Cochlear Completes Enrollment in Implant Trials
The company has enrolled 92 patients in two pivotal studies of its fully implantable hearing technology.
Updated on Nov. 3, 2026 in Stroke
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Cochlear has completed patient enrollment in its ELEVATE and ENTERPRISE pivotal studies of fully implantable hearing technology, with 92 patients across both trials. The company plans a primary analysis of safety and effectiveness at six months, with follow-up continuing to 12 months.
Why it matters
Fully implantable hearing technology would integrate the microphone, sound processing chip and battery beneath the skin, potentially removing the need for an externally worn processor during everyday use. The results of these pivotal studies will determine whether the technology moves toward commercial availability.
The figures come from Cochlear's enrollment counts across its pivotal and feasibility studies, with 92 patients in the two pivotal trials and 117 enrolled since 2005. Safety and effectiveness results remain unreported, with the primary analysis planned for six months after enrollment completion.
The players
Cochlear
Cochlear is an Australian hearing implant company headquartered in Sydney that has developed cochlear implant systems for decades.
The details
Cochlear, headquartered in Sydney, Australia, recruited 56 adults at 11 U.S. sites for the ELEVATE study and 36 adults at five sites in Australia and France for the ENTERPRISE study. The investigational TICI system places its dual internal microphone, sound processing chip and rechargeable battery beneath the skin, with external charging.
Timeline
2005: Cochlear's feasibility studies of implantable hearing technology began.
Six months after enrollment completion: planned primary analysis of safety and effectiveness.
12 months after enrollment completion: planned end of follow-up for longer-term data.
Health Landscape
Cochlear's investigational TICI system is positioned as an extension of its commercially available Nucleus Nexa System rather than a replacement for it. The company does not expect fully implantable technology to replace traditional cochlear implants.
For people with hearing loss, a fully implantable system could eliminate the need to wear an external sound processor during everyday activities. Whether this becomes an option will depend on the safety and effectiveness results from the six-month analysis.
The takeaway
Fully implantable hearing technology is still in the trial stage, and the six-month safety and effectiveness results will be the next key indicator of whether it advances. Readers with hearing loss should continue to rely on current treatment options while the research develops.
Further reading
Explore more Stroke coverage for context on how implantable and neurological health technologies are being developed.
Source note: This article includes information reported by MDDI Online.
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