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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TICI G2 Clinical Investigation System | Experimental | Participants will be implanted with the TICI G2 Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Implant | Device | TICI G2 Clinical Investigation System |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Macquarie University Hospital |
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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 |
| 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 |
| 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 |
| Time on air | Hours of TICI System usage | Initial activation to 12 months post-activation |
| Macquarie |
| New South Wales |
| 2109 |
| Australia |
| Westmead Private Hospital | Westmead | New South Wales | 2145 | Australia |
| Westmead Public Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Victoria Eye and Ear Hospital | East Melbourne | Victoria | 3002 | Australia |
| St Vincent's Private Hospital | East Melbourne | Victoria | 3002 | Australia |
| Centre Hospitalier Universitaire Grenoble Alpes | La Tronche | 38700 | France |
| Centre Hospitalier Universitaire de Lille | Lille | 59000 | France |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |
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