Cochlear Implant RecipientsSONORA-MUNCT06867380
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
A study testing Investigational sound coding strategy A, Cochlear default sound coding strategy A and Investigational sound coding strategy B in people with Cochlear Implant Recipients and Hearing Loss, Cochlear, run by Cochlear at 2 sites in Australia.
Trial summary
This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant Recipients, Hearing Loss, Cochlear
- What is being tested?
- Investigational sound coding strategy A, Cochlear default sound coding strategy A and Investigational sound coding strategy B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesAustralia
- Study dates
- 27 May 2025to Apr 2030
- 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
- Users of an approved Nucleus cochlear implant.
- Aged 18 years or older (no upper age limit).
- Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
- Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- Willing and able to provide written informed consent.
Who cannot join
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- 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
2 sites in 1 country.
Australia2 sites
HEARnet Clinical studies
Carlton, Victoria, 3053
Cochlear Melbourne
East Melbourne, Victoria, 3002
About this study
Official title: A Feasibility, Prospective, Repeated-measures Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients: A Master Umbrella Investigation
This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.
- Being tested
- Investigational sound coding strategy A, Cochlear default sound coding strategy A, Investigational sound coding strategy B, Cochlear default sound coding strategy B
- 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.
Investigational sound coding strategy ADevice
SPARC (Stimulation Place and Rate Coding) sound coding strategies
Cochlear default sound coding strategy ADevice
ACE (Advanced Combination Encoder) sound coding strategy
Investigational sound coding strategy BDevice
SPARC (Stimulation Place and Rate Coding) sound coding strategies with focused stimulation.
Cochlear default sound coding strategy BDevice
Cochlear default sound coding strategy ACE (Advanced Combination Encoder) sound coding strategy with focused stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Investigational sound coding strategy/Default sound coding strategy (Sub A) | Experimental | Tested with investigational and default sound coding strategies Receives: Device: Investigational sound coding strategy A; Device: Cochlear default sound coding strategy A |
| Investigational sound coding strategy/Default sound coding strategy (Sub B) | Experimental | Tested with investigational and default sound coding strategies Receives: Device: Investigational sound coding strategy B; Device: Cochlear default sound coding strategy B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN) with speech presented at 65 dB SPL in adaptive 4-talker babble noise, both presented in front of the listener. It is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence. Range: -30dB to +30dB. Lower scores reflect a better outcome.
Measured: 0 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start27 May 2025
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Implant RecipientsStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867380
- Sponsor's protocol ID
- AI5838
- Acronym
- SONORA-MU
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2025
- Last updated
- 23 Oct 2026
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Prospective, Repeated-measures Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients: A Master Umbrella Investigation
- ClinicalTrials.gov ID
- NCT06867380
- Acronym / sponsor ID
- SONORA-MU / AI5838
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 27 May 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 10 Mar 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 will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational sound coding strategy/Default sound coding strategy (Sub A) | Experimental | Device: Investigational sound coding strategy A, Device: Cochlear default sound coding strategy ATested with investigational and default sound coding strategies |
| Investigational sound coding strategy/Default sound coding strategy (Sub B) | Experimental | Device: Investigational sound coding strategy B, Device: Cochlear default sound coding strategy BTested with investigational and default sound coding strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Users of an approved Nucleus cochlear implant.
- Aged 18 years or older (no upper age limit).
- Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
- Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- Willing and able to provide written informed consent.
Key exclusion criteria (5 listed)
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- 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 |
|---|---|---|
| Investigational sound coding strategy ASPARC (Stimulation Place and Rate Coding) sound coding strategies | Device | Investigational sound coding strategy/Default sound coding strategy (Sub A) |
| Cochlear default sound coding strategy AACE (Advanced Combination Encoder) sound coding strategy | Device | Investigational sound coding strategy/Default sound coding strategy (Sub A) |
| Investigational sound coding strategy BSPARC (Stimulation Place and Rate Coding) sound coding strategies with focused stimulation. | Device | Investigational sound coding strategy/Default sound coding strategy (Sub B) |
| Cochlear default sound coding strategy BCochlear default sound coding strategy ACE (Advanced Combination Encoder) sound coding strategy with focused stimulation. | Device | Investigational sound coding strategy/Default sound coding strategy (Sub B) |
Primary outcome
Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy
Time frame: 0 to 12 weeks
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN) with speech presented at 65 dB SPL in adaptive 4-talker babble noise, both presented in front of the listener. It is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence. Range: -30dB to +30dB. Lower scores reflect a better outcome.
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 23 Oct 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational sound coding strategy A, Cochlear default sound coding strategy A and Investigational sound coding strategy B in people with Cochlear Implant Recipients and Hearing Loss, Cochlear, run by Cochlear at 2 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 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: under way, not looking for participants, as of the sponsor's last update on 23 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 2 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?
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?
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 Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy (time frame: 0 to 12 weeks). 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 23 Oct 2026.