Hearing Loss, Bilateral or UnilateralENHANCENCT06642935
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
A study testing Totally implantable cochlear Implant in people with Hearing Loss, Bilateral or Unilateral and Hearing Loss, Sensorineural, run by Cochlear at 1 site in Australia.
Trial summary
This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing hearing without the need of any external parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural, Hearing Loss, Cochlear
- What is being tested?
- Totally implantable cochlear Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Nov 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Victoria Eye and Ear Hospital
Melbourne, Victoria, 3002
About this study
Official title: A Feasibility, Interventional, Prospective Study to Enhance Features and Optimise the Clinical Pathway for the TICI Research System in Adult Cochlear Implant Recipients
This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing hearing without the need of any external parts. This study will explore new ways to process the sound from the implanted microphone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural, Hearing Loss, Cochlear
- Being tested
- Totally implantable cochlear Implant
- Keywords
- cochlear implant, sensorineural hearing loss
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally implantable cochlear ImplantDevice
Totally implantable cochlear Implant
| Study group | Role | What they receive |
|---|---|---|
| Device :TICI G2 Clinical Investigation System | Experimental | Totally implantable cochlear Implant Receives: Device: Totally implantable cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the cochlear implant internal microphone frequency gain response over time
The mean gain (dB) averaged across the frequency range (0.125 to 8kHz) of the internal cochlear implant microphone measured at 1 day, 7 days, 14 days, 21 days, 8 weeks (60 days), 12 weeks (90 days), 52 weeks (12 months) and 77 weeks (18 months) post-implantation surgery
Measured: 1 day, 7 days, 14 days, 21 days, 8 weeks (60 days), 12 weeks (90 days), 52 weeks (12 months) and 77 weeks (18 months) post-implantation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start18 Nov 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral or UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642935
- Sponsor's protocol ID
- AI5848
- Other IDs
- AI5848
- Acronym
- ENHANCE
- Status last verified
- May 2026
- First submitted
- 13 Oct 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Interventional, Prospective Study to Enhance Features and Optimise the Clinical Pathway for the TICI Research System in Adult Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT06642935
- Acronym / sponsor ID
- ENHANCE / AI5848
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural, Hearing Loss, Cochlear
- Keywords
- cochlear implant, sensorineural hearing loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing hearing without the need of any external parts. This study will explore new ways to process the sound from the implanted microphone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device :TICI G2 Clinical Investigation System | Experimental | Device: Totally implantable cochlear ImplantTotally implantable cochlear Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totally implantable cochlear ImplantTotally implantable cochlear Implant | Device | Device :TICI G2 Clinical Investigation System |
Primary outcome
Mean change in the cochlear implant internal microphone frequency gain response over time
Time frame: 1 day, 7 days, 14 days, 21 days, 8 weeks (60 days), 12 weeks (90 days), 52 weeks (12 months) and 77 weeks (18 months) post-implantation surgery
The mean gain (dB) averaged across the frequency range (0.125 to 8kHz) of the internal cochlear implant microphone measured at 1 day, 7 days, 14 days, 21 days, 8 weeks (60 days), 12 weeks (90 days), 52 weeks (12 months) and 77 weeks (18 months) post-implantation surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Bilateral or Unilateral
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
RecruitingObservational study
Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants
Recruiting
Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss
Tinnitus, Hearing Loss, Bilateral or Unilateral
Not yet recruitingObservational study
Hearing Loss and Aid Attitudes in Health Sciences Students
Hearing Loss, Bilateral or Unilateral, Hearing Aid
RecruitingObservational study
Effectiveness of Speech Therapy for Lip-reading in Patients With Hearing Aids: SCED Study
Hearing Loss, Bilateral or Unilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Totally implantable cochlear Implant in people with Hearing Loss, Bilateral or Unilateral and Hearing Loss, Sensorineural, run by Cochlear at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the cochlear implant internal microphone frequency gain response over time (time frame: 1 day, 7 days, 14 days, 21 days, 8 weeks (60 days), 12 weeks (90 days), 52 weeks (12 months) and 77 weeks (18 months) post-implantation surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.