Hearing LossSALUTENCT07582198

Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients

A study testing Nucleus 7 Sound Processor and Nucleus 8 Sound Processor in people with Hearing Loss, run by Cochlear at 1 site in United States.

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

The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss
What is being tested?: Nucleus 7 Sound Processor and Nucleus 8 Sound Processor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 20 May 2026to 24 Sep 2026
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

Aged 18 years or older, at time of consent.
Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24R(CA), CI24R(ST) CI24R(CS), CI24M, CI24RE(CA), CI24RE(ST), CI422) in the test ear.
At least 18 active electrodes in the test ear.
At least 6 months experience with a cochlear implant in the test ear.
Able to score 20% or more at +10 dB SNR with CI alone on an S0N0 sentence in-noise test in the test ear.
Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.

Show all 9Show fewer

Candidate is a fluent speaker in the language used to assess speech perception performance.
Direct access to a compatible smartphone.
Willing and able to provide written informed consent.

Who cannot join

Recipients with single-sided deafness as determined by the Investigator.
Additional disabilities that would prevent participation in evaluations.
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
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 Organizations 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 Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).

Trial locations and contacts

1 site in 1 country.

United States1 site

Denver Research and Technology Lab
Lone Tree, Colorado, 80124

Other trials in United States

About this study

Official title: A Post-market Interventional, Prospective, Open-label, Multi-center, Clinical Investigation of Hearing Outcomes With the Nucleus 8 Sound Processor and Nucleus 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients

The study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community.

Participants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.

Conditions: Hearing Loss
Being tested: Nucleus 7 Sound Processor, Nucleus 8 Sound Processor
Medical subject headings: Hearing Loss

What participants receive

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

Nucleus 7 Sound ProcessorDevice
While the user can turn ForwardFocus on from any program in the Nucleus 7 Sound Processor, for the duration of this study, SCAN will be used as the default program and ForwardFocus will be turned on for testing. This setting will be referred to as SCAN ForwardFocus (SCAN FF).
Nucleus 8 Sound ProcessorDevice
Nucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.

Study groups in NCT07582198
Study group	Role	What they receive
Veterans	Experimental	Not described Receives: Device: Nucleus 7 Sound Processor; Device: Nucleus 8 Sound Processor
Non-veterans	Experimental	Not described Receives: Device: Nucleus 7 Sound Processor; Device: Nucleus 8 Sound Processor

What is being measured

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

Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N90 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Measured: Week 2 and week 4

Secondary outcomes (9)

Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S90N180 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Measured: Week 2 and week 4
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N180 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Measured: Week 2 and week 4
Paired difference in AzBio improvement (percentage-point change) for the Nucleus 8 Sound Processor (SCAN 2 FF minus SCAN 2) compared to the Nucleus 7 Sound Processor (SCAN FF minus SCAN) in the S0N180 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Measured: Week 2 and week 4
Paired difference in CNC percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
The consonant-nucleus-consonant (CNC) monosyllabic word test will be used to assess speech perception of words in quiet. The test consists of 10 recorded lists of 50 monosyllabic words, produced by a male talker.
Measured: Week 2 and week 4
Paired difference in AzBio percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Measured: Week 2 and week 4
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N0 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Measured: Week 2 and week 4
Proportion of participants preferring each sound processor in various listening domains
The Device Preference Questionnaire is a custom self-assessment to evaluate participants' preference between the Nucleus 8 and Nucleus 7 Sound Processors, or "no preference".
Measured: Week 4
Mean difference in SSQ-12 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
The SSQ-12 is a validated 12-item abbreviated form of the Speech, Spatial, and Qualities of Hearing scale that measures self-reported hearing ability across speech, spatial, and sound quality domains, with each item rated from 0 (poor) to 10 (excellent). Total scores are calculated by averaging responses across relevant items.
Measured: Week 2 and Week 4
Mean difference in VFS-A-10 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
The Vanderbilt Fatigue Scale-10-Item Adult (VFS-A-10) is a validated 10-item subjective scale designed to assess listening-related fatigue in adults with hearing loss. The scale provides a total score based on all 10 questions rated on a Likert scale from 0 (no listening-related fatigue) to 4 (severe listening-related fatigue).
Measured: Week 2 and Week 4

Timeline

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

20 May 202624 Sep 2026

First posted12 May 2026
Study start20 May 2026
Primary completion24 Sep 2026
Study completion24 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hearing LossStudies 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: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07582198
Sponsor's protocol ID: CAM02835
Acronym: SALUTE
Status last verified: Oct 2026
First submitted: 6 May 2026
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
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

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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-market Interventional, Prospective, Open-label, Multi-center, Clinical Investigation of Hearing Outcomes With the Nucleus 8 Sound Processor and Nucleus 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients
ClinicalTrials.gov ID: NCT07582198
Acronym / sponsor ID: SALUTE / CAM02835
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Study start: 20 May 2026 (actual)
Primary completion: 24 Sep 2026 (actual)
Study completion: 24 Sep 2026 (actual)
First posted: 12 May 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Veterans	Experimental	Device: Nucleus 7 Sound Processor, Device: Nucleus 8 Sound Processor
Non-veterans	Experimental	Device: Nucleus 7 Sound Processor, Device: Nucleus 8 Sound Processor

Who may qualify

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

Key inclusion criteria (9 listed)

Aged 18 years or older, at time of consent.
Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24R(CA), CI24R(ST) CI24R(CS), CI24M, CI24RE(CA), CI24RE(ST), CI422) in the test ear.
At least 18 active electrodes in the test ear.
At least 6 months experience with a cochlear implant in the test ear.
Able to score 20% or more at +10 dB SNR with CI alone on an S0N0 sentence in-noise test in the test ear.

Key exclusion criteria (7 listed)

Recipients with single-sided deafness as determined by the Investigator.
Additional disabilities that would prevent participation in evaluations.
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
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.

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
Nucleus 7 Sound ProcessorWhile the user can turn ForwardFocus on from any program in the Nucleus 7 Sound Processor, for the duration of this study, SCAN will be used as the default program and ForwardFocus will be turned on for testing. This setting will be referred to as SCAN ForwardFocus (SCAN FF).	Device	Non-veterans, Veterans
Nucleus 8 Sound ProcessorNucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.	Device	Non-veterans, Veterans

Primary outcome

Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N90 spatial configuration
Time frame: Week 2 and week 4
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.

9 secondary outcomes

Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S90N180 spatial configuration
Time frame: Week 2 and week 4
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N180 spatial configuration
Time frame: Week 2 and week 4
Paired difference in AzBio improvement (percentage-point change) for the Nucleus 8 Sound Processor (SCAN 2 FF minus SCAN 2) compared to the Nucleus 7 Sound Processor (SCAN FF minus SCAN) in the S0N180 spatial configuration
Time frame: Week 2 and week 4
Paired difference in CNC percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
Time frame: Week 2 and week 4
Paired difference in AzBio percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
Time frame: Week 2 and week 4
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N0 spatial configuration
Time frame: Week 2 and week 4
Proportion of participants preferring each sound processor in various listening domains
Time frame: Week 4
Mean difference in SSQ-12 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
Time frame: Week 2 and Week 4
Mean difference in VFS-A-10 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
Time frame: Week 2 and Week 4

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 19 Oct 2026.
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

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Enrolling by invitationObservational study
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Recruiting
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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Nucleus 7 Sound Processor and Nucleus 8 Sound Processor in people with Hearing Loss, run by Cochlear at 1 site in United States.

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 9 inclusion and 7 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 19 Oct 2026. 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 United States. 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?

Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N90 spatial configuration (time frame: Week 2 and week 4). 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 NCT07582198.

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 19 Oct 2026.