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

Sponsor: Massachusetts Eye and Ear Infirmary • ClinicalTrials.gov ID: NCT07683689

Registry updated: 2026-10-09

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Description

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.

Interventions

Everyday Clinical Listening Program (Control) (Device)
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.
ENI-Based Experimental Program 1 (Device)
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.
ENI-Based Experimental Program 2 (Device)
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.

Eligibility criteria

Inclusion Criteria: * Age 18 - 80 years old * Native speakers of American English or Multilingual * Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer) * At least 6 months of listening experience with their cochlear implant, but could be recruited and consented prior. * Bilateral hearing loss Exclusion Criteria: * Inability to provide informed consent * Lost their hearing prior to the age of language acquisition (3-4 years) but did not receive a cochlear implant until adulthood * Do not have age-appropriate speech perception testing from clinical visits or do not use their implant for oral communication * Have neurological disease * Have unmanageable facial nerve stimulation or pain as a result of their implant * Does not tolerate implant well * Unable to carry out the study protocol or tasks required in the study * Poor vision such that the subject cannot adequately perform the study tasks on the computer screen

Conditions

Deafness

Locations

Massachusetts Eye and Ear — Boston, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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