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

Last updated: April 8, 2025
Sponsor: Cochlear
Overall Status: Completed

Phase

N/A

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

Focused stimulation strategy

ACE stimulation strategy

Clinical Study ID

NCT05003674
AI5782
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults 18 years of age or older.

  2. Candidate for unilateral cochlear implant with Slim Modiolar electrode array asdetermined by the implanting centre.

  3. English spoken as a primary language.

  4. Willingness to comply with all investigational requirements.

  5. Willing and able to provide written informed consent.

Exclusion

Exclusion Criteria:

  1. Previous or existing cochlear-implant recipient.

  2. Evidence of severe or greater sensorineural hearing loss prior to five years of age.

  3. Open-set pre-operative word score > 70% in the contralateral ear.

  4. Duration of severe to profound hearing loss > 20 years in the ear to be implanted.

  5. Adults with functional acoustic hearing in the ear to be implanted who desire to usean acoustic component in the implanted ear.

  6. Ossification or other cochlear anomaly that might prevent complete insertion of theelectrode array.

  7. Hearing loss of neural or central origin.

  8. Medical or psychological conditions that would contraindicate undergoing surgery.

  9. Women who are pregnant.

  10. Additional handicaps that would prevent or restrict participation in theaudiological evaluations.

  11. Unrealistic expectations on the part of the subject regarding the possible benefits,risks, and limitations that are inherent to the surgical procedure and prostheticdevice.

  12. Inability or unwillingness to use a hand-held device to control the sound processorand to collect test and survey data.

  13. Unable or unwilling to comply with the requirements of the clinical investigation asdetermined by the Investigator.

  14. Investigator site personnel directly affiliated with this study and/or theirimmediate families; immediate family is defined as a spouse, parent, child, orsibling.

  15. Cochlear employees or employees of Contract Research Organisations or contractorsengaged by Cochlear for the purposes of this investigation.

  16. Currently participating, or participated within the last 30 days, in anotherinterventional clinical investigation/trial involving an investigational drug ordevice.

Study Design

Total Participants: 19
Treatment Group(s): 2
Primary Treatment: Focused stimulation strategy
Phase:
Study Start date:
November 28, 2022
Estimated Completion Date:
April 07, 2025

Study Description

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.

Connect with a study center

  • NextSense - Deakin

    Deakin, Australian Capital Territory 2600
    Australia

    Site Not Available

  • NextSense - Broadmeadow

    Broadmeadow, New South Wales 2292
    Australia

    Site Not Available

  • Royal Victorian Eye and Ear Hospital

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • St Vincent's Private Hospital

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

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