Actively Recruiting
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Led by Cochlear · Updated on 2026-05-06
56
Participants Needed
11
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts. This study will involve 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). Participants will complete hearing tests and questionnaires to evaluate how well the system works and how it affects their daily life.
CONDITIONS
Official 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 an average hearing threshold of 70 dB HL or worse in the ear to be implanted.
- Functional hearing in the aided condition with 40% correct or less on a word recognition test in the ear to be implanted.
- Sensorineural hearing loss with an average hearing threshold of 30 dB HL or worse 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 during the study.
- Single-sided deafness.
- Brain lesions or acoustic nerve lesions affecting the ear to be implanted.
- Middle ear infection or ear surgery within 3 months prior to enrollment in the ear to be implanted.
- Presence of a tympanic membrane perforation or history of recent otologic surgery in the ear to be implanted.
- Diagnosis of auditory neuropathy in the ear to be implanted.
- Cochlear malformations or anomalies preventing electrode insertion.
- Current cerebrospinal fluid shunts, leaks, skull fractures, or perilymph fistula.
- Severe bilateral sensorineural hearing loss before age 5.
- Sensorineural hearing loss lasting more than 20 years in the ear to be implanted.
- Medical or psychological conditions contraindicating surgery or study participation.
- Pre-existing skin conditions that may affect wound healing.
- Unrealistic expectations regarding benefits, risks, and limitations of the device and surgery.
- Additional disabilities affecting participation or safety.
- Unable or unwilling to comply with study requirements.
- Pregnant or breastfeeding women.
- Investigator site personnel, immediate family, Cochlear employees, or contractors involved in the study.
- Current or recent participation in other interventional clinical studies within 30 days, unless Cochlear-sponsored and approved.
AI-Screening
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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
Not Yet Recruiting
11
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
Research Team
P
PRS Specialist
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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