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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Jan 1, 2026 to Jan 1, 2027v5
  2. Primary completion date: Sep 15, 2025 to Jan 1, 2026v4
  3. Start date: Oct 15, 2023 to Nov 5, 2024v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 15, 2023 to Oct 15, 2023
    • Site details revised
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 (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.
Trial Details
NCT Number NCT05955469
Lead Sponsor MED-EL Elektromedizinische Geräte GesmbH
Conditions
(from sponsor)		 Sensorineural Hearing Loss, Bilateral, Bilateral Hearing Loss
Related terms Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov