Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments

March 24, 2025 updated by: Matthew Goupell, University of Maryland, College Park

Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments - Part 2

Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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.
300

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 Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
      • College Park, Maryland, United States, 20742
        • University of Maryland, College Park

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

For Bilateral Cochlear Implant Users Arm:

Inclusion Criteria:

  • two cochlear implants
  • acquired their hearing loss during adulthood or late childhood (post-lingual onset)
  • native English speaker
  • primarily use oral language
  • at least six months of cochlear implant use
  • Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Exclusion Criteria:

  • people who do not use oral language will be excluded.
  • people with less than six months of device use will be excluded
  • other known disability or neurological disorder
  • women who are pregnant will be excluded from the CT portion of the study
  • people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in either ear will be excluded

For Unilateral Cochlear Implant User with Single-Sided Deafness Arm:

Inclusion Criteria:

  • one cochlear implant in one ear and a second ear with some acoustic hearing
  • acquired their hearing loss during adulthood or late childhood (post-lingual onset)
  • native English speaker
  • primarily use oral language
  • at least six months of cochlear implant use
  • Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Exclusion Criteria:

  • people who do not use oral language will be excluded.
  • people with less than six months of device use will be excluded
  • other known disability or neurological disorder
  • women who are pregnant will be excluded from the CT portion of the study
  • people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in the implanted ear will be excluded
  • people with an acoustic pure-tone average threshold (octave frequencies 250-4000 Hz) > 30 dB HL in the non-implanted ear

For Non-Implanted Listeners with Acoustic Hearing Arm:

Inclusion Criteria:

  • audiometrically normal hearing or near-normal hearing, or mild/moderate hearing loss
  • Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Exclusion Criteria:

  • severe hearing loss
  • other known disability or neurological disorder

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: None (Open Label)

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: Bilateral Cochlear Implant Users
Diagnostic test: Diagnostic tests of cochlear implant or acoustic hearing function
Because the cochlear implant participants in the study will use cochlear implant devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of cochlear implant or acoustic hearing function. This will include perceptual tests of sound localization, speech understanding in noise, binaural fusion, and loudness comparisons.
Behavioral: Targeted aural rehabilitation of the poorer performing ear
Subjects will undergo listening practice on a tablet computer over headphones at home. For the test group, the aural rehabilitation will be targeted at the poorer ear. For the comparison control group, a sham aural rehabilitation will present speech to both ears.
Experimental: Unilateral Cochlear Implant Users with Single-Sided Deafness
Diagnostic test: Diagnostic tests of cochlear implant or acoustic hearing function
Because the cochlear implant participants in the study will use cochlear implant devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of cochlear implant or acoustic hearing function. This will include perceptual tests of sound localization, speech understanding in noise, binaural fusion, and loudness comparisons.
Behavioral: Targeted aural rehabilitation of the poorer performing ear
Subjects will undergo listening practice on a tablet computer over headphones at home. For the test group, the aural rehabilitation will be targeted at the poorer ear. For the comparison control group, a sham aural rehabilitation will present speech to both ears.
Other: Non-Implanted Listeners with Acoustic Hearing
Diagnostic test: Diagnostic tests of cochlear implant or acoustic hearing function
Because the cochlear implant participants in the study will use cochlear implant devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of cochlear implant or acoustic hearing function. This will include perceptual tests of sound localization, speech understanding in noise, binaural fusion, and loudness comparisons.

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
Perceptual responses to sound level
Time Frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Interaural loudness mismatch is defined as the difference between the levels required to balance interaural loudness for sequential stimulation and the levels required to perceptually center a sound image in space for simultaneous stimulation. Participants will respond through pressing virtual buttons on a computer screen. Depending on the condition tested, the sounds will be delivered to one or both ears.
Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Speech understanding in the presence of masking sounds
Time Frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.

Speech understanding will be assessed as the percentage of correctly identified keywords.

Subjects will respond through oral report (where the responses will be scored by the experimenter) or through pressing virtual buttons on a computer screen. The speech sounds will be delivered to one or both ears in the presence of different types of masking sounds. In some cases, signal processing techniques will be used to distort the speech signals to simulate asymmetric hearing abilities.
Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Computed-tomography scan
Time Frame: For CI users: CT scan will be collected from existing medical records with permission or taken after study enrollment. Measurements taken after study enrollment. Not collected for non-implanted listeners with acoustic hearing.
A computed tomography temporal bone scan will be used to image the cochlear structures and cochlear implant electrode array located within. This scan will use a standard clinical scanner, with software updated to extend the Hounsfield range to reduce artifact from the metal contacts of the electrode array. This procedure uses radiographic processes, and therefore presents the subject with a safe but nonzero amount of radiation. The CT scan will be analyzed to provide measurements of each array's insertion depth within the cochlea (in degrees and mm), the distance to the cochlear modiolus (mm), and cochlear scalar location.
For CI users: CT scan will be collected from existing medical records with permission or taken after study enrollment. Measurements taken after study enrollment. Not collected for non-implanted listeners with acoustic hearing.
Electrode impedance (transelectrode impedance matrix)
Time Frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.
This standard clinical measurement will apply a current to one electrode, and measure the resulting induced voltage at each of the other electrodes in the array, one at a time. This process uses low-level electrical stimulation only intended to measure the impedance of the intervening tissues and fluids of the cochlea, and is rarely even perceived by the subject.
Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.
Electrically evoked compound action potentials (ECAPs)
Time Frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.
Electrically evoked compound action potentials (ECAPs) will be measured using clinically-available software to track the growth in auditory nerve response (observed ~0.2-0.8 ms post-stimulus onset) as input level is varied from threshold to the maximal level at which the signal is comfortably loud. The slope of input-output function will be measured ( in microvolts/current unit) for each electrode along the electrode array of each cochlear implant study participant.
Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.

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
Sound Localization
Time Frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Participants' ability to localize a virtual sound source in space will be measured. Subjects will be presented with a broadband sound, with signal processing applied (temporal delays and spectral shaping) to simulate a spatial location of the sound source. Subjects will respond through pressing virtual buttons on a computer screen.
Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Perceptual Fusion
Time Frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Participants' ability to perceptually fuse sounds presented to the ears will be measured. Subjects will be presented with a broadband sound, and will respond through pressing virtual buttons on the computer screen as to (1) how many sounds were heard and where they were perceived inside the head, or (2) which of two mixtures presented contained a larger number of voices.
Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Spectrotemporal ripple sensitivity
Time Frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
This test will be used to evaluate asymmetry in a perceptual measure thought to reflect the peripheral contribution to intersubject variability in speech understanding. This will allow for a baseline from which to ask if the electrophysiological measures provide additional predictive power regarding contralateral disruption beyond the perceptual measures of peripheral asymmetry.
Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.

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.
University of Maryland, College Park

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.
Vanderbilt University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Walter Reed National Military Medical Center

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: Matthew J. Goupell, PhD, University of Maryland, College Park
  • Principal Investigator: Joshua G. Bernstein, PhD, Walter Reed National Military Medical Center; University of Maryland, College Park

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.
December 19, 2023

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.
May 31, 2028

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.
May 31, 2028

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 16, 2024

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.
March 1, 2024

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.
March 12, 2024

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 28, 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.
March 24, 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.
March 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.
  • 2089705
  • 1R01DC020506-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. De-identified data relevant to the project will be disseminated to researchers on and off-campus by request and review of the PI.

After publication, research products from this project will be archived at the Digital Repository at the University of Maryland(DRUM). DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse.

IPD Sharing Time Frame

Following publication, available for at least seven years.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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