DeafnessNCT06960616
Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
A study testing Changes in traditional follow-up and Population mean mapping in people with Deafness and Cochlear Hearing Loss, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Deafness, Cochlear Hearing Loss
- What is being tested?
- Changes in traditional follow-up and Population mean mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2024to 26 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Patients who select other cochlear implant manufactured devices
- 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
- Children under the age of 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass Eye and Ear
Boston, Massachusetts, 02114
Julie Arenberg, 617-807-7904, julie_arenberg@meei.harvard.edu
Julie Arenberg
About this study
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
- Being tested
- Changes in traditional follow-up, Population mean mapping
- Medical subject headings
- Deafness, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in traditional follow-upOther
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.
Population mean mappingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Population mean mapping, without 1 week follow-up | Experimental | Reduction in the number of follow-up visits and new programming strategy. Receives: Other: Changes in traditional follow-up; Other: Population mean mapping |
| Population mean mapping, traditional follow-up | Experimental | New programming strategy Receives: Other: Population mean mapping |
| Traditional mapping*, without 1 week follow-up | Experimental | Reduction in the number of follow-up visits. Receives: Other: Changes in traditional follow-up |
| Traditional mapping, traditional follow-up | No intervention | Traditional follow-up plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-year
Duration of programming session
Time spent programming (seconds) at each visit
Measured: 1-year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start27 Feb 2024
- Primary completion26 Nov 2026 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear
- Responsible party
- Principal investigator, Julie G. Arenberg, CCC-A, Massachusetts Eye and Ear Infirmary
- Investigators
- Julie Arenberg, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960616
- Sponsor's protocol ID
- 2024P000034
- Status last verified
- May 2026
- First submitted
- 11 Mar 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
- ClinicalTrials.gov ID
- NCT06960616
- Acronym / sponsor ID
- 2024P000034
- Conditions
- Deafness, Cochlear Hearing Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- Cochlear
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Population mean mapping, without 1 week follow-up | Experimental | Other: Changes in traditional follow-up, Other: Population mean mappingReduction in the number of follow-up visits and new programming strategy. |
| Population mean mapping, traditional follow-up | Experimental | Other: Population mean mappingNew programming strategy |
| Traditional mapping*, without 1 week follow-up | Experimental | Other: Changes in traditional follow-upReduction in the number of follow-up visits. |
| Traditional mapping, traditional follow-up | No intervention | –Traditional follow-up plan |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Patients who select other cochlear implant manufactured devices
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changes in traditional follow-upTraditional 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, without 1 week follow-up, Traditional mapping*, without 1 week follow-up |
| Population mean mappingTraditional 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. | Other | Population mean mapping, traditional follow-up, Population mean mapping, without 1 week follow-up |
Primary outcome
Speech perception scores
Time frame: 1-year
Speech perception scores via CNC word lists (percentages) at each visit. Scores are from 0 to 100% with 100% being the best.
Duration of programming session
Time frame: 1-year
Time spent programming (seconds) at each visit
3 secondary outcomes
Quality of Life questionnaire
Time frame: 1-year
Soundfield detection thresholds
Time frame: 1-year
programming levels
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Arenberg principal investigator
Massachusetts Eye and Ear
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changes in traditional follow-up and Population mean mapping in people with Deafness and Cochlear Hearing Loss, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arenberg (6178077904, julie_arenberg@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech perception scores (time frame: 1-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.