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Cochlear Implant Speech Processing Study for Deafness

This study is looking at how a new way of programming cochlear implants, called a dynamic focusing strategy, affects how well people hear and understand speech. Researchers want to understand how cochlear implants impact the developing ear and how long it takes adults and children to get used to new implant programs. You might be able to join if you are an adult (18+) or child (3 months+) who speaks American English and uses a cochlear implant from Advanced Bionics, Cochlear, or MED-EL. Success will be measured by changes in how well participants identify vowel sounds over 10 weeks, as well as by looking at how electrical signals spread in the ear and how well people can tell different sounds apart. The current status of this study is unclear, but it plans to enroll 200 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 200 participants, including both adults and children.
What's involved
You will listen with an experimental speech processor. Vowel identification scores will be measured at the beginning of the study and weekly for 10 weeks after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 weeks after the intervention to measure changes in vowel identification scores.

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NCT05867173

Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Recruiting
NAAges 3+Interventional
Massachusetts Eye and Ear Infirmary
~200 participants
Updated 2025-11-26 on ClinicalTrials.gov
What's tested:Experimental Speech Processing Strategy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Slopes of the spread of excitation of the electrically evoked compound action potential responses
Measured over Baseline
+6 more outcomes measured

Conditions

Deafness

Explore related trials

Deafness

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Julie Arenberg · PRINCIPAL_INVESTIGATOR · Massachusetts Eye and Ear

Who to contact

Julie Arenberg
[email protected]
617-807-7904
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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.
Unable to carry out the study protocol or tasks required in the study
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

Exclusion

Inability to provide informed consent

What this trial measures

  • Slopes of the spread of excitation of the electrically evoked compound action potential responsesBaseline

    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.

  • Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.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.

  • Changes in vowel identification scoresBaseline and weekly for 10 weeks after the intervention

    Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.

  • Changes in sentence recognition scoresBaseline and weekly for 10 weeks after the intervention

    Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.

  • Changes in speech-gap detection thresholdsBaseline and weekly for 10 weeks after the intervention

    Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.

  • Changes in phoneme discrimination scoresBaseline and weekly for 10 weeks after the intervention

    Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.

  • Changes in time (weeks) with programming strategyBaseline 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.