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NCT Number: NCT05867173

Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

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.

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Key information

Conditions

Deafness Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

3 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass Eye and Ear, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Speech Processing Strategy

Other

Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Age

    Time frame: Age at baseline

    A secondary age analysis on all outcome measures will be applied.

  2. 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.

  3. 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.

  4. 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

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Arenberg

CONTACT

[email protected]

617-807-7904

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Collaborators

  • Boston Children's Hospital
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 19, 2023
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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