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Invisible hearing: new cochlear implant needs no external parts

NCT ID NCT06642935

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new totally implantable cochlear implant system (TICI G2) that has a microphone under the skin, so you can hear without any external devices. Researchers will enroll 18 adults with sensorineural hearing loss to see how well the internal microphone works over time and how participants rate their hearing and health. It is a small, early feasibility study to improve the device and the clinical process.

What this could mean

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

Active substance
totally implantable cochlear implant system (TICI G2)
What this could lead to
If successful, this could lead to a fully hidden cochlear implant that works without any external microphone or processor, improving convenience and quality of life for people with hearing loss.
What could go wrong
This is a very early feasibility study with only 18 participants, so results may not apply to everyone. The implantable microphone may not perform as well as external devices, and there are surgical risks.

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

18 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Nov 2027

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: * Aged 18 years or older, at time of consent * Candidate for cochlear implantation as assessed by the implanting clinic * Fluent in English, as determined by the investigator * Willing to participate in and comply with all requirements of the protocol * Willing and able to provide written informed consent Exclusion Criteria: * Severe, or poorer, bilateral sensorineural hearing loss prior to five years of age, as reported by the subject * Duration of severe to profound hearing loss greater than 20 years in the ear to be implanted as reported by the subject or by audiometric history, if available * Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array * Deafness due to lesions of the acoustic nerve affecting the ear to be implanted * Medical or psychological conditions that would contraindicate undergoing anaesthesia, surgery or participation in the clinical investigation, as determined by the investigator * Additional disabilities that may affect the subject's participation or safety during the clinical investigation, as determined by the investigator * Unrealistic expectations on the part of the subject regarding the possible benefits, risks and limitations that are inherent to the surgical procedure and prosthetic device, as determined by the investigator * Desire to use an integrated acoustic component post-implantation * 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 Cochlear sponsored and determined by investigator or Sponsor to not impact this investigation)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Royal Victoria Eye and Ear Hospital

    Melbourne, Victoria, 3002, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.