An interventional study of Changes in traditional follow-up and Population mean mapping in Deafness and Cochlear Hearing Loss, sponsored by Massachusetts Eye and Ear Infirmary. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Treatment
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.
160 studies on the registry are indexed under Deafness; 46 are open to participants now.
This study's planned enrollment of 48 is above the median of 43 across 106 interventional studies indexed under Deafness.
Browse Deafness studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Reduction in the number of follow-up visits and new programming strategy.
Other: Changes in traditional follow-up · Other: Population mean mapping
New programming strategy
Other: Population mean mapping
Reduction in the number of follow-up visits.
Other: Changes in traditional follow-up
Traditional follow-up plan
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.
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.
Speech perception scores
Speech perception scores via CNC word lists (percentages) at each visit. Scores are from 0 to 100% with 100% being the best.
Time frame: 1-year
Duration of programming session
Time spent programming (seconds) at each visit
Time frame: 1-year
Quality of Life questionnaire
Patient outcomes via the Cochlear Implant Quality of Life-35 Profile questionnaire at each visit. Scores are out of 35 points and higher scores indicate better quality of life.
Time frame: 1-year
Soundfield detection thresholds
Change in soundfield detection thresholds (dB HL) between each visit. Detection thresholds should be between 20 and 35 dB HL and anywhere in that range is good.
Time frame: 1-year
programming levels
Change in programming levels between each visit (converted measure from CL to charge units). There is no indication of good and bad with programming levels, we are just measuring what they are and how stable they are over time.
Time frame: 1-year
Started Feb 2024 (actual). Primary completion is estimated for Nov 2026, 32 months after the start.
Of 50 non-industry interventional studies with no phase under Deafness, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20. This study's planned 32 months is below that.
Counting every sponsor, half of 58 studies reached it within 31 months; a quarter within 17.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts Eye and Ear Infirmary →