A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
NCT ID: NCT05003674
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2022-11-28
2025-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Adults cochlear implant recipients receiving alternative stimulation strategy
ACE strategy, 8 maxima, alternative mode
Focused stimulation strategy
Investigational focused stimulation strategy
Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy.
ACE strategy, 8 maxima, monopolar mode.
ACE stimulation strategy
Standard of care stimulation strategy
Interventions
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Focused stimulation strategy
Investigational focused stimulation strategy
ACE stimulation strategy
Standard of care stimulation strategy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AI5782
Identifier Type: -
Identifier Source: org_study_id
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