Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
Key facts
- Who runs it
- Massachusetts Eye and Ear Infirmary
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 48 people, planned
- Started
- 27 Feb 2024
- Expected to end
- 26 Feb 2027
- Type of study
- Interventional, 4 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Changes in traditional follow-up
- Population mean mapping
- Record updated
- 20 May 2026
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients who select other cochlear implant manufactured devices
- Children under the age of 18
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Where in United States
- Mass Eye and EarBoston, United StatesContact: Julie ArenbergTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Population mean mapping, without 1 week follow-upTreatment being tested
Reduction in the number of follow-up visits and new programming strategy.
Treatment: Changes in traditional follow-up and Population mean mapping
- Population mean mapping, traditional follow-upTreatment being tested
New programming strategy
Treatment: Population mean mapping
- Traditional mapping*, without 1 week follow-upTreatment being tested
Reduction in the number of follow-up visits.
Treatment: Changes in traditional follow-up
- Traditional mapping, traditional follow-upNo study treatment, for comparison
Traditional follow-up plan
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06960616, who can take part
- Record updated
- 20 May 2026