Actively Recruiting
Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patients Prospective Monocentric Randomized Double-blind Crossover Study
Led by MED-EL Elektromedizinische Geräte GesmbH · Updated on 2026-01-14
20
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying adults with bilateral sensorineural hearing loss who have recently received cochlear implants. The trial compares two fitting strategies for bimodal hearing, which combines a cochlear implant (CI) in one ear and a hearing aid (HA) in the other. The study aims to evaluate whether synchronizing the sound processing between the CI and HA improves the accuracy of sound localization, speech perception in noise, and auditory skills. Participants will experience two different fitting strategies in a randomized crossover design. One strategy (ABFS) synchronizes the processing times of the cochlear implant and the hearing aid, while the other (ABFnoS) does not synchronize them. Each participant will use one strategy for 6 weeks and then switch to the other for another 6 weeks. This allows direct comparison of the two approaches within the same individuals. During the study, participants will be assessed at 6 weeks and 12 weeks after activation of their cochlear implant. Researchers will measure how accurately participants can localize sounds, the bias in sound localization, their speech recognition in noisy environments, and the auditory experiences reported by the participants. This trial is conducted with careful monitoring to evaluate these outcomes over the 12-week period following implant activation.
CONDITIONS
Brief Title
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (18 years or older) who speaks French
- Meets criteria for cochlear implantation
- Has had total hearing loss for less than 5 years
You will not qualify if you...
- Retro-cochlear pathology such as auditory neuropathy or vestibular schwannoma
- Residual hearing less than 70 dB hearing level at 250 Hz and 500 Hz and less than 80 dB HL at 1000 Hz on the opposite ear to the cochlear implant side
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 12 weeks total (two 6-week periods)
Participants receive two different cochlear implant fitting strategies in a randomized order, each for 6 weeks. One strategy synchronizes the cochlear implant with the contralateral hearing aid, and the other does not.
Visits at 6 weeks and 12 weeks post-activation
Trial Site Locations
Total: 1 location
1
CHU Nice
Nice, France, 06103
Actively Recruiting
Research Team
V
Vincent Péan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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