Recruiting

TICI System

Sponsor:

Cochlear

Code:

NCT07287124

Conditions

Hearing Loss, Bilateral Sensorineural

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cochlear implant

Study Details

Brief summary:

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

Hearing Loss, Bilateral Sensorineural

Study ID

NCT07287124

Start date

Apr 3, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

56 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Totally Implantable Cochlear Implant System

Participants will be implanted with the TI1132 implant

Interventions

Cochlear implant

Totally Implantable Cochlear Implant System

Primary outcome measure

  • Speech recognition performance in quiet [ Time Frame: Preimplantation to 6-months post-activation ]
  • Incidence of adverse events and device deficiencies [ Time Frame: Implantation to 6- and 12-months post-activation ]

Central Contacts and Locations

Central contacts

PRS Specialist

+61294286555cltd-prs-admin@cochlear.com

Locations

Rocky Mountain Ear Center

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Megan Hollenback

meganh@rockymountaincenter.com

Principal Investigator:

David Kelsall

University of Miami School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Kristine Harris

keh129@med.miami.edu

Principal Investigator:

Sandra Prentiss

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Kesten Anderson

kesten-anderson@uiowa.edu

Principal Investigator:

Bruce Gantz

Michigan Ear Institute

Recruiting

Novi, Michigan, United States, 48374

Contacts

Sandra Porps, AuD

sporps@michiganear.com

Principal Investigator:

Robert Hong

Mayo Foundation Rochester

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Nicole Tombers

Tombers.Nicole@mayo.edu

Principal Investigator:

Matthew Carlson

Midwest Ear Institute

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

mei@saint-lukes.org

Principal Investigator:

Robert Cullen

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Susan Rathgeb

s.rathgeb@wustl.edu

Principal Investigator:

Jacques Herzog

NYU Langone Health

Recruiting

New York, New York, United States, 10017

Contacts

Ashley Feng

ashley.feng@nyulangone.org

Principal Investigator:

J. Thomas Roland Jr.

University Hospitals Cleveland Medical Centre

Recruiting

Beachwood, Ohio, United States, 44122

Contacts

Meghna Khare Nayate

Meghna.KhareNayate@UHhospitals.org

Principal Investigator:

Alejandro Rivas

Hearts for Hearing Foundation

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Ali Garriga

ali.garriga@heartsforhearing.org

Principal Investigator:

Rene Gifford

University of Utah Hospitals and Clinics

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Wilson Chen

u0661901@umail.utah.edu

Principal Investigator:

Richard Gurgel

More Information

Sponsor

Cochlear

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cochlear on 2026-07-31.