Hearing ImpairmentFOCUSNCT05003674
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
A study testing Focused stimulation strategy and ACE stimulation strategy in people with Hearing Impairment, run by Cochlear at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Focused stimulation strategy and ACE stimulation strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesAustralia
- Study dates
- 28 Nov 2022to 7 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
NextSense - Broadmeadow
Broadmeadow, New South Wales, 2292
NextSense - Deakin
Deakin, Australian Capital Territory, 2600
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002
St Vincent's Private Hospital
East Melbourne, Victoria, 3002
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Impairment
- Being tested
- Focused stimulation strategy, ACE stimulation strategy
- Keywords
- cochlear implantation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused stimulation strategyDevice
Investigational focused stimulation strategy
ACE stimulation strategyDevice
Standard of care stimulation strategy
| Study group | Role | What they receive |
|---|---|---|
| Adults cochlear implant recipients receiving alternative stimulation strategy | Experimental | ACE strategy, 8 maxima, alternative mode Receives: Device: Focused stimulation strategy |
| Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy. | Active comparator | ACE strategy, 8 maxima, monopolar mode. Receives: Device: ACE stimulation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start28 Nov 2022
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003674
- Sponsor's protocol ID
- AI5782
- Acronym
- FOCUS
- Status last verified
- Apr 2025
- First submitted
- 21 Jul 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Prospective, Multi-centre, Repeated-measures Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT05003674
- Acronym / sponsor ID
- FOCUS / AI5782
- Conditions
- Hearing Impairment
- Keywords
- cochlear implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults cochlear implant recipients receiving alternative stimulation strategy | Experimental | Device: Focused stimulation strategyACE strategy, 8 maxima, alternative mode |
| Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy. | Active comparator | Device: ACE stimulation strategyACE strategy, 8 maxima, monopolar mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused stimulation strategyInvestigational focused stimulation strategy | Device | Adults cochlear implant recipients receiving alternative stimulation strategy |
| ACE stimulation strategyStandard of care stimulation strategy | Device | Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy. |
Primary outcome
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused stimulation strategy and ACE stimulation strategy in people with Hearing Impairment, run by Cochlear at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.