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Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy

RecruitingNAAges 18 Years - 85 YearsAllMassachusetts Eye and Ear Infirmary
NCT06960616 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study is about the importance of each follow-up visit after activating a new cochlear implant in addition to evaluating the effectiveness and efficiency of a new programming strategy from Cochlear Americas. Investigators are looking for patients who have recently selected Cochlear Americas as their cochlear implant manufacturer of choice for their upcoming surgery. The aim of this study is to determine if 1) patient outcomes remain stable when reducing follow-up appointments and 2) Cochlear's population mean mapping can produce similar outcomes with patients while additionally reducing appointment times. The hypothesis is that using population mean mapping and reducing the number of follow-up visits after activation will yield similar performance outcomes to a standard of care while decreasing the length of appointment times and number of appointments needed for each patient.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Postlingually deafened * Adults (18+) * New cochlear implant recipients with Cochlear Americas devices; identified prior to activation * Able to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires) * English speakers Exclusion Criteria: * Patients who select other cochlear implant manufactured devices * Pre-lingually deafened * Multiple disabilities * Unable to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires) * Non-English speakers * Children under the age of 18
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What it tests

  • Changes in traditional follow-up
  • Population mean mapping
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Where

1 site
Mass Eye and Ear
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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