Hearing LossPRESENCE-MUNCT06100393
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
A study testing Investigational Pre-Processing Algorithm (Sub A), Cochlear Limited standard-of-care pre-processing algorithms and Investigational Pre-Processing Algorithm (Sub B) in people with Hearing Loss, run by Cochlear at 2 sites in Australia.
Trial summary
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Clinical Investigation will be comprised of several arms which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them… 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?
- Investigational Pre-Processing Algorithm (Sub A), Cochlear Limited standard-of-care pre-processing algorithms and Investigational Pre-Processing Algorithm (Sub B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesAustralia
- Study dates
- 22 Feb 2024to 31 Oct 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
- User of an approved Nucleus cochlear implant.
- User of the ACE (Advanced Combination Encoder) sound processing strategy.
- Aged 18 years or older (no upper age limit).
- Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.*
- Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- Willing and able to provide written informed consent.
- ≥3 months post cochlear implant activation
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 the investigator's 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 1 recruiting
- Recruiting
Cochlear Melbourne
Melbourne, Victoria, 3002
Linty McDonald
- Active, not recruiting
HEARnet Clinical Studies
Melbourne, Victoria, 3053
About this study
Official title: A Feasibility, Prospective, Repeated-measures Investigation of Hearing Outcomes With New Pre-processing Speech Enhancement Algorithms Compared to Standard-of-care Algorithms in Adult Cochlear Implant Recipients
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Clinical Investigation will be comprised of several arms which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.
- Conditions
- Hearing Loss
- Being tested
- Investigational Pre-Processing Algorithm (Sub A), Cochlear Limited standard-of-care pre-processing algorithms, Investigational Pre-Processing Algorithm (Sub B), Investigational pre-processing algorithm (Sub D), Investigational Pre-Processing Algorithm (Sub C)
- 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 Pre-Processing Algorithm (Sub A)Device
DNR algorithm
Cochlear Limited standard-of-care pre-processing algorithmsDevice
Standard-of-care sound path as implemented in the N8 system
Investigational Pre-Processing Algorithm (Sub B)Device
Spatial Automation profile
Investigational pre-processing algorithm (Sub D)Device
Microphone miscalibration profile with applied correction method
Investigational Pre-Processing Algorithm (Sub C)Device
Spatial Automation profile and DNR algorithm
Investigational Pre-Processing Algorithm (Sub E)Device
CUSP reference sound path
| Study group | Role | What they receive |
|---|---|---|
| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A) | Experimental | Not described Receives: Device: Investigational Pre-Processing Algorithm (Sub A); Device: Cochlear Limited standard-of-care pre-processing algorithms |
| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B) | Experimental | Not described Receives: Device: Cochlear Limited standard-of-care pre-processing algorithms; Device: Investigational Pre-Processing Algorithm (Sub B) |
| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D) | Experimental | Not described Receives: Device: Cochlear Limited standard-of-care pre-processing algorithms; Device: Investigational pre-processing algorithm (Sub D) |
| Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C) | Experimental | Not described Receives: Device: Cochlear Limited standard-of-care pre-processing algorithms; Device: Investigational Pre-Processing Algorithm (Sub C) |
| Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E) | Experimental | Not described Receives: Device: Cochlear Limited standard-of-care pre-processing algorithms; Device: Investigational Pre-Processing Algorithm (Sub E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Australian Sentence Test in Noise (AuSTIN)
To determine whether the research algorithm provides non-inferior performance to the standard-of-care algorithm for sentences in noise using an adaptive sentence test in noise scores.
Scoring: AuSTIN 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: 1 day - Immediately post-screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start22 Feb 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 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.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100393
- Sponsor's protocol ID
- AI5842
- Acronym
- PRESENCE-MU
- Status last verified
- May 2026
- First submitted
- 2 Oct 2023
- Last updated
- 14 Aug 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Prospective, Repeated-measures Investigation of Hearing Outcomes With New Pre-processing Speech Enhancement Algorithms Compared to Standard-of-care Algorithms in Adult Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT06100393
- Acronym / sponsor ID
- PRESENCE-MU / AI5842
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 25 Oct 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.
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Clinical Investigation will be comprised of several arms which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A) | Experimental | Device: Investigational Pre-Processing Algorithm (Sub A), Device: Cochlear Limited standard-of-care pre-processing algorithms |
| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B) | Experimental | Device: Cochlear Limited standard-of-care pre-processing algorithms, Device: Investigational Pre-Processing Algorithm (Sub B) |
| Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D) | Experimental | Device: Cochlear Limited standard-of-care pre-processing algorithms, Device: Investigational pre-processing algorithm (Sub D) |
| Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C) | Experimental | Device: Cochlear Limited standard-of-care pre-processing algorithms, Device: Investigational Pre-Processing Algorithm (Sub C) |
| Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E) | Experimental | Device: Cochlear Limited standard-of-care pre-processing algorithms, Device: Investigational Pre-Processing Algorithm (Sub E) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- User of an approved Nucleus cochlear implant.
- User of the ACE (Advanced Combination Encoder) sound processing strategy.
- Aged 18 years or older (no upper age limit).
- Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.*
- Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
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 the investigator's 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 |
|---|---|---|
| Investigational Pre-Processing Algorithm (Sub A)DNR algorithm | Device | Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A) |
| Cochlear Limited standard-of-care pre-processing algorithmsStandard-of-care sound path as implemented in the N8 system | Device | Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E), Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A), Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B), Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D), Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C) |
| Investigational Pre-Processing Algorithm (Sub B)Spatial Automation profile | Device | Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B) |
| Investigational pre-processing algorithm (Sub D)Microphone miscalibration profile with applied correction method | Device | Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D) |
| Investigational Pre-Processing Algorithm (Sub C)Spatial Automation profile and DNR algorithm | Device | Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C) |
| Investigational Pre-Processing Algorithm (Sub E)CUSP reference sound path | Device | Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E) |
Primary outcome
Australian Sentence Test in Noise (AuSTIN)
Time frame: 1 day - Immediately post-screening
To determine whether the research algorithm provides non-inferior performance to the standard-of-care algorithm for sentences in noise using an adaptive sentence test in noise scores. Scoring: AuSTIN 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 14 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.
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 Pre-Processing Algorithm (Sub A), Cochlear Limited standard-of-care pre-processing algorithms and Investigational Pre-Processing Algorithm (Sub B) in people with Hearing Loss, 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 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 14 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 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 Linty McDonald (+61 3 9123 6633, limcdonald@cochlear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Australian Sentence Test in Noise (AuSTIN) (time frame: 1 day - Immediately post-screening). 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 14 Aug 2026.