Status:
UNKNOWN
Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Cochlear Implants
Sensorineural Hearing Loss, Bilateral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05369598
Start Date
March 1 2022
End Date
February 1 2025
Last Update
December 12 2023
Active Locations (1)
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1
UZ Brussel
Brussels, Belgium, 1090