A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
NCT ID: NCT07287124
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2026-04-30
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Totally Implantable Cochlear Implant System
Participants will be implanted with the TI1132 implant
Cochlear implant
Totally Implantable Cochlear Implant System
Interventions
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Cochlear implant
Totally Implantable Cochlear Implant System
Eligibility Criteria
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Inclusion Criteria
* Clinically established sensorineural hearing loss (SNHL) defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥70 dB HL in the ear to be implanted.
* Compromised functional hearing in the aided condition defined as ≤40% correct on a word recognition test in the ear to be implanted.
* Clinically established SNHL defined by a four-frequency (500, 1000, 2000 \& 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the contralateral ear.
* Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
* Direct access to a compatible Smart Phone.
* Willing and able to provide written informed consent.
Exclusion Criteria
* Candidates with single-sided deafness as determined by the investigator.
* Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
* Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
* Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
* Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.
* Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.
* Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.
* Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the participant.
* Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported by the participant, in the ear to be implanted.
* Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the investigator.
* Pre-existing skin condition that could jeopardize wound healing as judged by the investigator e.g., psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.
* Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.
* Additional disabilities that may affect the participant's participation or safety during the clinical investigation.
* Unable or unwilling to comply with all requirements of the clinical investigation, as determined by the investigator.
* Pregnant or breastfeeding women.
* Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of the investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
18 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Buchman
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Rocky Mountain Ear Center
Englewood, Colorado, United States
University of Miami School of Medicine
Miami, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Michigan Ear Institute
Novi, Michigan, United States
Mayo Foundation Rochester
Rochester, Minnesota, United States
Midwest Ear Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
New York University
New York, New York, United States
University Hospitals Cleveland Medical Centre
Beachwood, Ohio, United States
Hearts for Hearing Foundation
Oklahoma City, Oklahoma, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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CLTD5828
Identifier Type: -
Identifier Source: org_study_id