibility criteria

• 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