Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Jul 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to fit cochlear implants for people who have severe to profound hearing loss. A cochlear implant (CI) is a device that can help those who don't get enough benefit from regular hearing aids. The study aims to see if using a special fitting method based on a CT scan of the inner ear can help audiologists create a more personalized "map" for the cochlear implant. This could potentially improve how well the implant works for each individual, making sounds clearer and more natural.

To participate in this trial, you need to be at least 18 years old and have severe to profound hearing loss in one or both ears. You also need to have had a CT scan after getting the cochlear implant and must be using a specific type of implant from MED-EL. If you qualify, you’ll have the chance to try out this new fitting method, which may help you hear better. It's important to note that participants must be fluent in the language of the testing center and will need to give their consent before joining the study.

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)
• • Post-operative Computed Tomography (CT) scan of the CI electrode available
• • Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
• • Subject implanted with MED-EL cochlear implant(s)
• • Subjects received a Flex28, FlexSoft or Standard electrode
• • Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
• • Audio processor not yet activated on the newly implanted side
• • The most apical active electrode contact has to be inserted at least 450°
• • Minimum of 10 active channels can be activated
• • Fluent in the language of the test centre
• • Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
• Exclusion Criteria:
• • Lack of compliance with any inclusion criteria
• • Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
• • Implanted with C40+, C40X and C40C
• • Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
• • Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study