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Cochlear has completed worldwide recruitment for pivotal trials of its fully implantable cochlear implant system, with 92 adults enrolled across the ELEVATE and ENTERPRISE studies. Patients across the broader research program, running since 2005, have accumulated more than 1 million hours of experience with investigational devices. The device is not yet approved, and primary safety and effectiveness analyses are planned at six months with follow-up to 12 months.
Cochlear has completed worldwide recruitment for the pivotal trial program of its fully implantable cochlear implant system, with patients across the research effort having accumulated more than 1 million hours of experience with the investigational devices. The program’s two pivotal studies — ELEVATE at 11 US sites and ENTERPRISE at five sites in Europe and Australia — have enrolled a combined 92 adults, according to an announcement reported by The Hearing Review. The milestone moves the company closer to regulatory submissions for a device that is not yet approved for commercial distribution.
The announcement covers two pivotal trials. The ELEVATE study, conducted across 11 sites in the United States, is designed to evaluate the investigational system in 56 adults. The ENTERPRISE study, conducted across five sites in Europe and Australia, is designed to evaluate it in 36 adults. A primary analysis of safety and effectiveness is planned at six months, with follow-up continuing to 12 months.
Beyond the pivotal trials, the full research program includes three earlier feasibility studies dating back to 2005. In total, 117 patients have been enrolled across the program, spanning three generations of investigational devices. Cochlear said ongoing follow-up and data collection will continue as the company advances the development program toward regulatory submissions.
Cochlear outlined four development priorities it says have been shaped by lessons from the three device generations: all-day hearing performance in everyday environments and implant battery longevity; internal dual-microphone technology designed for body noise cancellation, surgical simplicity and streamlined programming; a familiar surgical technique intended to minimize additional theatre and anesthesia time; and confidence grounded in long-term clinical data, recipient insights and a large evidence base.
Why the Milestone Matters for Hearing Technology
A fully implantable cochlear implant would differ from current systems in that no external processor would be worn on the ear or head, which investigators suggest could affect daily convenience and quality of life. Prof Christophe Vincent, head of otology and otoneurology at Lille University Hospital and an ENTERPRISE investigator, said the study “will show how fully implantable hearing technology performs in everyday life and its potential to give people greater freedom and choice in how they hear throughout the day.”
The 1 million-hour figure, drawn from more than two decades of cumulative patient experience, represents the scale of evidence Cochlear intends to use in support of future regulatory submissions. For people with severe-to-profound hearing loss, the outcome of these trials could eventually expand the range of available treatment options — though any benefit remains unproven until the pivotal data are analyzed and reviewed by regulators.
Clinicians involved in the program were careful to stress that the investigational technology does not replace current care. Current cochlear implants remain the proven standard, and experts advised that eligible patients should not delay treatment in anticipation of fully implantable devices.
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Two Decades of Fully Implantable Device Research
Cochlear’s fully implantable research program began with feasibility studies in 2005, and the three earlier studies plus the two current pivotal trials cover three generations of investigational devices. The company’s latest commercially available cochlear implant is the Cochlear Nucleus Nexa System, which remains distinct from the investigational fully implantable system.
According to The Hearing Review, the field of fully implantable cochlear implant technology has been evolving steadily, with ongoing research advances and prior FDA activity around fully implanted systems. Cochlear’s pivotal program is one of the largest coordinated efforts in this area by enrollment and cumulative device experience, according to figures provided by the company.
“We are excited by the progress being made and remain focused on delivering technology that is safe, grounded in science and clinical evidence, and shaped by the needs of people living with hearing loss.”
— Dig Howitt, CEO and President of Cochlear
What the Trial Data Has Not Yet Shown
The investigational fully implantable system is not approved for commercial distribution, and Cochlear states that its safety and effectiveness have not yet been established. The primary analysis is not planned until the six-month timepoint, with follow-up extending to 12 months, so no pivotal results have been released.
The company has not publicly stated a timeline for regulatory submissions, nor which regulators it will approach first. Details such as the device’s battery life, charging approach, and how its everyday performance compares with conventional external-processor systems will depend on data that has not yet been published. It is also not clear when, or whether, the technology will become commercially available.
From Follow-Up Visits to Regulatory Filings
Enrolled patients in ELEVATE and ENTERPRISE will continue through scheduled follow-up, with the primary safety and effectiveness analysis planned at six months and continued observation to 12 months. Cochlear said data collection will support its advancement toward regulatory submissions, after which regulators would review the evidence before any commercial approval decision. Prospective patients interested in current treatment can consult qualified hearing health professionals about approved cochlear implant systems such as the Cochlear Nucleus Nexa System.
Key Questions
Is Cochlear’s fully implantable cochlear implant available yet?
No. The device is investigational, is not approved for commercial distribution, and its safety and effectiveness have not yet been established, according to Cochlear. Regulatory evaluation is required before it could become commercially available.
What do the 1 million hours refer to?
The figure represents cumulative patient experience with investigational fully implantable devices across Cochlear’s full research program, which dates back to 2005 and includes 117 enrolled patients across three device generations.
Should someone with hearing loss wait for a fully implantable implant?
Investigators involved in the trials say no. Prof Craig Buchman said current cochlear implant technology is proven and can provide meaningful access to sound now, and that eligible patients should not wait for future devices. Anyone considering treatment should consult a qualified hearing health professional.
What are the ELEVATE and ENTERPRISE studies measuring?
ELEVATE (11 US sites, 56 adults) and ENTERPRISE (five sites in Europe and Australia, 36 adults) are pivotal trials evaluating the investigational system’s safety and effectiveness, with a primary analysis at six months and follow-up to 12 months.
When will results be released?
No release date has been announced. The primary analysis is planned at the six-month timepoint after implantation, and Cochlear has not specified when regulatory submissions will be made.
Source: rss
