A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults (ELEVATE)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss, Bilateral Sensorineural
• Intervention / Treatment: Device: Cochlear implant

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PRS Specialist; Phone Number: +61294286555; Email: cltd-prs-admin@cochlear.com

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • Rocky Mountain Ear Center
      • Principal Investigator: David Kelsall
  • Florida
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami School of Medicine
      • Principal Investigator: Sandra Prentiss
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
      • University of Iowa
      • Principal Investigator: Bruce Gantz
  • Michigan
    • Novi, Michigan, United States, 48374
      • Not yet recruiting
      • Michigan Ear Institute
      • Principal Investigator: Robert Hong
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Not yet recruiting
      • Mayo Foundation Rochester
      • Principal Investigator: Matthew Carlson
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Midwest Ear Institute
      • Principal Investigator: Robert Cullen
      • Contact: Email: mei@saint-lukes.org
    • St Louis, Missouri, United States, 63108
      • Recruiting
      • Washington University School of Medicine
      • Principal Investigator: Jacques Herzog
  • New York
    • New York, New York, United States, 10017
      • Not yet recruiting
      • NYU Langone Health
      • Principal Investigator: J. Thomas Roland Jr.
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Not yet recruiting
      • University Hospitals Cleveland Medical Centre
      • Principal Investigator: Alejandro Rivas
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Recruiting
      • Hearts for Hearing Foundation
      • Principal Investigator: Rene Gifford
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Not yet recruiting
      • University of Utah Hospitals and Clinics
      • Principal Investigator: Richard Gurgel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Totally Implantable Cochlear Implant System; Participants will be implanted with the TI1132 implant	Device: Cochlear implant; Totally Implantable Cochlear Implant System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech recognition performance in quiet	Percent correct scores in word recognition score from pre-implantation to post-implantation.	Preimplantation to 6-months post-activation
Incidence of adverse events and device deficiencies	Frequency and severity of device and procedure-related adverse events, including device deficiencies.	Implantation to 6- and 12-months post-activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech, Spatial and Qualities of Hearing questionnaire (SSQ-12)	Speech, Spatial, and Qualities of Hearing Scale global score (SSQ-12). Scores range from 0 to 10, where higher scores indicate greater ability (less hearing disability).	Preimplantation to 6- and 12-months post-activation
Speech recognition performance in noise	Percent correct sentence score from preimplantation to 6- and 12-months post-activation.	Preimplantation to 6- and 12-months post-activation
Speech recognition performance in quiet	Percent correct word recognition score in quiet from pre-implantation to post-implantation.	Preimplantation to 12-months post-activation
Cochlear Implant Quality of Life Profile (CIQOL-35)	Cochlear implant hearing related quality of life score (CIQOL-35). Scored for six health domains (communication, emotional, entertainment, environment, listening effort, and social) each scaled from 0 to 100, where a higher score indicates better health.	Preimplantation to 6- and 12-months post-activation
Health Utilities Index (HUI 2/3)	Health Utilities Index (HUI 2/3) global score. Scores range from -0.36 to 1.00, where a negative score represents a state "worse than dead" and a top score of 1.00 is "perfect health".	Preimplantation to 6- and 12-months post-activation
Living with Cochlear Implants Questionnaire (LivCI)	Living with Cochlear Implants Questionnaire (LivCI) evaluates the impact of a hearing device on four domains, Participation (range 0 to 12), Psychosocial & Wellbeing (range 0 to 21), Stigma (range 0 to 15) and Management & Aesthetics (range 0 to 18), where a higher domain score indicates positive patient report.	Preimplantation to 6- and 12-months post-activation
Patient Satisfaction Survey	Device satisfaction rating score. Scores range from 1 to 5, where a higher score indicates greater patient satisfaction with the TICI system.	From 6 to 12 months post-activation

Collaborators and Investigators

• Sponsor: Cochlear
• Investigators: Principal Investigator: Craig Buchman, University of Utah

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss; Equipment and Supplies; Electrodes; Electrical Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants; Neural Prostheses; Implantable Neurostimulators; Hearing Aids; Sensory Aids; Cochlear Implants
• Other Study ID Numbers: CLTD5828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes