Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
NCT ID: NCT06960616
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2024-02-27
2026-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Population mean mapping, without 1 week follow-up
Reduction in the number of follow-up visits and new programming strategy.
Changes in traditional follow-up
Traditional follow-up includes the following visits after activation: 1-week, 1-month, 3-months, 6-months and 1 year. With the intervention used, the 1-week follow-up is removed.
Population mean mapping
Traditional mapping at activation involves the measurement of at least 5 electrodes (both T-levels and C-levels). The intervention uses a population mean mapping strategy where there is a pre-set dynamic range of 46 CL with a spot check of C-levels.
Population mean mapping, traditional follow-up
New programming strategy
Population mean mapping
Traditional mapping at activation involves the measurement of at least 5 electrodes (both T-levels and C-levels). The intervention uses a population mean mapping strategy where there is a pre-set dynamic range of 46 CL with a spot check of C-levels.
Traditional mapping*, without 1 week follow-up
Reduction in the number of follow-up visits.
Changes in traditional follow-up
Traditional follow-up includes the following visits after activation: 1-week, 1-month, 3-months, 6-months and 1 year. With the intervention used, the 1-week follow-up is removed.
Traditional mapping, traditional follow-up
Traditional follow-up plan
No interventions assigned to this group
Interventions
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Changes in traditional follow-up
Traditional follow-up includes the following visits after activation: 1-week, 1-month, 3-months, 6-months and 1 year. With the intervention used, the 1-week follow-up is removed.
Population mean mapping
Traditional mapping at activation involves the measurement of at least 5 electrodes (both T-levels and C-levels). The intervention uses a population mean mapping strategy where there is a pre-set dynamic range of 46 CL with a spot check of C-levels.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Massachusetts Eye and Ear Infirmary
OTHER
Responsible Party
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Julie G. Arenberg, CCC-A
Principal Investigator
Principal Investigators
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Julie Arenberg
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear
Locations
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Mass Eye and Ear
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024P000034
Identifier Type: -
Identifier Source: org_study_id
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