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

July 29, 2026 updated by: Cochlear

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami School of Medicine
        • Principal Investigator:
          • Sandra Prentiss
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • Bruce Gantz
        • Contact:
    • Michigan
      • Novi, Michigan, United States, 48374
        • Recruiting
        • Michigan Ear Institute
        • Principal Investigator:
          • Robert Hong
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Foundation Rochester
        • Principal Investigator:
          • Matthew Carlson
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Midwest Ear Institute
        • Principal Investigator:
          • Robert Cullen
        • Contact:
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Jacques Herzog
        • Contact:
    • New York
      • New York, New York, United States, 10017
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • J. Thomas Roland Jr.
        • Contact:
    • Ohio
      • Beachwood, Ohio, United States, 44122
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Hospitals and Clinics
        • Principal Investigator:
          • Richard Gurgel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Speech recognition performance in quiet
Time Frame: Preimplantation to 6-months post-activation
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
Time Frame: Implantation to 6- and 12-months post-activation
Frequency and severity of device and procedure-related adverse events, including device deficiencies.
Implantation to 6- and 12-months post-activation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Speech, Spatial and Qualities of Hearing questionnaire (SSQ-12)
Time Frame: Preimplantation to 6- and 12-months post-activation
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
Time Frame: Preimplantation to 6- and 12-months post-activation
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
Time Frame: Preimplantation to 12-months post-activation
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)
Time Frame: Preimplantation to 6- and 12-months post-activation
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)
Time Frame: Preimplantation to 6- and 12-months post-activation
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)
Time Frame: Preimplantation to 6- and 12-months post-activation
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
Time Frame: From 6 to 12 months post-activation
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cochlear

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Craig Buchman, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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