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

Last updated: May 6, 2025
Sponsor: Massachusetts Eye and Ear Infirmary
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Deafness

Auditory Loss And Deafness

Treatment

Changes in traditional follow-up

Population mean mapping

Clinical Study ID

NCT06960616
2024P000034
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postlingually deafened

  • Adults (18+)

  • New cochlear implant recipients with Cochlear Americas devices; identified prior toactivation

  • Able to perform follow-up testing tasks (repeating words/sentences, indicating theyheard a sound stimulus, completing questionnaires)

  • English speakers

Exclusion

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, indicatingthey heard a sound stimulus, completing questionnaires)

  • Non-English speakers

  • Children under the age of 18

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Changes in traditional follow-up
Phase:
Study Start date:
February 27, 2024
Estimated Completion Date:
February 26, 2026

Connect with a study center

  • Mass Eye and Ear

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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