Actively Recruiting
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
Led by Cochlear · Updated on 2025-11-24
18
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Severe or poorer bilateral sensorineural hearing loss before age 5
- Severe to profound hearing loss for more than 20 years in the ear to be implanted
- Ossification, otosclerosis, malformation, or other cochlear anomalies that prevent full electrode insertion
- Deafness caused by lesions of the acoustic nerve affecting the implanted ear
- Medical or psychological conditions contraindicating anesthesia, surgery, or study participation
- Additional disabilities affecting participation or safety
- Unrealistic expectations about surgery and device benefits or risks
- Desire to use an integrated acoustic component after implantation
- Unable or unwilling to comply with study requirements
- Investigator site personnel affiliated with the study or their immediate families
- Cochlear employees or employees of study contractors
- Current or recent participation in another interventional clinical study within 30 days, unless Cochlear sponsored and deemed non-impacting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal Victoria Eye and Ear Hospital
Melbourne, Victoria, Australia, 3002
Actively Recruiting
Research Team
N
Niva Shrestha Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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