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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 15, 2025 to Dec 15, 2026v7
  2. Primary completion date: Jun 15, 2025 to Dec 15, 2025v6
  3. Primary completion date: Dec 15, 2024 to Jun 15, 2025
    • Study completion date: Jun 15, 2025 to Dec 15, 2025
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 15, 2023 to Oct 17, 2023
    • Site details revised
    v3
  6. Start date: Jun 15, 2023 to Sep 15, 2023v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05898659
Lead Sponsor MED-EL Elektromedizinische Geräte GesmbH
Conditions
(from sponsor)		 Sensorineural Hearing Loss, Bilateral
Related terms Hearing Loss, Sensorineural
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov