Hearing Loss, Bilateral SensorineuralENTERPRISENCT07139327
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
A study testing Cochlear Implant in people with Hearing Loss, Bilateral Sensorineural, run by Cochlear at 8 sites in 2 countries.
Trial summary
This clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment allowing the option to hear without the need of an external sound processor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Bilateral Sensorineural
- What is being tested?
- Cochlear Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Dec 2025to Oct 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
- Individuals aged 18 years and older at time of consent.
- Clinically established post-linguistic moderately severe to profound sensorineural hearing loss (PTA4 of >55 dB HL), in the ear to be implanted.
- Meets local candidacy criteria for cochlear implantation.
- Compromised functional hearing with a hearing aid in the ear to be implanted, as determined by the investigator.
- Willing to undergo unilateral cochlear implantation.
- Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator
- Direct access to a compatible Smart Phone.
- Willing and able to provide written informed consent.
Who cannot join
- Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
- Candidates with single-sided deafness as determined by the investigator.
- Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
- Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
- Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
- Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.
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- Cochlear ossification, cochlear malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.
- Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.
- Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the participant.
- Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported by the participant, in the ear to be implanted.
- Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the investigator.
- Preexisting skin condition that could jeopardize wound healing, as determined by the investigator e.g., psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.
- Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.
- Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
- Women who are pregnant.
- Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of the investigation.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia6 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Royal Victoria Eye and Ear Hospital
East Melbourne, Victoria, 3002
St Vincent's Private Hospital
East Melbourne, Victoria, 3002
Macquarie University Hospital
Macquarie, New South Wales, 2109
Westmead Private Hospital
Westmead, New South Wales, 2145
Westmead Public Hospital
Westmead, New South Wales, 2145
France2 sites
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, 38700
Centre Hospitalier Universitaire de Lille
Lille, 59000
About this study
Official title: A Pre-market, Prospective, Interventional, Multicenter, Pivotal Study to Evaluate Efficacy and Safety of a Totally Implantable Cochlear Implant System in an Adult Population With Sensorineural Hearing Loss
This clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment allowing the option to hear without the need of an external sound processor. This implant will be tested in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). 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 Sensorineural
- Being tested
- 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.
Cochlear ImplantDevice
TICI G2 Clinical Investigation System
| Study group | Role | What they receive |
|---|---|---|
| TICI G2 Clinical Investigation System | Experimental | Participants will be implanted with the TICI G2 Implant Receives: Device: Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition performance in quiet
Percent correct word score from preimplantation to post-activation
Measured: Preimplantation to 6 months post-activation
Incidence of adverse events and device deficiencies
Frequency and severity of device and procedure-related adverse events, including device deficiencies
Measured: Implantation to 6 and 12 months post-activation
Secondary outcomes (8)
Speech recognition in quiet and noise
Percent correct scores for word tests in quiet and speech reception threshold scores for sentence tests in noise
Measured: Preimplantation to 12 months post-activation
Speech Spatial Qualities questionnaire (SSQ-12)
Speech, Spatial, and Qualities of Hearing Scale Global score (SSQ-12). Scores range from 0 to 10, where higher scores indicate greater ability (less hearing disability).
Measured: Preimplantation to 12 months post-activation
Cochlear Implant Quality of Life Profile (CIQOL-35)
Cochlear implant hearing related quality of life score (CIQOL-35). Scored for six health domains (communication, emotional, entertainment, environment, listening effort, and social) each scaled from 0 to 100, where a higher score indicates better health.
Measured: Preimplantation to 12-months post-activation
Health Utilities Index (HUI 2/3)
Health Utilities Index (HUI 2/3) Global score. Scores range from -0.36 to 1.00, where a negative score represents a state "worse than dead" and a top score of 1.00 is "perfect health"
Measured: Preimplantation to 12 months post-activation
Living with Cochlear Implants Questionnaire (LivCI)
Living with Cochlear Implants Questionnaire (LivCI) evaluates the impact of a hearing device on four domains, Participation (range 0 to 12), Psychosocial \& Wellbeing (range 0 to 21), Stigma (range 0 to 15) and Management \& Aesthetics (range 0 to 18), where a higher domain score indicates positive patient report.
Measured: Preimplantation to 12 months post-activation
Patient Satisfaction Survey
Device satisfaction rating score. Scores range from 1 to 5, where a higher score indicates greater patient satisfaction with the TICI system.
Measured: 6 to 12 months post-activation
Short Form (SF)-36 Health Survey
SF-36 is scored for eight health domains, each scaled from 0 to 100, where a higher score indicates better health.
Measured: 8 to 10 months post-activation
Time on air
Hours of TICI System usage
Measured: Initial activation to 12 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionOct 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 SensorineuralStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139327
- Sponsor's protocol ID
- CLTD5864
- Acronym
- ENTERPRISE
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2025
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-market, Prospective, Interventional, Multicenter, Pivotal Study to Evaluate Efficacy and Safety of a Totally Implantable Cochlear Implant System in an Adult Population With Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT07139327
- Acronym / sponsor ID
- ENTERPRISE / CLTD5864
- Conditions
- Hearing Loss, Bilateral Sensorineural
- Keywords
- cochlear implant, sensorineural hearing loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Aug 2025 (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 examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment allowing the option to hear without the need of an external sound processor. This implant will be tested in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). 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 |
|---|---|---|
| TICI G2 Clinical Investigation System | Experimental | Device: Cochlear ImplantParticipants will be implanted with the TICI G2 Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals aged 18 years and older at time of consent.
- Clinically established post-linguistic moderately severe to profound sensorineural hearing loss (PTA4 of >55 dB HL), in the ear to be implanted.
- Meets local candidacy criteria for cochlear implantation.
- Compromised functional hearing with a hearing aid in the ear to be implanted, as determined by the investigator.
- Willing to undergo unilateral cochlear implantation.
Key exclusion criteria (19 listed)
- Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
- Candidates with single-sided deafness as determined by the investigator.
- Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
- Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
- Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
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 |
|---|---|---|
| Cochlear ImplantTICI G2 Clinical Investigation System | Device | TICI G2 Clinical Investigation System |
Primary outcome
Speech recognition performance in quiet
Time frame: Preimplantation to 6 months post-activation
Percent correct word score from preimplantation to post-activation
Incidence of adverse events and device deficiencies
Time frame: Implantation to 6 and 12 months post-activation
Frequency and severity of device and procedure-related adverse events, including device deficiencies
8 secondary outcomes
Speech recognition in quiet and noise
Time frame: Preimplantation to 12 months post-activation
Speech Spatial Qualities questionnaire (SSQ-12)
Time frame: Preimplantation to 12 months post-activation
Cochlear Implant Quality of Life Profile (CIQOL-35)
Time frame: Preimplantation to 12-months post-activation
Health Utilities Index (HUI 2/3)
Time frame: Preimplantation to 12 months post-activation
Living with Cochlear Implants Questionnaire (LivCI)
Time frame: Preimplantation to 12 months post-activation
Patient Satisfaction Survey
Time frame: 6 to 12 months post-activation
Short Form (SF)-36 Health Survey
Time frame: 8 to 10 months post-activation
Time on air
Time frame: Initial activation to 12 months post-activation
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 8 Sep 2026.
- Individual participant dataSharing planned: No
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Implant in people with Hearing Loss, Bilateral Sensorineural, run by Cochlear at 8 sites in 2 countries.
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 8 inclusion and 19 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, France. 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?
Speech recognition performance in quiet (time frame: Preimplantation to 6 months post-activation). The study lists 2 primary outcomes in all. 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 8 Sep 2026.