RecruitingNot ApplicableNCT05955469

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting

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.


Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Enrollment

20 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Adult patient (\>= 18 years old) speaking French
  • Patient who fulfils the criteria for cochlear implantation

Exclusion Criteria2

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

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Interventions

DEVICEFS4 then TFS4 (cochlear implant)

Cochlear implant with default fitting then with tonotopy-based fitting

DEVICETFS4 then FS4 (cochlear implant)

Cochlear implant with tonotopy-based fitting then with default fitting


Locations(1)

CHU Saint-Etienne

Saint-Etienne, France

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NCT05955469


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