RecruitingNot ApplicableNCT05898659

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization

Comparison of a Bimodal Fitting With Synchronization and a Conventional Bimodal Fitting in Newly Implanted Cochlear Patient. Prospective Monocentric Randomized Double-blind Crossover Study.

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Enrollment

20 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Sensorineural Hearing Loss, Bilateral

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

Min Age: 18 Years

Inclusion Criteria3

Adult patient (\>= 18 years old) speaking French
Patient who fulfils the criteria for cochlear implantation
Total hearing loss for less than 5 years

Exclusion Criteria2

retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
patient with residual hearing \< 70 dB hearing level (HL) at 250 Hz and 500 Hz and \< 80 dB HL at 1000 Hz on the contralateral ear

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Interventions

DEVICEABFnoS then ABFS (Cochlear implant)

Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid

DEVICEABFS then ABFnoS (Cochlear implant)

Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid