Invisible hearing: new cochlear implant needs no external parts
NCT ID NCT06642935
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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18 people
The number who actually took part.
- Started
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Nov 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.
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