Hearing LossHATSI-MBNCT05866770
A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
A study testing U8 and N8 sound processor in people with Hearing Loss, run by Cochlear at 3 sites in Australia.
Trial summary
A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for 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
- What is being tested?
- U8 and N8 sound processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesAustralia
- Study dates
- 11 Sep 2023to 30 Jun 2026
- 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
- Eighteen years of age or older
- User of CI600, CI500 or CI24RE implant
- At least 3 months experience with a TGA approved Nucleus cochlear implant in at least one ear
- Fluent speaker of English
- A word speech recognition score of 20% or more when using the cochlear implant alone*
- Willing and able to provide written informed consent *This can be based on clinical data if collected within the last 12 months
Who cannot join
- 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 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
3 sites in 1 country.
Australia3 sites
HEARnet Clinical Studies
Carlton, Victoria, 3053
Cochlear Melbourne
Melbourne E., melbourne, 3002
Cochlear Macquarie
Sydney, New South Wales, 2113
About this study
Official title: A Feasibility, Prospective, Multi-centre, Repeated Measures Investigation Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients
Read the detailed description
The Research System is comprised of several components: the processing unit, fitting software and accessories. The sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation. The application of hearing aid technologies to Cochlear Implant recipients may provide benefit through matching the signal processing technologies across ears for bimodal listeners, enhance performance for CI-alone listening, and potentially lead to efficiency in algorithm development.
- Conditions
- Hearing Loss
- Being tested
- U8, N8 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.
U8Device
The U8 Research System
N8 sound processorDevice
Nucleus 8 sound processor
| Study group | Role | What they receive |
|---|---|---|
| U8 then N8 | Other | Participants in this arm receive U8 followed by N8 Receives: Device: U8; Device: N8 sound processor |
| N8 then U8 | Other | Participants in this arm receive N8 followed by U8 Receives: Device: U8; Device: N8 sound processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent correct monosyllabic word scores.
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for monosyllabic words in quiet CNC words at 60 dB SPL (sound pressure level)
Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
Measured: 3 months
Adaptive sentence in noise scores (AuSTIN)
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.
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 posted19 May 2023
- Study start11 Sep 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866770
- Sponsor's protocol ID
- AI5837
- Acronym
- HATSI-MB
- Status last verified
- May 2025
- First submitted
- 10 May 2023
- Last updated
- 22 May 2025
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Prospective, Multi-centre, Repeated Measures Investigation Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT05866770
- Acronym / sponsor ID
- HATSI-MB / AI5837
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 May 2023 (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.
A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients
Detailed description
The Research System is comprised of several components: the processing unit, fitting software and accessories. The sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation. The application of hearing aid technologies to Cochlear Implant recipients may provide benefit through matching the signal processing technologies across ears for bimodal listeners, enhance performance for CI-alone listening, and potentially lead to efficiency in algorithm development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U8 then N8 | Other | Device: U8, Device: N8 sound processorParticipants in this arm receive U8 followed by N8 |
| N8 then U8 | Other | Device: U8, Device: N8 sound processorParticipants in this arm receive N8 followed by U8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eighteen years of age or older
- User of CI600, CI500 or CI24RE implant
- At least 3 months experience with a TGA approved Nucleus cochlear implant in at least one ear
- Fluent speaker of English
- A word speech recognition score of 20% or more when using the cochlear implant alone*
Key exclusion criteria (4 listed)
- 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 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 |
|---|---|---|
| U8The U8 Research System | Device | N8 then U8, U8 then N8 |
| N8 sound processorNucleus 8 sound processor | Device | N8 then U8, U8 then N8 |
Primary outcome
Percent correct monosyllabic word scores.
Time frame: 3 months
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for monosyllabic words in quiet CNC words at 60 dB SPL (sound pressure level) Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
Adaptive sentence in noise scores (AuSTIN)
Time frame: 3 months
To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.
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 22 May 2025.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U8 and N8 sound processor in people with Hearing Loss, run by Cochlear at 3 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 6 inclusion and 4 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Percent correct monosyllabic word scores. (time frame: 3 months). 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?
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 22 May 2025.