Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Changes in traditional follow-up, Population mean mapping.
- Who it may be relevant to
- Registry conditions: Deafness, Cochlear Hearing Loss. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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. - Other 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.
Primary outcome measures
- Speech perception scores [Time frame: 1-year]
- Duration of programming session [Time frame: 1-year]
Secondary outcome measures (3)
- Quality of Life questionnaire [Time frame: 1-year]
- Soundfield detection thresholds [Time frame: 1-year]
- programming levels [Time frame: 1-year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mass Eye and Ear — Boston
Identifiers
NCT: NCT06960616 · 2024P000034