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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Deafness
• Intervention / Treatment: Device: Everyday Clinical Listening Program (Control); Device: ENI-Based Experimental Program 1; Device: ENI-Based Experimental Program 2

Detailed Description

Cochlear implants are surgically placed in the inner ears of people with severe to profound hearing loss. Although these devices are generally successful, outcomes differ a great deal from one person to the next. Many people who use cochlear implants continue to struggle with understanding speech when there is background noise and with appreciating music. More research is needed to understand why results vary so much among cochlear implant users.

The main goal of this study is to better understand the underlying condition of the inner ear and how it relates to how well people hear with their cochlear implant. The researchers will use this knowledge to test new ways of programming the devices. A cochlear implant has multiple electrodes, and each one stimulates a different region of the hearing nerve. In some people, certain regions of the nerve are healthier than others. By estimating where the nerve is weaker or stronger, the researchers hope to program the device in a way that takes advantage of the healthier areas.

The study has one main aim with two parts:

The first part compares how well participants understand speech in noise using their usual everyday program versus an experimental program. In the experimental program, the electrical signal is narrowed and focused for electrodes that are farther from healthy nerve regions, and electrodes near poorly functioning nerve regions may be turned off. These adjustments are guided by a model of nerve health developed in earlier research.

The second part looks at whether performance improves after participants spend four weeks getting used to the experimental program. The researchers expect that programming based on each person's individual nerve health will improve their ability to understand speech in noise, and that this improvement will be greater after they have had time to adjust to the new program.

This work is expected to provide a better understanding of how long a person needs to adapt when their programming strategy changes. The findings could be applied fairly quickly in clinical settings to improve speech understanding for both adults and children who use cochlear implants.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Arenberg, PhD, CCC-A; Phone Number: 617-807-7904; Email: julie_arenberg@meei.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All Participants (Within-Subjects Crossover); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sentence Recognition in Noise After 4 Weeks of Acclimatization (Crossover)	Using a randomized crossover design, sentence recognition in noise (American Matrix Test) will be assessed before and after 4 weeks of at-home listening for the control program and each experimental program. The adaptive procedure yields a speech reception threshold in dB SNR, with lower (more negative) values indicating better performance. Participants complete 4 weeks of baseline testing with their clinical program followed by 4 weeks with each of the two experimental strategies. The outcome is the change in score across time points and programs, evaluating the effect of acclimatization.	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)	Using the randomized crossover design, medial vowel identification will be assessed before and after 4 weeks of at-home listening for the control and experimental programs. Performance is scored as percent correct, with higher values indicating better performance. The outcome evaluates the effect of acclimatization on performance.	Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Sound Quality Ratings	Participants rate the sound quality of the listening programs using a custom Sound Quality Questionnaire administered at baseline and at weekly intervals throughout the take-home trial. Results are reported as scores on the questionnaire's rating scale.	Baseline and weekly during the 12-week take-home trial
Electrically Evoked Compound Action Potential (ECAP)	The Electrically Evoked Compound Action Potential (ECAP) will be recorded via telemetry to measure the auditory nerve's response to electrical stimulation delivered through the cochlear implant. Response amplitude is reported in microvolts. This measure helps characterize the electrode-neuron interface used to inform the experimental programming strategies.	Collected during in-lab sessions (each up to 3.5 hours)
Electrical Field Imaging (EFI)	Electrical Field Imaging (EFI) will be recorded via telemetry to measure the distribution of electrical current within the cochlea where the implant electrodes are located. Recorded voltages are reported in volts. This measure helps characterize the electrode-neuron interface used to inform the experimental programming strategies.	Collected during in-lab sessions (each up to 3.5 hours)
Psychophysical Detection Threshold	Detection threshold, defined as the softest level at which the participant can detect a stimulus, will be measured across multiple electrode configurations including monopolar and novel focused stimulation modes. Thresholds are reported in clinical units (CU) as used for clinical device programming.	Collected during in-lab sessions (each up to 3.5 hours)
Maximum Comfortable Level (MCL)	Maximum comfortable level, defined as the level that is loud but still comfortable, will be measured across multiple electrode configurations including monopolar and novel focused stimulation modes. Levels are reported in clinical units (CU) as used for clinical device programming.	Collected during in-lab sessions (each up to 3.5 hours)

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Julie Arenberg, PhD, CCC-A, Massachusetts Eye and Ear

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cochlear implant
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Deafness
• Other Study ID Numbers: 2026P001659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No