Hearing Loss, SensorineuralDUALNCT06298396

Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients

A study testing Program using default MAP, Program using low-power 1 (LP1) MAP and Program using low-power 2 (LP2) MAP in people with Hearing Loss, Sensorineural, run by Cochlear at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss, Sensorineural
What is being tested?: Program using default MAP, Program using low-power 1 (LP1) MAP and Program using low-power 2 (LP2) MAP
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteAustralia
Study dates: 27 May 2024to 16 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422)
At least three months after activation of the cochlear implant.
Eighteen years or older at the time of consent.
User of 900Hz ACE (Advanced Combination Encoder) strategy MAP.
Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear.
Fluent speaker in English.
Willing and able to provide written informed consent.

Who cannot join

One or more electrodes turned off in the MAP used regularly.
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.
Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Trial locations and contacts

1 site in 1 country.

Australia1 site

Cochlear Macquarie
Macquarie Park, New South Wales, 2109

Other trials in Australia

About this study

Official title: A Prospective, Single Centre, Single-blinded, Within-subject Investigation, on the Effect of Stimulation Parameter Changes, and Monopolar and Dual-electrode Mode Changes, on Speech Perception in Experienced Adult Cochlear Implant Recipients

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

Read the detailed description

Performance of four programs (MAPs), each with a different rate, PW and stimulation mode were evaluated, all using 8 maxima: (i) 900 Hz rate, 25 µs PW Default (ii) 900 Hz rate, 50 µs PW LP1, (iii) 500 Hz rate, 100 µs PW LP2 all using Monopolar stimulation mode, and (iv) 500 Hz rate, 100 µs PW using an investigational stimulation mode LP3

Conditions: Hearing Loss, Sensorineural
Being tested: Program using default MAP, Program using low-power 1 (LP1) MAP, Program using low-power 2 (LP2) MAP, Program using low-power 3 (LP3) MAP
Keywords: Cochlear implant, Sensorineural hearing loss, Programming, Speech perception
Medical subject headings: Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Program using default MAPDevice
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 1 (LP1) MAPDevice
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 2 (LP2) MAPDevice
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 3 (LP3) MAPDevice
Each MAP uses a specific combination of stimulation parameters and electrode mode.

Study groups in NCT06298396
Study group	Role	What they receive
MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors	Experimental	Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP. Receives: Device: Program using default MAP; Device: Program using low-power 1 (LP1) MAP; Device: Program using low-power 2 (LP2) MAP; Device: Program using low-power 3 (LP3) MAP

What is being measured

The primary outcome is the main question the study is designed to answer.

Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet
Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words.
The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions.
The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome.
An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.
Measured: 10 participants completed this test at Week 4, and 10 participants completed this at week 8
Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise
Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences.
The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome.
An average SRT score for each MAP was calculated by combining the data from the specified timepoints.
Measured: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8

Secondary outcomes (5)

Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet
Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words.
The goal of speech perception assessment in quiet was to compare % words correct for each MAP.
The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome.
An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.
Measured: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise
Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences.
The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome.
An average SRT score for each MAP was calculated by combining the data from the specified timepoints.
Measured: 10 participants completed this test at Week 4, and 10 participants completed this at week 8
Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet
Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words.
The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions.
The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome.
An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.
Measured: 10 participants completed this test at Week 4, and 10 participants completed this at week 8
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise
Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences.
The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome.
An average SRT score for each MAP was calculated by combining the data from the specified timepoints.
Measured: 10 participants completed this test with at Week 4 and 10 participants completed this at week 8
Switching Acceptability Rating Between LP2 and LP3 MAPs
Participants rated the sound quality when switching between the LP2 and LP3 MAPs with the investigator asking the question: How does the sound quality of the new program compare with the previous program in terms of sound quality? The possible responses being "very different, somewhat different, similar, or the same". The number of participants in each category will be reported.
Measured: 10 participants were evaluated at week 4 and 10 participants were evaluated at week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 202416 Dec 2024

First posted7 Mar 2024
Study start27 May 2024
Primary completion16 Dec 2024
Study completion16 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing Loss, SensorineuralStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06298396
Sponsor's protocol ID: CLTD5853
Acronym: DUAL
Status last verified: Nov 2025
First submitted: 28 Feb 2024
Last updated: 17 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Active, not recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Active, not recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural, Hearing Loss

All Hearing Loss, Sensorineural trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single Centre, Single-blinded, Within-subject Investigation, on the Effect of Stimulation Parameter Changes, and Monopolar and Dual-electrode Mode Changes, on Speech Perception in Experienced Adult Cochlear Implant Recipients
ClinicalTrials.gov ID: NCT06298396
Acronym / sponsor ID: DUAL / CLTD5853
Conditions: Hearing Loss, Sensorineural
Keywords: Cochlear implant, Sensorineural hearing loss, Programming, Speech perception
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Collaborators: Avania
Study start: 27 May 2024 (actual)
Primary completion: 16 Dec 2024 (actual)
Study completion: 16 Dec 2024 (actual)
First posted: 7 Mar 2024 (actual)
Results: Posted 17 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors	Experimental	Device: Program using default MAP, Device: Program using low-power 1 (LP1) MAP, Device: Program using low-power 2 (LP2) MAP, Device: Program using low-power 3 (LP3) MAPParticipants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422)
At least three months after activation of the cochlear implant.
Eighteen years or older at the time of consent.
User of 900Hz ACE (Advanced Combination Encoder) strategy MAP.
Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear.

Key exclusion criteria (5 listed)

One or more electrodes turned off in the MAP used regularly.
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.
Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

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
Program using default MAPEach MAP uses a specific combination of stimulation parameters and electrode mode.	Device	MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors
Program using low-power 1 (LP1) MAPEach MAP uses a specific combination of stimulation parameters and electrode mode.	Device	MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors
Program using low-power 2 (LP2) MAPEach MAP uses a specific combination of stimulation parameters and electrode mode.	Device	MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors
Program using low-power 3 (LP3) MAPEach MAP uses a specific combination of stimulation parameters and electrode mode.	Device	MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors

Primary outcome

Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet
Time frame: 10 participants completed this test at Week 4, and 10 participants completed this at week 8
Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.
Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise
Time frame: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8
Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.

5 secondary outcomes

Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet
Time frame: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise
Time frame: 10 participants completed this test at Week 4, and 10 participants completed this at week 8
Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet
Time frame: 10 participants completed this test at Week 4, and 10 participants completed this at week 8
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise
Time frame: 10 participants completed this test with at Week 4 and 10 participants completed this at week 8
Switching Acceptability Rating Between LP2 and LP3 MAPs
Time frame: 10 participants were evaluated at week 4 and 10 participants were evaluated at week 8

Results and safety

Results posted to the registry on 17 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	20	19

Primary outcome: Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet

Time frame: 10 participants completed this test at Week 4, and 10 participants completed this at week 8. Mean (95% Confidence Interval). Unit: percentage word score

Measure	Sound processor MAP n = 19
Value	-0.05 (-2.92 to 2.81)

Sound processor MAP: Mean Difference (Final Values): -0.05 (95% CI -2.92 to 2.81)

Population analysed: One participant had the default MAP created using a Pulse Width of 37 µs rather than the required 25 µs, so there were 19 paired data points for analysis. All remaining participants were tested with the Default and LP1 MAPs

Primary outcome: Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise

Time frame: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8. Mean (95% Confidence Interval). Unit: dB SRT

Measure	Sound processor MAP n = 19
Value	-0.32 (-0.87 to 0.24)

Sound processor MAP: Mean Difference (Final Values): -0.32 (95% CI -0.87 to 0.24)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each participant was assessed from enrollment to final study visit, approximately 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Related trials for Hearing Loss, Sensorineural

Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
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Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
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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.

Esti Nel principal investigator

Cochlear

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 5 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet (time frame: 10 participants completed this test at Week 4, and 10 participants completed this at week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06298396.

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 17 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.