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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07139327




Registration number
NCT07139327
Ethics application status
Date submitted
17/08/2025
Date registered
24/08/2025
Date last updated
4/09/2025

Titles & IDs
Public title
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Scientific 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
Secondary ID [1] 0 0
CLTD5864
Universal Trial Number (UTN)
Trial acronym
ENTERPRISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Bilateral Sensorineural 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cochlear Implant

Experimental: TICI G2 Clinical Investigation System - Participants will be implanted with the TICI G2 Implant


Treatment: Devices: Cochlear Implant
TICI G2 Clinical Investigation System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Speech recognition performance in quiet
Timepoint [1] 0 0
Preimplantation to 6 months post-activation
Primary outcome [2] 0 0
Incidence of adverse events and device deficiencies
Timepoint [2] 0 0
Implantation to 6 and 12 months post-activation
Secondary outcome [1] 0 0
Speech recognition in quiet and noise
Timepoint [1] 0 0
Preimplantation to 12 months post-activation
Secondary outcome [2] 0 0
Speech Spatial Qualities questionnaire (SSQ-12)
Timepoint [2] 0 0
Preimplantation to 12 months post-activation
Secondary outcome [3] 0 0
Cochlear Implant Quality of Life Profile (CIQOL-35)
Timepoint [3] 0 0
Preimplantation to 12-months post-activation
Secondary outcome [4] 0 0
Health Utilities Index (HUI 2/3)
Timepoint [4] 0 0
Preimplantation to 12 months post-activation
Secondary outcome [5] 0 0
Living with Cochlear Implants Questionnaire (LivCI)
Timepoint [5] 0 0
Preimplantation to 12 months post-activation
Secondary outcome [6] 0 0
Patient Satisfaction Survey
Timepoint [6] 0 0
6 to 12 months post-activation
Secondary outcome [7] 0 0
Short Form (SF)-36 Health Survey
Timepoint [7] 0 0
8 to 10 months post-activation
Secondary outcome [8] 0 0
Time on air
Timepoint [8] 0 0
Initial activation to 12 months post-activation

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Victoria Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
La Tronche
Country [2] 0 0
France
State/province [2] 0 0
Lille

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
PRS Specialist
Address 0 0
Country 0 0
Phone 0 0
+61 2 9428 6555
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07139327