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

NCT07683689 | Not Yet Recruiting

• 1 other identifier: 2026P001659
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

cochlear implant

Outcome Measures

Primary Outcomes (2)

• Change in Sentence Recognition in Noise (Everyday Program vs. Experimental Programs), In-Lab

  Sentence recognition in background noise will be measured using the American Matrix Test (AMT), an adaptive, closed-set speech-in-noise test consisting of 4 blocks of 20 sentences each (5 words per sentence). The adaptive procedure yields a speech reception threshold expressed in dB SNR, the signal-to-noise ratio at which the participant correctly identifies 50 percent of words, with lower (more negative) values indicating better performance. Scores obtained with the participant's everyday clinical listening program (control) will be compared to scores obtained with two experimental sound-processing strategies that apply focused electrical fields for distant electrodes and/or deactivate channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model.

  Across a minimum of two in-lab sessions (each up to 3.5 hours)

• Change in Vowel Identification (Everyday Program vs. Experimental Programs), In-Lab

  Medial vowel identification will be measured using a closed-set vowel discrimination task in quiet and at a +10 dB signal-to-noise ratio in four-talker babble noise. Performance is scored as percent correct, with higher values indicating better performance. Scores obtained with the participant's everyday clinical program (control) will be compared to scores obtained with the two experimental sound-processing strategies.

  Across a minimum of two in-lab sessions (each up to 3.5 hours)

Secondary Outcomes (2)

• Change in Sentence Recognition in Noise After 4 Weeks of Acclimatization (Crossover)

  Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial

• Change in Vowel Identification After 4 Weeks of Acclimatization (Crossover)

  Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial

Other Outcomes (5)

• Subjective Sound Quality Ratings

  Baseline and weekly during the 12-week take-home trial

• Electrically Evoked Compound Action Potential (ECAP)

  Collected during in-lab sessions (each up to 3.5 hours)

• Electrical Field Imaging (EFI)

  Collected during in-lab sessions (each up to 3.5 hours)

Study Arms (1)

All Participants (Within-Subjects Crossover)

EXPERIMENTAL

This is a within-subjects study in which all enrolled participants receive every condition. Each participant's everyday clinical listening program serves as the control and is compared against two experimental sound-processing strategies based on electrode-neuron interface (ENI) estimates. In the in-lab phase (Sub-Aim 1.1), all programs are compared acutely. In the take-home phase (Sub-Aim 1.2), participants complete a 12-week crossover consisting of 4 weeks with their clinical program followed by 4 weeks with each experimental strategy, with the order of programs randomized.

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

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.

All Participants (Within-Subjects Crossover)

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.

All Participants (Within-Subjects Crossover)

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.

All Participants (Within-Subjects Crossover)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

MeSH Terms

Conditions

Deafness

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, PhD, CCC-A

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Arenberg, PhD, CCC-A

CONTACT

617-807-7904; julie_arenberg@meei.harvard.edu

Study Design

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

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share