NCT06642935

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss, Bilateral or Unilateral
• Hearing Loss, Sensorineural
• Hearing Loss, Cochlear

Interventions

Type	Name	Description
DEVICE	Totally implantable cochlear Implant	Totally implantable cochlear Implant

Timeline

• Start date: 2024-11-18
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2024-10-15
• Last updated: 2025-11-24

Locations

1 site across 1 country: Australia