Novel Coding Strategies for Children With Cochlear Implants

March 2, 2026 updated by: NYU Langone Health
The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory system. Information from individuals with and without cochlear implants will be compared.

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.

Detailed Description

The overall objectives of this research are to 1) gain a better understanding of fundamental psychophysical abilities with electrical stimulation as a function of age (child vs adult), age at onset of deafness (pre- vs post-lingual), and acoustic hearing (normal vs limited or residual); and 2) determine whether manipulations in CI coding strategies will improve psychophysical and speech recognition outcomes for early implanted children. This work is expected to provide new insights into the corresponding improvements in perceptual outcomes to these newer strategies have been modest at best and performance has begun to level off.

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.
190

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 Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • David M Landsberger, MD

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

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be 7 years of age or older and pre-lingually implanted with a cochlear implant (before the age of 2 years), have aided residual hearing, or have normal hearing.
  • Be ages 18 or older and post-lingually implanted or have normal hearing.
  • Be ages 18-35 and pre-lingually implanted.

Exclusion Criteria:

  • Any child implanted post-lingually

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel 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: Late Adult Cochlear Implant (LateAdultCI)
Post-lingually implanted adults, 18+ years
Other: Single-Electrode Pulse Train
AIM 2 - Stimuli will be presented on one of three electrodes (apical, middle, and basal) at an amplitude between 10 and 100% dynamic range in µAs in 10% dynamic range steps. Stimulation will be delivered at a rate of 1000 pps. The process will be repeated in random order until 20 loudness estimates are obtained for each stimulus (3 electrodes x 2 rates x 10 amplitudes) for each subject. The dynamic range will be determined by measuring the maximum acceptable loudness (MAL) and threshold for each of the stimuli. MAL will be measured by slowly raising the current level for each stimulus until the subject reports that it is as loud as they are willing to accept without becoming uncomfortably loud.
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks
AIM 1 - MDT will be set at 150 Hz. Testing will be conducted in soundfield in a sound booth at 60 dB Sound Pressure Level (SPL) while the participant listens with both implants adjusted to user setting.
Other: Sound coding strategy.
Aim3 - Spectral-temporally modulated ripple test (SMRT), Quick Spectral Modulation Detection (QSMD), Modulation Detection, Gap Detection. CNC words will be set in quiet and Az-Bio/BabyBio sentences in quiet and multi-talker babble (+10 and +5 dB SNR) using both the subject's clinical map and the new reduced channels map. Tests will be presented in the soundfield at 60 dB SPL
Experimental: Early Child Cochlear Implant (EarlyChildCI)
Early implanted children, ages 7-17 years
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks
AIM 1 - MDT will be set at 150 Hz. Testing will be conducted in soundfield in a sound booth at 60 dB Sound Pressure Level (SPL) while the participant listens with both implants adjusted to user setting.
Other: Sound coding strategy.
Aim3 - Spectral-temporally modulated ripple test (SMRT), Quick Spectral Modulation Detection (QSMD), Modulation Detection, Gap Detection. CNC words will be set in quiet and Az-Bio/BabyBio sentences in quiet and multi-talker babble (+10 and +5 dB SNR) using both the subject's clinical map and the new reduced channels map. Tests will be presented in the soundfield at 60 dB SPL
Other: Electric-only spectral resolution
Aim 1- Spectral resolution will be tested using frequency allocations consisting of the full default clinical range as well as the subject's clinical frequency allocation if they differ. For Hybrid electrode users in which electrode contacts are closer in proximity in the cochlea, maps with a frequency allocation of 938-7938 Hz will also be tested in that it will closely approximate the frequency spacing of a Nucleus Contour Advance electrode array. Spectral resolution will be measured with three repetitions of the SMRT and one repetition of the QSMD test. Testing will be presented at 60 dB SPL in the soundfield with the acoustic ear plugged and muffed.
Experimental: Early Adult Cochlear Implant (EarlyAdultCI)
Early implanted adults, ages 18 to 35 years
Other: Single-Electrode Pulse Train
AIM 2 - Stimuli will be presented on one of three electrodes (apical, middle, and basal) at an amplitude between 10 and 100% dynamic range in µAs in 10% dynamic range steps. Stimulation will be delivered at a rate of 1000 pps. The process will be repeated in random order until 20 loudness estimates are obtained for each stimulus (3 electrodes x 2 rates x 10 amplitudes) for each subject. The dynamic range will be determined by measuring the maximum acceptable loudness (MAL) and threshold for each of the stimuli. MAL will be measured by slowly raising the current level for each stimulus until the subject reports that it is as loud as they are willing to accept without becoming uncomfortably loud.
Other: Sound coding strategy.
Aim3 - Spectral-temporally modulated ripple test (SMRT), Quick Spectral Modulation Detection (QSMD), Modulation Detection, Gap Detection. CNC words will be set in quiet and Az-Bio/BabyBio sentences in quiet and multi-talker babble (+10 and +5 dB SNR) using both the subject's clinical map and the new reduced channels map. Tests will be presented in the soundfield at 60 dB SPL
Experimental: Cochlear Implant (CI)
CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral)
Other: Electric-only spectral resolution
Aim 1- Spectral resolution will be tested using frequency allocations consisting of the full default clinical range as well as the subject's clinical frequency allocation if they differ. For Hybrid electrode users in which electrode contacts are closer in proximity in the cochlea, maps with a frequency allocation of 938-7938 Hz will also be tested in that it will closely approximate the frequency spacing of a Nucleus Contour Advance electrode array. Spectral resolution will be measured with three repetitions of the SMRT and one repetition of the QSMD test. Testing will be presented at 60 dB SPL in the soundfield with the acoustic ear plugged and muffed.
Active Comparator: Normal Hearing Children (NHC)
Ages 7-17 years, Control Group
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks
AIM 1 - MDT will be set at 150 Hz. Testing will be conducted in soundfield in a sound booth at 60 dB Sound Pressure Level (SPL) while the participant listens with both implants adjusted to user setting.
Active Comparator: Normal Hearing Adults (NHA)
18+ years, Control Group
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks
AIM 1 - MDT will be set at 150 Hz. Testing will be conducted in soundfield in a sound booth at 60 dB Sound Pressure Level (SPL) while the participant listens with both implants adjusted to user setting.

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
Change in loudness growth in Cochlear Implant participants
Time Frame: Baseline Visit (Day 1) , Visit week 10
Power functions will be fit for each of the loudness growth curves. Data will be analyzed using a mixed-design ANOVA with the two groups as the between-subjects factor and electrode and rate as within-subject factors.
Baseline Visit (Day 1) , Visit week 10
Change in temporal resolution in Cochlear implant participants
Time Frame: Baseline Visit (Day 1) , Visit week 10
A mixed-effect ANOVA will be conducted to determine if there is an effect of age group (children vs adults) and hearing condition (CI vs NH) for both modulation detection and gap detection tasks. Post-hoc two-sample t-tests will compare differences between NH and CI children as well as NH and CI adults. Post-hoc paired t-tests will compare differences between adults and children for both the NH and the CI populations.
Baseline Visit (Day 1) , Visit week 10
Change in spectral resolution in Cochlear implant participants
Time Frame: Baseline Visit (Day 1) , Visit week 10
A one-way ANOVA will be used to calculate the differences between the four groups. If significant, post-hoc t-tests will be performed using Rom's modified Bonferroni Type I error correction.
Baseline Visit (Day 1) , Visit week 10
Difference in performance between the reduced channel map and the full map
Time Frame: Baseline Visit (Day 1) , Visit week 10
A mixed-design ANOVA will be conducted for each of the tests with subject population as the between-subjects factor and sound coding strategy as the within-subjects factor
Baseline Visit (Day 1) , Visit week 10

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.
NYU Langone Health

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: David M Landsberger, MD, NYU Langone Health

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.
July 12, 2018

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.
January 1, 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.
January 1, 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).
January 10, 2022

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.
January 10, 2022

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.
January 24, 2022

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.
March 4, 2026

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.
March 2, 2026

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.
March 1, 2026

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.
  • 18-00437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. The investigator who proposed to use the data. The investigator who proposed to use the data.

IPD Sharing Access Criteria

Upon reasonable request.Requests should be directed to natalia.stupak@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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