TL;DR
Turn quiet afternoons into listening time
- Thousands of audiobooks, podcasts and originals
- Listen on your phone, tablet or Echo — also offline
- Cancel anytime
Cochlear has completed recruitment for worldwide pivotal trials of a fully implantable cochlear implant system, with 117 patients enrolled since 2005 and more than 1 million hours of cumulative patient experience. Safety and effectiveness are not yet established, and regulatory approval is still required.
Cochlear has completed worldwide recruitment for the pivotal trials of its fully implantable cochlear implant system, with patients across the research program having accumulated more than 1 million hours of experience with the investigational devices, the company announced. The milestone covers the ELEVATE study at 11 US sites and the ENTERPRISE study at five sites in Europe and Australia, enrolling a combined 92 adults in a research program that dates back to 2005.
The announcement encompasses two pivotal studies: ELEVATE, designed to evaluate the investigational system in 56 adults across 11 sites in the United States, and ENTERPRISE, designed to evaluate it in 36 adults across five sites in Europe and Australia. Together they have enrolled 92 adults. Including three earlier feasibility studies, 117 patients have been enrolled across the full research program, which spans three generations of investigational devices.
According to Cochlear, a primary analysis of safety and effectiveness is planned at six months, with follow-up continuing to 12 months. The company said ongoing follow-up and data collection will continue as it advances the development program toward regulatory submissions.
Cochlear outlined four development priorities drawn from lessons across the three device generations: all-day hearing performance and implant battery longevity; internal dual-microphone technology designed for body noise cancellation, surgical simplicity and streamlined programming; a surgical technique familiar enough to minimize additional theatre and anesthesia time; and confidence grounded in long-term clinical data and recipient insights.
Why a Fully Implantable Implant Matters
Current cochlear implants rely on externally worn sound processors, which users must remove for sleeping, swimming and other activities. A fully implantable system, if proven safe and effective, could allow continuous hearing throughout the day without external hardware — a change investigators frame in quality-of-life terms. Prof Christophe Vincent, an ENTERPRISE investigator at Lille University Hospital, 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 reflects cumulative patient experience across two decades of investigation, which Cochlear says has shaped its understanding of what recipients and clinicians need. The pivotal data will form the basis for regulatory evaluation, a required step before the technology can become commercially available.
Clinical experts stressed that the investigational status should not delay treatment: “Current cochlear implant technology is proven and can provide meaningful access to sound, improvements in communication and quality of life now,” said Prof Craig Buchman, coordinating investigator of ELEVATE.
Two Decades of Fully Implantable Research
Cochlear’s fully implantable research program began with feasibility studies in 2005, three of which preceded the current pivotal trials. Over that period, the program has tested three generations of investigational devices. CEO and president Dig Howitt said the accumulated experience has given the company “a strong understanding of what recipients and clinicians need in everyday life.”
Cochlear’s latest commercially available implant is the Nucleus Nexa System. The investigational fully implantable system is not approved for commercial distribution, and its safety and effectiveness have not yet been established. The Hearing Review has previously reported on broader industry research into fully implanted cochlear systems and related FDA activity.
“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, Cochlear
What the Trial Results Have Not Shown Yet
The safety and effectiveness of the fully implantable system have not yet been established, and the device is not approved for commercial distribution anywhere. The six-month primary analysis has not been reported; results, timing of regulatory submissions, and which markets the company will target first all remain unclear. Cochlear has not publicly detailed device specifications such as expected battery life per charge or recharge intervals, nor when recruitment-completed sites expect to publish interim findings.
From Follow-Up Data to Regulatory Review
Enrolled patients will continue in follow-up through 12 months, with the primary safety and effectiveness analysis planned at the six-month mark. Cochlear said data collection will support advancement of the development program toward regulatory submissions, after which agencies such as the FDA would review whether the system can be made commercially available. No submission timeline was disclosed.
Key Questions
What did Cochlear announce?
Completion of worldwide recruitment for the pivotal trials of its fully implantable cochlear implant system — the US-based ELEVATE study and the Europe/Australia ENTERPRISE study — plus the milestone of more than 1 million cumulative hours of patient experience across its research program since 2005.
Is the fully implantable cochlear implant available to patients?
No. The investigational system is not approved for commercial distribution, and its safety and effectiveness have not yet been established. Regulatory evaluation is required before it can be made commercially available.
How many patients are enrolled in the studies?
The two pivotal studies enrolled a combined 92 adults — 56 in ELEVATE and 36 in ENTERPRISE. Including three earlier feasibility studies since 2005, the full program has enrolled 117 patients across three generations of devices.
When will results be available?
A primary analysis of safety and effectiveness is planned at six months after implantation, with follow-up continuing to 12 months. Cochlear has not announced when results or regulatory submissions will occur.
Should people with hearing loss wait for this technology?
Investigators say no. Prof Craig Buchman said current cochlear implant technology “is proven” and can provide meaningful access to sound and quality-of-life benefits now, while fully implantable research continues. Anyone considering treatment should consult a qualified hearing health professional.
Source: rss
Fall Picks
fall essentials
As an affiliate, we earn on qualifying purchases.
