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Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy

NCT06960616 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Cochlear

    collaborator INDUSTRY

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Julie Arenberg · Massachusetts Eye and Ear

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2026-11-26
Completion
2027-02-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960616 on ClinicalTrials.gov