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

Not Applicable

Recruiting

• Conditions: Deafness; Cochlear Hearing Loss

• Registration Number: NCT06960616
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Study First Submitted: 2025-03-11
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-02-26
• Study Completion: 2026-02-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Speech perception scores	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	1-year	Time spent programming (seconds) at each visit

Secondary Outcome Measures

Name	Time	Method
Quality of Life questionnaire	1-year	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.
Soundfield detection thresholds	1-year	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.
programming levels	1-year	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.

Trial Locations

Locations (1)

Mass Eye and Ear; 🇺🇸 Boston, Massachusetts, United States