NCT06960616 Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
| NCT ID | NCT06960616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Deafness |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-02-27 |
| Primary Completion | 2026-11-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-02-27 with a primary completion date of 2026-11-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Julie Arenberg
PRINCIPAL INVESTIGATOR
Massachusetts Eye and Ear
Frequently Asked Questions
Who can join the NCT06960616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Deafness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960616 currently recruiting?
Yes, NCT06960616 is actively recruiting participants. Contact the research team at julie_arenberg@meei.harvard.edu for enrollment information.
Where is the NCT06960616 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06960616 clinical trial?
NCT06960616 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Julie Arenberg at Massachusetts Eye and Ear. The trial plans to enroll 48 participants.