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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

TREATMENT

Phase

Trial ID

NCT05003674

Intervention or treatment

DEVICE: Focused stimulation strategy

DEVICE: ACE stimulation strategy

Conditions

• Hearing Impairment

Condition: Hearing Impairment
DEVICE: Focused stimulation strategy and other drugs
Deakin, Australian Capital Territory, Australia and more
Sponsor: Cochlear

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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

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/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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)	Not Specified	7 months

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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