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New sound processor aims to boost hearing in noise

NCT ID NCT07156461

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new sound processor (Osia 3) helps adults with hearing loss or single-sided deafness hear better than the current model (Osia 2). Twenty-nine adults who already have a bone-anchored implant tried both processors. Researchers measured speech understanding in quiet and noisy settings, and asked participants about sound quality.

What this could mean

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

Active substance
Osia 3 sound processor (device)
What this could lead to
If it works, this could mean better hearing in noise for people with certain types of hearing loss or single-sided deafness.
What could go wrong
This is a small, completed study with only 29 participants, so results may not apply to everyone. The improvement over the older device may be small.

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

29 people

The number who actually took part.

Started

Sep 2025

Finished

Nov 2025

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: * Implanted with a Cochlear Osia Implant (OSI100, OSI200, OSI300) * Conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds up to 65 dB HL (up to 40 dB HL at 0.5 kHz, up to 55 dB HL at 1kHz and up to 65 dB HL at 2 and 4 kHz) or Single-Sided Deafness in the implanted ear. The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and, 3 kHz). * Aged 18 years or older, at time of consent. * Minimum experience of 1 month with the Osia 2 Sound Processor. * Fluent speaker in the language used to assess speech perception performance. * Willing and able to provide written informed consent. Exclusion Criteria: * Ongoing infection at or around the sound processor area. * Bilaterally implanted with a Cochlear Osia Implant. * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. * Use of ototoxic drugs that could be harmful to the hearing, as judged 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 Organisations 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.

conductive hearing loss disorder deafness, unilateral Hearing Loss, Conductive hearing loss, mixed conductive-sensorineural

As listed by the trial registrant

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

Bone conduction Hearing loss, conductive Hearing loss, mixed Single sided deafness

Contacts and locations

Locations

  • Cochlear Americas, Denver Research and Technology Lab

    Denver, Colorado, 80124, United States

  • Cochlear Macquarie, Macquarie University

    Sydney, New South Wales, 2109, Australia

  • HEARnet Clinical Studies

    Melbourne, Victoria, 3010, Australia

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