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Cochlear has completed recruitment for two pivotal studies of an investigational fully implantable cochlear implant system. Across its research program, 117 people have enrolled since 2005, and participants have accumulated more than 1 million hours of experience with investigational devices.
Cochlear has completed recruitment for two pivotal studies of its investigational fully implantable cochlear implant system, reporting that participants across its research program have logged more than 1 million hours with investigational devices. The milestone advances clinical evaluation, but the system is not approved for commercial distribution, and its safety and effectiveness have not been established.
The pivotal program comprises ELEVATE, conducted at 11 sites in the United States, and ENTERPRISE, conducted at five sites in Europe and Australia. Together, the studies enrolled 92 adults: ELEVATE was designed for 56 participants and ENTERPRISE for 36. Cochlear said the milestone covers experience with the investigational devices; the announcement does not specify how the total hours are divided among participants or device generations.
Including three earlier feasibility studies that began in 2005, the full program has enrolled 117 people across three generations of investigational devices. Cochlear plans a primary analysis of safety and effectiveness at six months for the pivotal studies, with participant follow-up continuing to 12 months. The company said data collection will continue as it advances development toward regulatory submissions.
The company listed four priorities for development: all-day hearing performance and battery longevity; internal dual microphones intended to address body noise; a familiar surgical technique; and confidence built through long-term clinical data and recipient feedback. These are development priorities, not findings that the system has already met those goals.
Evidence Before Wider Availability
Completing recruitment allows the pivotal studies to move into continued follow-up and analysis, which can help build the clinical evidence needed for regulatory review. The reported million hours of experience signals the scale of exposure across the broader research effort, but hours alone do not establish safety, effectiveness, or a benefit over currently available implants.
For people considering cochlear implants, the distinction matters: this system remains investigational, while existing cochlear implant technology is available now. ELEVATE coordinating investigator Craig Buchman said people who could benefit from a cochlear implant today should not wait for future fully implantable devices. He described current technology as proven and said it can provide access to sound and support communication and quality of life.
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Research Spanning Three Generations
Cochlear said the fully implantable effort dates to 2005 and includes three feasibility studies before the current pivotal program. The 117 participants across the overall program have used three generations of investigational devices, according to the company. The latest pivotal studies are intended to gather safety, performance, and recipient outcome evidence in adults.
The company says lessons from the program have shaped its priorities, including day-long performance, battery life, microphone design, surgical demands, and evidence from longer-term follow-up. Its latest commercially available cochlear implant is the Nucleus Nexa System, according to the source report. The fully implantable device described in the studies is a separate investigational system.
“We now have more than 20 years of experience across three generations of investigational devices.”
— Dig Howitt, Cochlear CEO and president
Safety and Performance Still Under Study
The announcement does not report the pivotal studies’ results. Safety and effectiveness have not been established, and the system has not received approval for commercial distribution. Cochlear has not provided a regulatory decision date or a timeline for potential commercial availability in the source material.
The reported hour total is across the research program; the announcement does not break it down by study, individual participant, or device generation. It also does not provide outcome data on hearing performance, battery longevity, or how the system compares with commercially available implants.
Follow-Up and Regulatory Review
Participants in ELEVATE and ENTERPRISE are expected to continue follow-up through 12 months, after the planned six-month primary analysis of safety and effectiveness. Cochlear said it will continue collecting data and move the development program toward regulatory submissions.
Any commercial availability would depend on regulatory evaluation. Until then, the system remains investigational, and the study results and review timeline remain outstanding.
Key Questions
What did Cochlear announce?
Cochlear said recruitment is complete for ELEVATE and ENTERPRISE, two pivotal studies of its investigational fully implantable cochlear implant system.
How many people have enrolled?
The two pivotal studies enrolled 92 adults. Including three earlier feasibility studies, Cochlear reports 117 participants across the full program since 2005.
Is the fully implantable system available now?
No. The system is investigational and not approved for commercial distribution. Its safety and effectiveness have not been established.
What happens after recruitment?
Follow-up and data collection continue. Cochlear plans a primary safety and effectiveness analysis at six months, with study follow-up continuing to 12 months.
Should patients wait for this technology?
ELEVATE investigator Craig Buchman said people who could benefit from a cochlear implant today should not wait for future devices. The investigational system has not replaced currently available cochlear implant options.
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