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

April 8, 2025 updated by: Cochlear

A Feasibility, Prospective, Multi-centre, Repeated-measures Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • 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

  • Australia
    • Australian Capital Territory
      • Deakin, Australian Capital Territory, Australia, 2600
        • NextSense - Deakin
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • NextSense - Broadmeadow
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Royal Victorian Eye and Ear Hospital
      • East Melbourne, Victoria, Australia, 3002
        • St Vincent's Private Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults 18 years of age or older.
  2. Candidate for unilateral cochlear implant with Slim Modiolar electrode array as determined 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 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 use an acoustic component in the implanted ear.
  6. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode 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 the audiological 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 prosthetic device.
  12. Inability or unwillingness to use a hand-held device to control the sound processor and to collect test and survey data.
  13. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
  14. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  15. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
  16. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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 Measures

Outcome Measure
Time Frame
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

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)

November 28, 2022

Primary Completion (Actual)

April 7, 2025

Study Completion (Actual)

April 7, 2025

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI5782

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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