Hearing ImpairmentSUNRISE-MUNCT07763873
A Study Examining Acceptability of Auditory Implant Fitting Software Technologies
A study testing Investigational Software in people with Hearing Impairment, run by Cochlear at 2 sites in 2 countries.
Trial summary
Auditory implant fitting software is used by hearing healthcare professionals to adjust and optimize hearing implant systems for people with hearing loss. While these software tools are carefully tested before they are released, some challenges may only become apparent when they are used in everyday clinical practice. 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?
- Investigational Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2026to Jun 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
- Implanted with an auditory implant in one or both ears.
- Aged 18 years or older.
- Willing and able to provide written informed consent.
- Tertiary qualification in a hearing healthcare discipline recognised for auditory implant or hearing aid fitting
- At least 2 months' experience working with people with hearing impairment.
- Willingness to participate in and to comply with all requirements of the protocol.
Who cannot join
- Additional disabilities that would prevent participation in evaluations.
- 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).
- 1) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Denver Research and Technology Lab
Lone Tree, Colorado, 80124
Baliey Harmon
About this study
Official title: A Pre-Market, Multicentre, Prospective, Open-Label, Within-Subject, Non-Randomised, Interventional Study Examining Acceptability of Auditory Implant Fitting Software Technologies
Auditory implant fitting software is used by hearing healthcare professionals to adjust and optimize hearing implant systems for people with hearing loss. While these software tools are carefully tested before they are released, some challenges may only become apparent when they are used in everyday clinical practice. This research study will assess how well different fitting software technologies work in real-world clinical settings. Information will be collected to better understand how clinicians use the software, identify any usability issues, and find ways to improve the user experience and software design.
- Conditions
- Hearing Impairment
- Being tested
- Investigational Software
- Keywords
- hearing implant
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational SoftwareDevice
Next Generation Fitting software and Nucleus Smart App
| Study group | Role | What they receive |
|---|---|---|
| Investigational Fitting Software and App (Sub A) | Experimental | Investigational Fitting Software and App to be used with a commercially approved sound processor Receives: Device: Investigational Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate clinician task-completion ratings during clinical use of the investigational device under actual-use conditions.
Proportion of task-completion ratings measured on a 5-point ordinal rating scale. The scale is as follows: 1 Unable to complete, 2 Completed after using help, 3 Completed after trying an incorrect option, 4 Completed after some exploration, 5 Completed at first attempt
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763873
- Sponsor's protocol ID
- CLTD03335
- Acronym
- SUNRISE-MU
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Market, Multicentre, Prospective, Open-Label, Within-Subject, Non-Randomised, Interventional Study Examining Acceptability of Auditory Implant Fitting Software Technologies
- ClinicalTrials.gov ID
- NCT07763873
- Acronym / sponsor ID
- SUNRISE-MU / CLTD03335
- Conditions
- Hearing Impairment
- Keywords
- hearing implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 13 Aug 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.
Auditory implant fitting software is used by hearing healthcare professionals to adjust and optimize hearing implant systems for people with hearing loss. While these software tools are carefully tested before they are released, some challenges may only become apparent when they are used in everyday clinical practice. This research study will assess how well different fitting software technologies work in real-world clinical settings. Information will be collected to better understand how clinicians use the software, identify any usability issues, and find ways to improve the user experience and software design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Fitting Software and App (Sub A) | Experimental | Device: Investigational SoftwareInvestigational Fitting Software and App to be used with a commercially approved sound processor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Implanted with an auditory implant in one or both ears.
- Aged 18 years or older.
- Willing and able to provide written informed consent.
- Tertiary qualification in a hearing healthcare discipline recognised for auditory implant or hearing aid fitting
- At least 2 months' experience working with people with hearing impairment.
Key exclusion criteria (6 listed)
- Additional disabilities that would prevent participation in evaluations.
- 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).
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 SoftwareNext Generation Fitting software and Nucleus Smart App | Device | Investigational Fitting Software and App (Sub A) |
Primary outcome
To evaluate clinician task-completion ratings during clinical use of the investigational device under actual-use conditions.
Time frame: 3 months
Proportion of task-completion ratings measured on a 5-point ordinal rating scale. The scale is as follows: 1 Unable to complete, 2 Completed after using help, 3 Completed after trying an incorrect option, 4 Completed after some exploration, 5 Completed at first attempt
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 13 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Software in people with Hearing Impairment, run by Cochlear at 2 sites in 2 countries.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 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 2 sites in United States, 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?
To evaluate clinician task-completion ratings during clinical use of the investigational device under actual-use conditions. (time frame: 3 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 13 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.