Actively Recruiting
Study of the Totally Implantable Cochlear Implant TI1132 System to Treat Adults With Sensorineural Hearing Loss
Led by Cochlear · Updated on 2026-07-31
56
Participants Needed
11
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the clinical benefit, performance, and safety of a totally implantable cochlear implant TICI system in adults with sensorineural hearing loss, which is hearing loss caused by damage to the inner ear or auditory nerve. The study is pivotal and pre-market, focusing on how this system, which includes a microphone placed under the skin to detect speech and sounds without any visible external parts, can affect hearing ability and daily life. Participants will be implanted with the TI1132 device, a totally implantable cochlear implant system. The study involves a single group design where all participants receive this investigational implant. The research team will monitor and assess the implants performance and safety over time from the implantation through post-activation periods. During the study, participants will undergo hearing tests and complete questionnaires before implantation and up to 12 months after activation of the device. The tests will measure speech recognition performance in quiet and noise, and various quality of life and hearing questionnaires will evaluate the impact on daily living. Safety will be monitored by tracking adverse events and device issues. The total participation period includes assessments up to 12 months post-activation, with the study completion expected in August 2028.
CONDITIONS
Brief Title
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 years and older at time of consent.
- Clinically established sensorineural hearing loss with a pure-tone average threshold of 70 dB HL or greater in the ear to be implanted.
- Functional hearing with hearing aids in the ear to be implanted is 40% correct or less on a word recognition test.
- Sensorineural hearing loss with a pure-tone average threshold of 30 dB HL or greater in the opposite ear.
- Fluent speaker in the language used for speech perception testing.
- Direct access to a compatible smartphone.
- Willing and able to provide written informed consent.
You will not qualify if you...
- Prior cochlear implantation in either ear or planned cochlear implantation in the opposite ear.
- Single-sided deafness.
- Brain lesions or nerve damage affecting hearing in the implanted ear.
- Middle ear infection at surgery time or within 3 months before enrollment.
- Tympanic membrane perforation or recent ear surgery within 3 months before enrollment.
- Diagnosis of auditory neuropathy in the implanted ear.
- Cochlear abnormalities that prevent full electrode insertion.
- Current cerebrospinal fluid shunts, leaks, or skull fractures.
- Severe hearing loss before age 5 or lasting more than 20 years in the implanted ear.
- Medical or psychological conditions contraindicating anesthesia or surgery.
- Skin conditions affecting wound healing.
- Unrealistic expectations about surgery or device.
- Additional disabilities affecting participation or safety.
- Unable or unwilling to comply with study requirements.
- Pregnant or breastfeeding women.
- Investigator site personnel and immediate family members.
- Employees of Cochlear or contractors involved in the study.
- Participation in another interventional clinical trial within the past 30 days (unless Cochlear-sponsored and not impacting this study).
Research Team
P
PRS Specialist
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