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Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Study acronym: ABFmulti
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: Jan 2025 to Jan 2027v3 Show 5 more changesShow less
    • Primary endpoints: 2 to 4
    • Study sites: 1 to 2
    • Secondary endpoints: 17 to 31
    • Eligibility criteria expanded, about 2 words
    • Collaborators expanded, about 3 words
  2. Notable Primary and study completion dates: Oct 2023 to Jan 2025
    • Site contact updated
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.
Trial Details
NCT Number NCT05451628
Lead Sponsor Universitair Ziekenhuis Brussel
Collaborators: University Hospital, Antwerp
Conditions
(from sponsor)
Cochlear Implants, Sensorineural Hearing Loss
Related terms Hearing Loss, Sensorineural
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov