Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization. Secondary objectives: Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patient (\>= 18 years old) speaking French
• Patient who fulfils the criteria for cochlear implantation
• Total hearing loss for less than 5 years
Locations
Other Locations
France
CHU Nice
RECRUITING
Nice
Contact Information
Primary
Vincent Péan, PhD
vincent.pean@medel.com
0603592974
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 20
Treatments
Active_comparator: ABFnoS then ABFS
Cochlear Implant with ABFnoS first during 6 weeks then with ABFS during 6 weeks
Active_comparator: ABFS then ABFnoS
Cochlear Implant with ABFS first during 6 weeks then with ABFnoS during 6 weeks
Related Therapeutic Areas
Sponsors
Leads: MED-EL Elektromedizinische Geräte GesmbH