ClinicalTrials.gg
RecruitingNCT06100393PRESENCE-MUUpdated Aug 14, 2026

New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.

An interventional study of Investigational Pre-Processing Algorithm (Sub A) and Cochlear Limited standard-of-care pre-processing algorithms in Hearing Loss, sponsored by Cochlear. Recruiting at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Cochlear · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 efficiently into CI speech processors.

02

Conditions studied

  • Hearing Loss

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03

In context

Hearing Loss

796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.

This study's planned enrollment of 150 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Cochlear is the lead sponsor of 92 studies on the registry; 9 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .
  • ≥3 months post cochlear implant activation

Exclusion criteria

Exclusion Criteria:

  • 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 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)

    Device: Investigational Pre-Processing Algorithm (Sub A) · Device: Cochlear Limited standard-of-care pre-processing algorithms

  • Experimental
    Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)

    Device: Cochlear Limited standard-of-care pre-processing algorithms · Device: Investigational Pre-Processing Algorithm (Sub B)

  • Experimental
    Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)

    Device: Cochlear Limited standard-of-care pre-processing algorithms · Device: Investigational pre-processing algorithm (Sub D)

  • Experimental
    Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)

    Device: Cochlear Limited standard-of-care pre-processing algorithms · Device: Investigational Pre-Processing Algorithm (Sub C)

  • Experimental
    Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E)

    Device: Cochlear Limited standard-of-care pre-processing algorithms · Device: Investigational Pre-Processing Algorithm (Sub E)

Interventions

  • DeviceInvestigational Pre-Processing Algorithm (Sub A)

    DNR algorithm

  • DeviceCochlear Limited standard-of-care pre-processing algorithms

    Standard-of-care sound path as implemented in the N8 system

  • DeviceInvestigational Pre-Processing Algorithm (Sub B)

    Spatial Automation profile

  • DeviceInvestigational pre-processing algorithm (Sub D)

    Microphone miscalibration profile with applied correction method

  • DeviceInvestigational Pre-Processing Algorithm (Sub C)

    Spatial Automation profile and DNR algorithm

  • DeviceInvestigational Pre-Processing Algorithm (Sub E)

    CUSP reference sound path

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day - Immediately post-screening

07

Study locations

1 of 2 sites recruiting
  • Cochlear Melbourne
    Melbourne, Victoria 3002, Australia
    Recruiting
    • Linty McDonald · Principal investigator
  • HEARnet Clinical Studies
    Melbourne, Victoria 3053, Australia
    Active, not recruiting

    Not enrolling at this site.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Oct 2026, 32 months after the start.

Of 125 industry-sponsored interventional studies with no phase under Hearing Loss, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 32 months is above that.

Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2023
First posted
Oct 25, 2023
StartActual
Feb 22, 2024
Primary completionEst.
Oct 31, 2026
CompletionEst.
Oct 31, 2026
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06100393
Lead sponsor
Cochlear
Responsible party
Sponsor
First posted
Oct 25, 2023
Start date
Feb 22, 2024
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Aug 14, 2026

Study contacts

Linty McDonald
Contact
limcdonald@cochlear.com
+61 3 9123 6633

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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