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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06960616

Evaluating Reduced Follow-up Visits and Population Mean Mapping for Adults with Cochlear Americas Implants

Led by Massachusetts Eye and Ear Infirmary · Updated on 2026-05-20

48

Participants Needed

1

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of reducing the number of follow-up visits after activating a new cochlear implant, along with assessing a new programming strategy from Cochlear Americas. The study aims to see if patient outcomes remain stable with fewer visits and whether the population mean mapping strategy can deliver similar results while shortening appointment times. This research focuses on adults who have newly chosen Cochlear Americas for their cochlear implant surgery. Participants will be randomly assigned to one of four groups using population mean mapping with or without the 1-week follow-up visit, or traditional mapping with or without the 1-week follow-up. Traditional follow-up includes visits at 1 week, 1 month, 3 months, 6 months, and 1 year after activation, while some groups omit the 1-week visit. The population mean mapping strategy uses a preset dynamic range with a spot check of programming levels, differing from traditional mapping, which involves detailed electrode measurements. During the study, participants will undergo speech perception testing, programming sessions, and complete quality of life questionnaires at 1 year. Researchers will measure speech perception scores and the length of programming sessions as primary outcomes, along with secondary measures like soundfield detection thresholds and programming levels. The study will monitor how well patients adapt and perform with different follow-up schedules over a one-year period, aiming to improve clinical efficiency without compromising patient outcomes.

CONDITIONS

Brief Title

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

Research Team

A

Arenberg

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