Actively Recruiting
Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
Led by Massachusetts Eye and Ear Infirmary · Updated on 2026-05-20
48
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
M
Massachusetts Eye and Ear Infirmary
Lead Sponsor
C
Cochlear
Collaborating Sponsor
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postlingually deafened
- Adults aged 18 years and older
- New cochlear implant recipients using Cochlear Americas devices identified before activation
- Able to perform follow-up testing tasks such as repeating words, indicating hearing sounds, and completing questionnaires
- English speakers
You will not qualify if you...
- Using cochlear implant devices from manufacturers other than Cochlear Americas
- Pre-lingually deafened individuals
- Having multiple disabilities
- Unable to perform follow-up testing tasks such as repeating words, indicating hearing sounds, or completing questionnaires
- Non-English speakers
- Children under 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive cochlear implant programming using either a population mean mapping strategy or traditional mapping with varying follow-up schedules.
Follow-up visits at 1 month, 3 months, 6 months, and 1 year; 1-week follow-up may be omitted depending on assigned group
Trial Site Locations
Total: 1 location
1
Mass Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Arenberg
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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