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Cochlear says it has completed recruitment for two pivotal studies of an investigational fully implantable cochlear implant system. Across the wider research program, 117 people have enrolled and participants have accumulated more than 1 million hours of experience with three generations of devices. The system is not approved for commercial distribution, and its safety and effectiveness have not been established.
Cochlear says it has completed recruitment for two worldwide pivotal studies of an investigational fully implantable cochlear implant system, with participants across its broader research program accumulating more than 1 million hours of experience with investigational devices. The milestone advances the company’s clinical evaluation, but the system remains unapproved for commercial distribution and its safety and effectiveness have not been established.
The pivotal program consists of the ELEVATE study, conducted at 11 sites in the United States, and the ENTERPRISE study, conducted at five sites in Europe and Australia. Together, the studies enrolled 92 adults: 56 in ELEVATE and 36 in ENTERPRISE. Cochlear said the total across those trials and three earlier feasibility studies is 117 people, with research spanning three generations of investigational devices since 2005.
The studies are designed to assess the system’s safety and effectiveness. A primary analysis is planned after six months, while participant follow-up will continue through 12 months. Cochlear said data collection will continue as it advances its development program toward regulatory submissions. The announcement did not report trial outcomes or establish how the investigational system performs compared with currently available implants.
Cochlear described four priorities guiding development: all-day hearing performance and battery longevity; internal dual microphones intended to address body noise; surgical simplicity and streamlined programming; and confidence supported by long-term clinical data and recipient feedback. These are development priorities, not reported findings that the system has already met them.
Evidence Before Wider Availability
Completing recruitment means the pivotal studies have enrolled their planned participants and can continue toward the scheduled analyses. The six-month primary analysis and follow-up through 12 months are expected to provide clinical data on safety, performance and recipient outcomes. That evidence will be relevant to any later regulatory review and to decisions about whether the technology can be offered to patients.
The reported 1 million hours of device experience reflects experience accumulated across the research program, which includes three generations of investigational devices. It is not itself a measure of effectiveness, nor does the announcement specify how those hours were distributed among participants or device generations. The trial data and regulatory process remain central to determining whether the system is suitable for clinical use.
For people considering hearing treatment, the current status matters: this technology is still investigational. ELEVATE coordinating investigator Craig Buchman said people who could benefit from a cochlear implant today should not delay current treatment while waiting for a possible future device. His comment distinguishes ongoing research from the established options available now.
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A Research Program Since 2005
Cochlear said the wider program began with feasibility studies in 2005 and has since evaluated three generations of investigational devices. The current pivotal phase brings together sites in the United States, Europe and Australia. Its recruitment milestone follows years of development and clinical research; the announcement does not say when regulatory submissions will be filed or when a decision might be made.
The company’s currently marketed cochlear implant technology remains distinct from the fully implantable system under study. Cochlear identifies its latest commercially available implant as the Nucleus Nexa System. The investigational system is not cleared for commercial distribution. Regulatory evaluation is required before it could become commercially available.
“We now have more than 20 years of experience across three generations of investigational devices.”
— Dig Howitt, Cochlear CEO and president
Trial Results Remain Pending
The announcement provides no results from either pivotal study. It remains unclear how participants’ outcomes compare with study goals, what adverse events or limitations may have been observed, and whether the system will satisfy regulatory requirements. The company has not provided a date for submission or a potential commercial launch.
The reported 1 million hours is an aggregate across the full program. The source does not give a breakdown by study, participant, or device generation, or define the calculation behind the total. The figure should be read as reported accumulated experience, not as evidence on its own that the device is safe or effective.
Follow-Up and Regulatory Review
Participants in ELEVATE and ENTERPRISE are expected to continue follow-up through 12 months, with primary safety and effectiveness analyses planned at six months. Cochlear says it will continue collecting data as it advances development toward regulatory submissions. The company has not announced a submission timetable, and any possible commercial availability depends on regulatory evaluation.
Until then, the system remains investigational. Buchman said patients who may benefit from an implant should speak with a qualified hearing care professional about currently available options rather than wait for this research program to conclude.
Key Questions
What did Cochlear announce?
Cochlear said it completed recruitment for the ELEVATE and ENTERPRISE pivotal studies of an investigational fully implantable cochlear implant system.
How many people have taken part in the research program?
The two pivotal studies enrolled 92 adults combined. Including three earlier feasibility studies, Cochlear reports 117 participants across the program since 2005.
Is the fully implantable system available to patients?
No. The system is investigational and is not approved for commercial distribution. Its safety and effectiveness have not been established.
What happens after recruitment?
Follow-up and data collection continue. The studies plan a primary safety and effectiveness analysis at six months and follow-up through 12 months; Cochlear says it is advancing development toward regulatory submissions.
Should someone wait for this system before considering an implant?
Buchman, an investigator in the program, said people who could benefit from a cochlear implant today should not wait for a future fully implantable device. Patients can discuss current treatment options with a qualified hearing care professional.
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