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NCT Number: NCT06960616

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass Eye and Ear

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Julie Arenberg

CONTACT

[email protected]

617-807-7904

Julie Arenberg

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

  2. Duration of programming session

    Time frame: 1-year

    Time spent programming (seconds) at each visit

Secondary outcomes

  1. Quality of Life questionnaire

    Time frame: 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.

  2. Soundfield detection thresholds

    Time frame: 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.

  3. programming levels

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arenberg

CONTACT

[email protected]

6178077904

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Collaborators

  • Cochlear

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 7, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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