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

Launched by COCHLEAR · Oct 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of cochlear implant system called TICI G2, which is designed to help adults with severe hearing loss hear better. Unlike traditional cochlear implants that have external parts, this device has an implantable microphone that is placed under the skin. This allows it to pick up sounds and speech from the environment without needing any outside equipment. The researchers want to find out how to make the sound processing from this microphone even better.

To participate in this study, individuals need to be at least 18 years old and assessed as a good candidate for cochlear implantation by a medical clinic. They should also be fluent in English and willing to follow the study's requirements. Participants will undergo several tests to check their hearing and how well the implant works, and they will fill out questionnaires about their hearing experiences and overall health. This study is currently recruiting participants, and it offers an opportunity to help advance hearing technology for those with significant hearing challenges.

Gender

ALL

Eligibility criteria

• 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
• • Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this 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)