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Improving Cochlear Implant Outcomes Through Modeling and Programming Strategies Based on Human Inner Ear Pathology

NCT07683689 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-07-06

No results posted yet for this study

Summary

Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.

This study looks at whether customizing the way a cochlear implant is programmed, based on the health of the hearing nerve in different areas of the ear, can help people understand speech better in noisy settings. The researchers will adjust or turn off certain electrodes in areas where the nerve appears weaker, then test whether this improves hearing compared to each person's everyday program. They will also examine whether giving people time to get used to the new program leads to better results.

Conditions

  • Deafness

Interventions

DEVICE

Everyday Clinical Listening Program (Control)

The participant's standard clinical cochlear implant sound-processing program, as currently fit for everyday use. This serves as the within-subjects control condition and remains available as a backup throughout the take-home trial.

DEVICE

ENI-Based Experimental Program 1

An experimental cochlear implant sound-processing strategy that applies focused electrical fields for electrodes distant from regions of healthy neural tissue and/or deactivates channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model. Tested acutely in the lab and during one 4-week take-home interval.

DEVICE

ENI-Based Experimental Program 2

A second experimental cochlear implant sound-processing strategy applying focused electrical fields and/or channel deactivation based on electrode-neuron interface estimates, configured differently from Experimental Program 1. Tested acutely in the lab and during one 4-week take-home interval.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Julie Arenberg, PhD, CCC-A · Massachusetts Eye and Ear

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2028-07-30
Completion
2028-07-30

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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 NCT07683689 on ClinicalTrials.gov