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A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients

RECRUITING

This feasibility study is designed to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP) stimulation within a group of adult cochlear-implant recipients. Measures of speech recognition, music appreciation, listening effort, quality of life, and real-world assessments will be gathered to determine the most promising benefits for further examination.

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Study details:

Alternative modes of stimulation will be investigated that may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical benefits over MP stimulation. The purpose of this feasibility study is to explore several facets of hearing performance that may show improvements with these alternative modes of stimulation compared to MP stimulation within a group of adult cochlear-implant recipients. Measures of speech recognition, music appreciation, listening effort, quality of life, and real-world assessments will be gathered to determine the most promising benefits for further examination.

Individual neural, psychophysical, cognitive, and electrode placement data will also be obtained to inform questions related to across-subject variability, and practical aspects of power consumption and device fitting will be evaluated.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Adults 18 years of age or older.
  • Candidate for unilateral cochlear implant with Slim Modiolar electrode array as determined by the implanting centre.
  • English spoken as a primary language.
  • Willingness to comply with all investigational requirements.
  • Willing and able to provide written informed consent.
  • Exclusion criteria

  • Previous or existing cochlear-implant recipient.
  • Evidence of severe or greater sensorineural hearing loss prior to five years of age.
  • Open-set pre-operative word score > 70% in the contralateral ear.
  • Duration of severe to profound hearing loss > 20 years in the ear to be implanted.
  • Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component in the implanted ear.
  • Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
  • Hearing loss of neural or central origin.
  • Medical or psychological conditions that would contraindicate undergoing surgery.
  • Women who are pregnant.
  • Additional handicaps that would prevent or restrict participation in the audiological evaluations.
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
  • Inability or unwillingness to use a hand-held device to control the sound processor and to collect test and survey data.
  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
  • Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  • Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
  • Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-11-28

    Primary completion: 2025-01-01

    Study completion finish: 2025-03-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05003674

    Intervention or treatment

    DEVICE: Focused stimulation strategy

    DEVICE: ACE stimulation strategy

    Conditions

    • Hearing Impairment

    Find a site

    Closest Location:

    NextSense - Deakin

    Research sites nearby

    Select from list below to view details:

    • NextSense - Deakin

      Deakin, Australian Capital Territory, Australia

    • NextSense - Broadmeadow

      Broadmeadow, New South Wales, Australia

    • Royal Victorian Eye and Ear Hospital

      East Melbourne, Victoria, Australia

    • St Vincent's Private Hospital

      East Melbourne, Victoria, Australia

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    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?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Adults cochlear implant recipients receiving alternative stimulation strategy
    • ACE strategy, 8 maxima, alternative mode
    DEVICE: Focused stimulation strategy
    • Investigational focused stimulation strategy
    ACTIVE_COMPARATOR: Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy.
    • ACE strategy, 8 maxima, monopolar mode.
    DEVICE: ACE stimulation strategy
    • Standard of care stimulation strategy

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)Not Specified7 months

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients

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