Totally implantable cochlear implant (TICI) system for adults with sensorineural hearing loss

A Pivotal, Pre-market, Prospective, Interventional, Multi-centre Study to Evaluate Clinical Benefit, Performance, and Safety of the TI1132 Implant in an Adult Population With Sensorineural Hearing Loss

This study will try a totally implantable cochlear implant with an under‑skin microphone to help adults with bilateral sensorineural hearing loss hear without visible external parts.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cochlear (Industry-sponsored)
• Locations: 11 sites (Englewood, Colorado and 10 other locations)
• Trial ID: NCT07287124 on ClinicalTrials.gov

What this trial studies

This multicenter interventional study implants a totally implantable cochlear implant (TICI) system that uses a subcutaneous microphone to pick up speech and environmental sounds. Eligible adults undergo surgery to receive the device and then complete standardized audiologic tests and patient‑reported questionnaires at scheduled follow‑ups to measure speech perception, device performance, and safety. Key entry criteria include an unaided four‑frequency PTA4 ≥70 dB HL in the ear to be implanted and ≤40% aided word recognition in that ear, while prior cochlear implantation is excluded. Study visits take place at selected U.S. centers and require smartphone compatibility for device features and follow‑up assessments.

Who should consider this trial

Good fit: Adults (18+) with bilateral sensorineural hearing loss who meet the study thresholds (unaided PTA4 ≥70 dB HL in the implanted ear and ≤40% aided word recognition) who are fluent in the test language and have access to a compatible smartphone.

Not a fit: People with prior cochlear implantation, primarily conductive or only mild-to-moderate hearing loss, or medical conditions that make surgery unsafe are unlikely to receive benefit from this device.

Why it matters

Potential benefit: If successful, the device could let adults with severe sensorineural hearing loss hear without visible external components, improving convenience and social comfort.

How similar studies have performed: Conventional cochlear implants are well established and effective, but fully implantable cochlear systems are relatively novel and have limited long‑term published data so far.

Eligibility criteria

Inclusion Criteria:

* Individuals aged 18 years and older at time of consent.
* 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:

* Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
* 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).

Where this trial is running

Englewood, Colorado and 10 other locations

• Rocky Mountain Ear Center — Englewood, Colorado, United States (Recruiting)
• University of Miami School of Medicine — Miami, Florida, United States (Not_yet_recruiting)
• University of Iowa — Iowa City, Iowa, United States (Not_yet_recruiting)
• Michigan Ear Institute — Novi, Michigan, United States (Not_yet_recruiting)
• Mayo Foundation Rochester — Rochester, Minnesota, United States (Not_yet_recruiting)
• Midwest Ear Institute — Kansas City, Missouri, United States (Recruiting)
• Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
• NYU Langone Health — New York, New York, United States (Not_yet_recruiting)
• University Hospitals Cleveland Medical Centre — Beachwood, Ohio, United States (Not_yet_recruiting)
• Hearts for Hearing Foundation — Oklahoma City, Oklahoma, United States (Not_yet_recruiting)
• University of Utah Hospitals and Clinics — Salt Lake City, Utah, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Craig Buchman — University of Utah
• Study coordinator: PRS Specialist

Conditions Hearing Loss, Bilateral Sensorineural