A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults (ENTERPRISE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hearing Loss, Bilateral Sensorineural
• Intervention / Treatment: Device: Cochlear Implant

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Macquarie, New South Wales, Australia, 2109
      • Macquarie University Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Private Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Public Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • St Vincent's Private Hospital
    • East Melbourne, Victoria, Australia, 3002
      • Royal Victoria Eye and Ear Hospital
• France
  • La Tronche, France, 38700
    • Centre Hospitalier Universitaire Grenoble Alpes
  • Lille, France, 59000
    • Centre Hospitalier Universitaire de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TICI G2 Clinical Investigation System; Participants will be implanted with the TICI G2 Implant	Device: Cochlear Implant; TICI G2 Clinical Investigation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech recognition performance in quiet	Percent correct word score from preimplantation to post-activation	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	Implantation to 6 and 12 months post-activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech recognition in quiet and noise	Percent correct scores for word tests in quiet and speech reception threshold scores for sentence tests in noise	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).	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.	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"	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.	Preimplantation 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.	8 to 10 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.	6 to 12 months post-activation
Time on air	Hours of TICI System usage	Initial activation to 12 months post-activation

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 17, 2025
• First Submitted That Met QC Criteria: August 17, 2025
• First Posted (Actual): August 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cochlear implant; sensorineural hearing loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss; Hearing Loss, Sensorineural; Equipment and Supplies; Electrodes; Electrical Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants; Neural Prostheses; Implantable Neurostimulators; Hearing Aids; Sensory Aids; Cochlear Implants
• Other Study ID Numbers: CLTD5864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No