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Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
Sponsor: MED-EL Elektromedizinische Geräte GesmbH
Summary
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise. Secondary objectives: Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.
Official title: Comparison of Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-11-05
Completion Date
2027-01-01
Last Updated
2026-01-20
Healthy Volunteers
No
Interventions
FS4 then TFS4 (cochlear implant)
Cochlear implant with default fitting then with tonotopy-based fitting
TFS4 then FS4 (cochlear implant)
Cochlear implant with tonotopy-based fitting then with default fitting
Locations (1)
CHU Saint-Etienne
Saint-Etienne, France