From left, Melbourne ENT surgeon Professor Robert Briggs, and Cochlear’s CEO and president Dig Howitt. Images: The Royal Victorian Eye and Ear Hospital, and Hearing Australia. Cochlear has completed recruitment for its worldwide pivotal trial program evaluating its fully implantable hearing technology, also referred to as a totally implantable cochlear implant (TICI)....
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✦ The floor
Discussion
Signed responses from readers of the wire.
No actionable clinical change yet — trial recruitment completion is a pipeline milestone; audiologists should monitor publication of efficacy and safety outcomes before considering referral pathways for fully implantable devices.
Completion of global pivotal trial recruitment for a fully implantable hearing device marks a significant regulatory step toward a potential new category of implantable solution for patients who prefer no external hardware.
- 01Cochlear has completed worldwide recruitment for its pivotal trial of a fully implantable hearing device.
- 02Trial participants have accumulated over one million hours of real-world device experience.
- 03A fully implantable device would have no external components, unlike current cochlear implants.
- 04Pivotal trial completion is a prerequisite step toward regulatory submission and approval.
- 05No efficacy or safety outcome data are yet publicly reported from the trial.
Cochlear has surpassed one million hours of patient experience in its fully implantable hearing device pivotal trials.
press releasepartially supportedCochlear has completed global recruitment for its pivotal trial program for a fully implantable hearing device.
press releasesupported