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New cochlear implant software aims to cut through noise

NCT ID NCT06100393

Symptom relief Sponsor: Cochlear Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests new speech-enhancement software in cochlear implants to help adults with hearing loss understand speech better in noisy places. About 150 adult cochlear implant users will compare the new algorithms to the standard ones. The goal is to see if the new software improves hearing without making things worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
new speech-enhancement algorithms (software) for cochlear implants
What this could lead to
If successful, these algorithms could help cochlear implant users hear speech more clearly in noisy environments, improving daily communication.
What could go wrong
This is an early feasibility study with 150 participants, so results may not apply to all users. The improvements might be small or not noticeable in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 informed consent. * ≥3 months post cochlear implant activation 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 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).

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Conditions

The condition(s) this trial relates to.

hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cochlear Melbourne

    RECRUITING

    Melbourne, Victoria, 3002, Australia

  • HEARnet Clinical Studies

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3053, Australia

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