Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

November 25, 2025 updated by: Julie G. Arenberg, CCC-A, Massachusetts Eye and Ear Infirmary

Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners

Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Mass Eye and Ear
        • Contact:
        • Principal Investigator:
          • Julie Arenberg
      • Waltham, Massachusetts, United States, 02453

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria

  • Adult at least 18 years old
  • Native speakers of American English
  • Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

CHILDREN Inclusion Criteria

  • Children at least 3 months old
  • Native speakers of American English

  • Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

    • For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.

Exclusion Criteria:

Exclusion for all Cochlear Implant Subjects:

  • Inability to provide informed consent
  • Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device
  • Unable to carry out the study protocol or tasks required in the study

Exclusion for all Normal Hearing Subjects:

  • Inability to provide informed consent
  • Hearing loss, or significant history of hearing related issues
  • Unable to carry out the study protocol or tasks required in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Performance Assessed with Experimental Sound Processing Strategy
Patients listening to experimental cochlear implant processing strategy.
Other: Experimental Speech Processing Strategy
Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.
No Intervention: Control
Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).
Sham Comparator: Experimental Control
Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.
Other: Experimental Speech Processing Strategy
Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Slopes of the spread of excitation of the electrically evoked compound action potential responses
Time Frame: Baseline
Responses of the auditory nerve can be measured directly from the cochlear implant using software developed by the implant manufacturer. By changing the distance between two electrodes, we can quantify the spread of activation in the cochlea.
Baseline
Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.
Time Frame: Baseline
A behavioral test designed to measure how spectral information is processed in the auditory system. By changing the relationship between a masker and target signal, we can assess resolution.
Baseline
Changes in vowel identification scores
Time Frame: Baseline and weekly for 10 weeks after the intervention
Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.
Baseline and weekly for 10 weeks after the intervention
Changes in sentence recognition scores
Time Frame: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.
Baseline and weekly for 10 weeks after the intervention
Changes in speech-gap detection thresholds
Time Frame: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.
Baseline and weekly for 10 weeks after the intervention
Changes in phoneme discrimination scores
Time Frame: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.
Baseline and weekly for 10 weeks after the intervention
Changes in time (weeks) with programming strategy
Time Frame: Baseline and weekly for 10 weeks after the intervention
Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed.
Baseline and weekly for 10 weeks after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Age at baseline
A secondary age analysis on all outcome measures will be applied.
Age at baseline
Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores
Time Frame: Baseline, and weekly for 10 weeks after the intervention
The IT-MAIS is a study-team-guided parental report about how infants and toddlers are responding to sound.
Baseline, and weekly for 10 weeks after the intervention
Macarthur-Bates vocabulary inventory scores
Time Frame: Baseline, and weekly for 10 weeks after the intervention
This test allows the study team and parents to monitor speech and language development, specifically new word learning.
Baseline, and weekly for 10 weeks after the intervention
Hearing quality of life (HEARQL) scores
Time Frame: Baseline, 5 weeks, and 10 weeks after the intervention
The HEAR-QL is a self-assessment test normed for children to assess how they hear in everyday life with different interventions
Baseline, 5 weeks, and 10 weeks after the intervention
Sound quality questionnaire
Time Frame: Baseline and weekly for 10 weeks after the intervention
Participants will be asked to rate sound quality with different interventions in comparison to their everyday listening on a 7-point scale (from minus 3 - much worse, up to plus 3 - much better, 0 is the same)
Baseline and weekly for 10 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts Eye and Ear Infirmary

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Children's Hospital
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julie Arenberg, Massachusetts Eye and Ear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MGB_2019P000239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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