RecruitingNot ApplicableNCT06960616

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

Sponsor

Massachusetts Eye and Ear Infirmary

Enrollment

48 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

Deafness Cochlear Hearing Loss

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria6

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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Interventions

OTHERChanges 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.

OTHERPopulation 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.