NCT06960616

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deafness
• Cochlear Hearing Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-27
• Primary completion: 2026-02-26
• Completion: 2026-02-26
• First posted: 2025-05-07
• Last updated: 2025-05-09

Locations

1 site across 1 country: United States