Status:
UNKNOWN
Auditory Diagnostics and Error-based Treatment
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Cochlear
Conditions:
Deafness, Bilateral
Deafness Neurosensory
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific erro...
Eligibility Criteria
Inclusion
- Adult (over 18 years old at the time of inclusion )
- Post-lingually deafened (the subject had a good mastery of spoken language before onset of deafness)
- Native Dutch speaker
- Implanted, either unilaterally or bilaterally, with a Cochlear Implant manufactured by Cochlear Ltd (i.e., a Nucleus ® implant).
- Implanted with one of the following implants: CI422, CI512, CI522, CI532, CI24M, CI24R, CI24RE.
- Implanted for at least 12 months.
Exclusion
- Known abnormally formed cochlea
- Known pre-implantation ossification of the cochlea
- Severe cognitive disorders affecting their ability to understand spoken language
- Intense facial nerve stimulation
- Unaddressed electrode tip foldover
- More than 4 electrodes deactivated because of malfunction (open/short circuit) or lack of response
- Additional illnesses or handicaps that could impact ability to participate in study, at the clinician's discretion.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05307952
Start Date
May 30 2022
End Date
December 1 2024
Last Update
July 5 2023
Active Locations (1)
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1
Radboud university medical center
Nijmegen, Gelderland, Netherlands, 6500