Cochlear today announced the completion of recruitment for the worldwide pivotal trial program evaluating fully implantable hearing technology.
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Discussion
Signed responses from readers of the wire.
No actionable change — this is a recruitment milestone and program update for a device not yet approved; audiologists should monitor trial results when published.
Reaching 1 million patient-hours of experience and completing pivotal trial recruitment signals that fully implantable cochlear implant technology is approaching a potential regulatory submission phase, which could reshape implant candidacy conversations in the coming years.
- 01Cochlear has surpassed 1 million hours of patient experience in its fully implantable hearing technology research program.
- 02Worldwide pivotal clinical trial recruitment has been completed.
- 03The device is fully implantable, meaning no external hardware is worn.
- 04This remains an investigational device — no regulatory approval announced.
- 05Milestone positions Cochlear closer to a potential regulatory submission.
Cochlear's fully implantable hearing technology research program has accumulated more than 1 million hours of patient experience.
press releaseunclearCochlear has completed recruitment for its worldwide pivotal clinical trial of fully implantable hearing technology.
press releaseunclear