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

NCT06960616 | Recruiting

• 1 other identifier: 2024P000034
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  1-year

• Duration of programming session

  Time spent programming (seconds) at each visit

  1-year

Secondary Outcomes (3)

• Quality of Life questionnaire

  1-year

• Soundfield detection thresholds

  1-year

• programming levels

  1-year

Study Arms (4)

Population mean mapping, without 1 week follow-up

EXPERIMENTAL

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

Other: Changes in traditional follow-up; Other: Population mean mapping

Population mean mapping, traditional follow-up

EXPERIMENTAL

New programming strategy

Other: Population mean mapping

Traditional mapping*, without 1 week follow-up

EXPERIMENTAL

Reduction in the number of follow-up visits.

Other: Changes in traditional follow-up

Traditional mapping, traditional follow-up

NO INTERVENTION

Traditional follow-up plan

Interventions

Changes in traditional follow-up OTHER

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, without 1 week follow-up; Traditional mapping*, without 1 week follow-up

Population mean mapping OTHER

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.

Population mean mapping, traditional follow-up; Population mean mapping, without 1 week follow-up

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Cochlear: collaborator

Study Sites (1)

Mass Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Deafness; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Arenberg

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arenberg

CONTACT

6178077904; julie_arenberg@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: May 7, 2025
• Study Start: February 27, 2024
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

US (1)