Actively Recruiting
A Pivotal Study to Evaluate Clinical Benefit, Performance, and Safety of the TI1132 Totally Implantable Cochlear Implant System in Adults With Sensorineural Hearing Loss
Led by Cochlear · Updated on 2026-05-22
56
Participants Needed
11
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical benefit, performance, and safety of a new totally implantable cochlear implant (TICI) system in adults with bilateral sensorineural hearing loss. This type of hearing loss results from damage to the inner ear or auditory nerve, affecting the ability to hear sounds and speech. The study is pivotal and prospective, focusing on adults with this condition to better understand how the implant may improve hearing without visible external parts. Participants will receive the TI1132 implant, which includes a microphone placed under the skin to detect environmental sounds and speech. The implant is fully contained beneath the skin, offering an option to hear without any external devices. The study involves implantation of the device and follows participants through a series of timepoints after activation to assess performance and safety. During the study, participants will undergo hearing tests, including speech recognition in quiet and noise, and complete questionnaires about their hearing experience and quality of life. Researchers will monitor adverse events and device issues from implantation up to 12 months post-activation. The study collects patient satisfaction data and health-related quality of life measures, with follow-ups extending to one year after activation to evaluate long-term outcomes.
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 or greater in the ear to be implanted
- Functional hearing in the aided condition of 40% correct or less on a word recognition test in the ear to be implanted
- Sensorineural hearing loss with a pure-tone average threshold of 30 dB or greater in the contralateral ear
- Fluent speaker in the language used for speech 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 implantation during the study period
- Single-sided deafness
- Inner brain lesions or acoustic nerve damage affecting the ear to be implanted
- Middle ear infection at or within 3 months prior to surgery
- Tympanic membrane perforation or recent ear surgery within 3 months
- Auditory neuropathy diagnosis in the ear to be implanted
- Cochlear abnormalities preventing full electrode insertion
- Current cerebrospinal fluid shunts, fistulas, skull fractures, or leaks
- Severe bilateral hearing loss before age 5
- Hearing loss in the implanted ear for more than 20 years
- Medical or psychological conditions contraindicating surgery or study participation
- Pre-existing skin conditions that affect wound healing
- Unrealistic expectations regarding surgery or device
- Additional disabilities affecting participation or safety
- Unable or unwilling to comply with study requirements
- Pregnant or breastfeeding women
- Study personnel or immediate family related to the investigator or sponsor
- Participation in another investigational study within past 30 days (with exceptions)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and following days as needed
Participants undergo implantation with the totally implantable cochlear implant system and receive immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Up to 12 months post-activation
Participants are followed after surgery to monitor recovery, device performance, and safety.
Multiple visits up to 12 months post-activation
Trial Site Locations
Total: 11 locations
1
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
Actively Recruiting
2
University of Miami School of Medicine
Miami, Florida, United States, 33136
Not Yet Recruiting
3
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
4
Michigan Ear Institute
Novi, Michigan, United States, 48374
Not Yet Recruiting
5
Mayo Foundation Rochester
Rochester, Minnesota, United States, 55902
Not Yet Recruiting
6
Midwest Ear Institute
Kansas City, Missouri, United States, 64111
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63108
Actively Recruiting
8
NYU Langone Health
New York, New York, United States, 10017
Not Yet Recruiting
9
University Hospitals Cleveland Medical Centre
Beachwood, Ohio, United States, 44122
Not Yet Recruiting
10
Hearts for Hearing Foundation
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
11
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
Research Team
P
PRS Specialist
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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