Loading clinical trials...

RECRUITINGNA

A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss

A Feasibility, Interventional, Prospective Study to Enhance Features and Optimise the Clinical Pathway for the TICI Research System in Adult Cochlear Implant Recipients

NCT06642935•Cochlear

View on ClinicalTrials.gov

Summary

This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing hearing without the need of any external parts. This study will explore new ways to process the sound from the implanted microphone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 years or older, at time of consent
•Candidate for cochlear implantation as assessed by the implanting clinic
•Fluent in English, as determined by the investigator
•Willing to participate in and comply with all requirements of the protocol
•Willing and able to provide written informed consent

Exclusion Criteria

•Severe, or poorer, bilateral sensorineural hearing loss prior to five years of age, as reported by the subject
•Duration of severe to profound hearing loss greater than 20 years in the ear to be implanted as reported by the subject or by audiometric history, if available
•Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array
•Deafness due to lesions of the acoustic nerve affecting the ear to be implanted
•Medical or psychological conditions that would contraindicate undergoing anaesthesia, surgery or participation in the clinical investigation, as determined by the investigator
•Additional disabilities that may affect the subject's participation or safety during the clinical investigation, as determined by the investigator
•Unrealistic expectations on the part of the subject regarding the possible benefits, risks and limitations that are inherent to the surgical procedure and prosthetic device, as determined by the investigator
•Desire to use an integrated acoustic component post-implantation
•Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
•Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
+2 more criteria

Locations (1)

Royal Victoria Eye and Ear Hospital

Melbourne, Victoria, Australia

Key Dates

Start Date

November 18, 2024

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2027

Last Updated

November 24, 2025

Enrollment

ESTIMATED participants

Conditions

Hearing Loss, Bilateral or UnilateralHearing Loss, SensorineuralHearing Loss, Cochlear

Interventions

Totally implantable cochlear Implant

DEVICE

Contacts

Niva Shrestha Clinical Project Manager

CONTACT

+61 2 9428 6555 nshrestha@cochlear.com

Preschool Hearing Screening

NCT06058767

Hearing LossHearing Disorders in Children+6 more

View study

RECRUITINGNA

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

NCT06641999

TinnitusHearing Loss, Bilateral or Unilateral+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss

Inclusion Criteria

Exclusion Criteria

Preschool Hearing Screening

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL

Clinical Trial to Compare Two Surgical Approaches to the Cochlea

Post-Market Clinical Investigation of the IotaSOFT Insertion System