Cochlear Implant UsersSTREAMNCT07262827
Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
A study testing Nucleus 8 Sound Processor streaming via MultiMic+, Nucleus 8 Sound Processor microphones and Nucleus 8 Sound Processor streaming via Roger 20 in people with Cochlear Implant Users, run by Cochlear at 1 site in Australia.
Trial summary
This study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant Users
- What is being tested?
- Nucleus 8 Sound Processor streaming via MultiMic+, Nucleus 8 Sound Processor microphones and Nucleus 8 Sound Processor streaming via Roger 20
- 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
- 12 Mar 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Implanted with at least one of the CI1000 Series, CI600 Series, CI500 Series, Freedom Series or N24 Series cochlear hearing implants.
- At least 3 months experience with a cochlear hearing implant
- Demonstrated ability to score 30% or more at +15 SNR with Cochlear implant alone on a sentence in noise test.
- Willingness to participate in and to comply with all requirements of the protocol
- Fluent speaker in English as determined by the investigator
- Willing and able to provide written informed consent.
Who cannot join
- Additional disabilities that would prevent participation in evaluations
- Unrealistic expectations on the part of the participant, 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.
- 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. Contact the study team or a site near you to ask about taking part.
Wei Hong contact
Australia1 site, 1 recruiting
- Recruiting
Cochlear Limited
Sydney, New South Wales, 2109
Wei Hong, whong@cochlear.com
About this study
Official title: A Pre-market, Prospective, Within-subject, Open-label, Interventional Investigation of Acceptance and Performance of Wireless Streaming Via Low Energy Audio Introduced Into the Firmware of the Nucleus 8 and Kanso 3 Sound Processors Worn by Experienced Adult Cochlear Implant Recipients
This study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor. The investigation includes actual use (take home) of LE Audio firmware releases and the new GN ReSound LE Audio wireless accessories, including the Multi-Mic+, for use in the real-world. Using the final versions of firmware, speech perception performance in noise will be investigated using the Nucleus 8 and Kanso 3 Sound Processors streaming via a Multi-Mic+.
- Conditions
- Cochlear Implant Users
- Being tested
- Nucleus 8 Sound Processor streaming via MultiMic+, Nucleus 8 Sound Processor microphones, Nucleus 8 Sound Processor streaming via Roger 20, Kanso 3 Sound Processor streaming via Multi-Mic+, Kanso 3 Sound Processor microphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleus 8 Sound Processor streaming via MultiMic+Device
The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory.
Nucleus 8 Sound Processor microphonesDevice
Nucleus 8 Sound Processor streaming via the Nucleus 8 Sound Processor microphones (SCAN 2).
Nucleus 8 Sound Processor streaming via Roger 20Device
Nucleus 8 Sound Processor streaming audio via the Roger 20 wireless microphone accessory.
Kanso 3 Sound Processor streaming via Multi-Mic+Device
Kanso 3 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory. This includes the Kanso 3 Nexa Sound Processor.
Kanso 3 Sound Processor microphoneDevice
Kanso 3 Sound Processor streaming audio via the Kanso 3 Sound Processor microphones (SCAN 2). This includes the Kanso 3 Nexa Sound Processor.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Participants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with LE Audio investigational firmware. Comparisons will be made within-participant with repeated measures for each of the speech perception scores in noise conditions. Receives: Device: Nucleus 8 Sound Processor streaming via MultiMic+; Device: Nucleus 8 Sound Processor microphones; Device: Nucleus 8 Sound Processor streaming via Roger 20; Device: Kanso 3 Sound Processor streaming via Multi-Mic+; Device: Kanso 3 Sound Processor microphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired difference in City University of New York (CUNY) Sentences scores (% words correct) in classroom-like noise between the Nucleus 8 streaming via Multi-Mic+ and Nucleus 8 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL
Measured: At ad-hoc visits between enrolment and 12 months
Secondary outcomes (3)
Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Nucleus 8 streaming via the Multi-Mic+ and Nucleus 8 streaming via the Roger 20 system at -15 dB SNR in 65 dB SPL
Measured: At ad-hoc visits between enrolment and 12 months
Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Kanso 3 streaming via Multi-Mic+ and Kanso 3 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL
Measured: At ad-hoc visits between enrolment and 12 months
Ratings based on the Device Use Questionnaire after a minimum of two weeks actual-use of the new GN ReSound accessories in the real-world environment
The custom device use questionnaire is designed to collect information regarding the participants' experience using the research sound processors with the interventional accessories using a 5-point Likert scale (very satisfied, satisfied, neither dissatisfied nor satisfied, dissatisfied, very dissatisfied)
Measured: At ad-hoc visits between enrolment and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start12 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Implant UsersStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262827
- Sponsor's protocol ID
- CLTD5844
- Acronym
- STREAM
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-market, Prospective, Within-subject, Open-label, Interventional Investigation of Acceptance and Performance of Wireless Streaming Via Low Energy Audio Introduced Into the Firmware of the Nucleus 8 and Kanso 3 Sound Processors Worn by Experienced Adult Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT07262827
- Acronym / sponsor ID
- STREAM / CLTD5844
- Conditions
- Cochlear Implant Users
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 4 Dec 2025 (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 study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor. The investigation includes actual use (take home) of LE Audio firmware releases and the new GN ReSound LE Audio wireless accessories, including the Multi-Mic+, for use in the real-world. Using the final versions of firmware, speech perception performance in noise will be investigated using the Nucleus 8 and Kanso 3 Sound Processors streaming via a Multi-Mic+.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Device: Nucleus 8 Sound Processor streaming via MultiMic+, Device: Nucleus 8 Sound Processor microphones, Device: Nucleus 8 Sound Processor streaming via Roger 20, Device: Kanso 3 Sound Processor streaming via Multi-Mic+, Device: Kanso 3 Sound Processor microphoneParticipants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with LE Audio investigational firmware. Comparisons will be made within-participant with repeated measures for each of the speech perception scores in noise conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Implanted with at least one of the CI1000 Series, CI600 Series, CI500 Series, Freedom Series or N24 Series cochlear hearing implants.
- At least 3 months experience with a cochlear hearing implant
- Demonstrated ability to score 30% or more at +15 SNR with Cochlear implant alone on a sentence in noise test.
- Willingness to participate in and to comply with all requirements of the protocol
Key exclusion criteria (5 listed)
- Additional disabilities that would prevent participation in evaluations
- Unrealistic expectations on the part of the participant, 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.
- 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).
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 8 Sound Processor streaming via MultiMic+The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory. | Device | All Participants |
| Nucleus 8 Sound Processor microphonesNucleus 8 Sound Processor streaming via the Nucleus 8 Sound Processor microphones (SCAN 2). | Device | All Participants |
| Nucleus 8 Sound Processor streaming via Roger 20Nucleus 8 Sound Processor streaming audio via the Roger 20 wireless microphone accessory. | Device | All Participants |
| Kanso 3 Sound Processor streaming via Multi-Mic+Kanso 3 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory. This includes the Kanso 3 Nexa Sound Processor. | Device | All Participants |
| Kanso 3 Sound Processor microphoneKanso 3 Sound Processor streaming audio via the Kanso 3 Sound Processor microphones (SCAN 2). This includes the Kanso 3 Nexa Sound Processor. | Device | All Participants |
Primary outcome
Paired difference in City University of New York (CUNY) Sentences scores (% words correct) in classroom-like noise between the Nucleus 8 streaming via Multi-Mic+ and Nucleus 8 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL
Time frame: At ad-hoc visits between enrolment and 12 months
3 secondary outcomes
Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Nucleus 8 streaming via the Multi-Mic+ and Nucleus 8 streaming via the Roger 20 system at -15 dB SNR in 65 dB SPL
Time frame: At ad-hoc visits between enrolment and 12 months
Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Kanso 3 streaming via Multi-Mic+ and Kanso 3 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL
Time frame: At ad-hoc visits between enrolment and 12 months
Ratings based on the Device Use Questionnaire after a minimum of two weeks actual-use of the new GN ReSound accessories in the real-world environment
Time frame: At ad-hoc visits between enrolment and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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 Cochlear Implant Users
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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.
Wei Hong contact
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 8 Sound Processor streaming via MultiMic+, Nucleus 8 Sound Processor microphones and Nucleus 8 Sound Processor streaming via Roger 20 in people with Cochlear Implant Users, run by Cochlear at 1 site 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 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: looking for participants now, as of the sponsor's last update on 26 Aug 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Hong (whong@cochlear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired difference in City University of New York (CUNY) Sentences scores (% words correct) in classroom-like noise between the Nucleus 8 streaming via Multi-Mic+ and Nucleus 8 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL (time frame: At ad-hoc visits between enrolment and 12 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 26 Aug 2026.