Exploring a new totally implanted cochlear implant system for 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
This study is testing a new fully implanted cochlear implant system to see if it can help adults with severe hearing loss hear better without any external parts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06642935 on ClinicalTrials.gov |
What this trial studies
This clinical study tests a new investigational totally implanted cochlear implant system (TICI G2) designed for adults with sensorineural hearing loss. The implant features an internal microphone that detects speech and sound without external components. Participants will undergo various tests to evaluate the implant's performance and their hearing abilities, along with completing questionnaires about their hearing and overall health. The study aims to improve sound processing methods for better hearing outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are fluent in English and are suitable for cochlear implantation.
Not a fit: Patients with severe bilateral sensorineural hearing loss prior to age five or those with specific cochlear anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective hearing solution for adults with severe hearing loss.
How similar studies have performed: Other studies have shown promise with cochlear implants, but this specific approach with a totally implanted system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Melbourne, Victoria
- Royal Victoria Eye and Ear Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Niva Shrestha Clinical Project Manager
- Email: nshrestha@cochlear.com
- Phone: +61 2 9428 6555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.