Recruiting

Cochlear Mapping

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT06960616

Conditions

Deafness

Cochlear Hearing Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Changes in traditional follow-up

Population mean mapping

Study Details

Brief 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. 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

Study ID

NCT06960616

Start date

Feb 27, 2024

Status verified date

May, 2026

Completion date

Feb 26, 2027

Anticipated

Primary completion date

Nov 26, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Population mean mapping, without 1 week follow-up

Reduction in the number of follow-up visits and new programming strategy.

experimental: Population mean mapping, traditional follow-up

New programming strategy

experimental: Traditional mapping*, without 1 week follow-up

Reduction in the number of follow-up visits.

no intervention: Traditional mapping, traditional follow-up

Traditional follow-up plan

Interventions

Changes in traditional follow-up

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 mapping

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.

Primary outcome measure

  • Speech perception scores [ Time Frame: 1-year ]
  • Duration of programming session [ Time Frame: 1-year ]

Central Contacts and Locations

Central contacts

Arenberg

6178077904julie_arenberg@meei.harvard.edu

Locations

Mass Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Julie Arenberg

617-807-7904julie_arenberg@meei.harvard.edu

Principal Investigator:

Julie Arenberg

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-05-20.