Cochlear Completes Recruitment for Global Pivotal Program Evaluating Fully Implantable Hearing Technology
Cochlear has announced the completion of patient recruitment for its worldwide pivotal clinical trial program evaluating fully implantable hearing technology, marking a significant milestone in the company’s long-term development efforts in this emerging area of hearing care.
According to Cochlear, patients participating across its fully implantable hearing system research programs have accumulated more than 1 million hours of experience with their devices to date. The company said the milestone reflects the breadth and duration of its research into fully implantable hearing technology and builds on more than two decades of development experience.
The company’s global clinical research program is intended to generate evidence on the safety, performance and real-world experience associated with fully implantable hearing systems. Cochlear said the program represents its most comprehensive research effort to date focused on this category of hearing technology.
Recruitment has now been completed for the ELEVATE study, which is being conducted across 11 sites in the United States, as well as the ENTERPRISE study, which is being conducted across five sites in Europe and Australia. Together, the two pivotal studies include 92 patients whose follow-up and data collection will continue as Cochlear advances its development program toward regulatory submissions.
The latest milestone follows years of feasibility research. Including previous feasibility studies that began in 2005, more than 100 patients have received Cochlear fully implantable hearing technology, according to the company.
More Than 20 Years of Fully Implantable Technology Research
Fully implantable hearing technology represents a potential new direction for people who require hearing implants. Unlike conventional externally worn components, a fully implantable system is designed to place the key components of the hearing system beneath the skin, with the goal of providing hearing support without the need for external hardware during everyday use.
Cochlear’s research into the technology has extended across three generations of investigational devices. The company said the experience accumulated through these generations has helped its teams understand the technical, clinical and practical considerations that are important to both recipients and healthcare professionals.
“Fully implantable technology represents an exciting future direction for hearing care. We now have more than 20 years of experience across three generations of investigational devices. This has given us a strong understanding of what recipients and clinicians need in everyday life. We’re committed to delivering meaningful real-world benefits for recipients,” said Dig Howitt, Cochlear’s chief executive officer and president.
The company said the development program has been shaped not only by technical considerations but also by insights into how hearing implant recipients use their devices in everyday environments.
As recruitment moves into the follow-up stage, Cochlear will continue collecting clinical data from participants to build the evidence base required to support its future regulatory activities.
ELEVATE and ENTERPRISE Studies Reach Recruitment Milestone
The completion of recruitment in ELEVATE and ENTERPRISE represents an important stage in Cochlear’s global pivotal trial program.
The ELEVATE study has completed recruitment across 11 sites in the United States. Professor Craig Buchman, MD, FACS, professor of otolaryngology-head and neck surgery at University of Utah Health and coordinating investigator of ELEVATE, described the study as an important step in establishing clinical evidence around fully implantable hearing technology.
“This pivotal program is building a robust evidence base on safety, performance and recipient outcomes – critical to advancing fully implantable hearing technology with clinical confidence,” Professor Buchman said.
The ENTERPRISE study, meanwhile, has completed recruitment across five sites in Europe and Australia. Professor Christophe Vincent, head of otology and otoneurology at Lille University Hospital and an investigator in the ENTERPRISE study, said the study will provide information about how fully implantable technology performs in everyday settings.
“ENTERPRISE 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,” Professor Vincent said.
The continued follow-up of the 92 participants enrolled across the pivotal studies will provide Cochlear with additional data as it works toward future regulatory submissions.
Four Key Priorities Identified Through Development
Cochlear said its experience across three generations of fully implantable investigational systems has helped identify four key needs that future fully implantable hearing technology should address.
One priority is all-day hearing performance in everyday environments combined with implant battery longevity. For recipients, consistent hearing performance throughout the day is an important consideration, while battery performance is particularly relevant for an implanted system intended to support long-term daily use.
A second focus is internal dual-microphone technology. Cochlear said its development work has highlighted the potential importance of internal microphones designed to support body-noise cancellation while also contributing to surgical simplicity and streamlined programming.
The third priority involves familiar surgical techniques. Cochlear said future fully implantable systems should aim to use surgical approaches that minimize additional operating-room and anesthesia time. Integrating new technology into familiar surgical workflows may be an important consideration for both surgeons and healthcare systems.
The fourth priority is confidence supported by long-term clinical evidence, recipient insights and a large evidence base. Cochlear said the ongoing research program is intended to provide the data needed to understand both the performance of the technology and the experience of people using it.
Together, these priorities illustrate the company’s focus on developing a system that addresses not only the technological aspects of hearing implantation but also practical considerations related to surgery, programming, everyday use and long-term clinical performance.
Building Evidence Around Real-World Hearing Outcomes
The accumulation of more than 1 million hours of device experience across research participants provides Cochlear with an extensive body of experience as it evaluates fully implantable technology.
Clinical research in hearing technology must consider more than technical performance in controlled environments. People use hearing devices across a wide range of everyday situations, including conversations, workplaces, social environments and other settings in which background noise and changing acoustic conditions can affect hearing performance.
The ELEVATE and ENTERPRISE programs are therefore intended to contribute evidence about how fully implantable systems perform in real-world circumstances, alongside measures of safety and recipient outcomes.
The long-term follow-up of study participants will remain an important part of this process. Cochlear said data collection will continue following the completion of recruitment, with the findings expected to support the company’s development program as it moves toward regulatory submissions.
The company has not indicated that regulatory approval of a fully implantable system has been achieved through the latest recruitment milestone. Instead, the completion of recruitment represents a step in the clinical development process.
Experts Emphasize Current Treatment Options
While Cochlear is continuing to investigate fully implantable hearing technology, clinical experts involved in the research are emphasizing that people who currently need cochlear implants should not postpone established treatment while waiting for future technologies.
Professor Buchman noted that fully implantable systems are still being evaluated through clinical research and that existing cochlear implant technology is already available to patients who may benefit from it.
“Fully implantable technology holds great promise, but people who could benefit from a cochlear implant today should not wait for these future devices,” Professor Buchman said. “Current cochlear implant technology is proven and can provide meaningful access to sound, improvements in communication and quality of life now, while research into fully implantable systems continues.”
The comments distinguish the ongoing development of fully implantable systems from currently available cochlear implant technologies.
For people with significant hearing loss who may be candidates for cochlear implantation, treatment decisions remain a matter for discussion with qualified hearing healthcare professionals. The ongoing research into fully implantable systems does not change the availability of established cochlear implant technology today.
Cochlear Continues Development Toward Regulatory Submissions
With recruitment complete in both ELEVATE and ENTERPRISE, Cochlear is entering another phase of its fully implantable hearing technology development program.
The next stage will involve continued follow-up of the 92 patients enrolled in the pivotal studies and further analysis of clinical data. These activities are expected to contribute to Cochlear’s efforts toward future regulatory submissions.
The company’s progress is built on a research program extending back more than 20 years, including feasibility studies that began in 2005 and three generations of investigational fully implantable devices.
Cochlear’s latest milestone therefore reflects both the scale of its current clinical program and the company’s sustained investment in developing new approaches to hearing care.
The accumulation of more than 1 million hours of device experience provides an extensive foundation for understanding the technology, while the completed recruitment of the two pivotal studies brings the program closer to the regulatory stage.
Cochlear said it remains focused on developing technology that is safe, evidence-based and shaped by the needs of people living with hearing loss.
“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,” Howitt said.
The company’s latest commercially available cochlear implant technology is the Cochlear® Nucleus® Nexa® System. Meanwhile, research into fully implantable hearing technology continues through the ongoing follow-up and data collection activities associated with ELEVATE and ENTERPRISE.
As the pivotal program progresses, the resulting clinical evidence will help inform Cochlear’s next steps toward regulatory submissions and the potential future development of fully implantable hearing solutions.
About Cochlear’s fully implantable hearing system trials1
The ELEVATE and ENTERPRISE clinical trials are part of Cochlear’s pivotal research program evaluating the safety and effectiveness of an investigational totally implantable cochlear implant system in adults with moderately severe to profound hearing loss.
The ELEVATE study is being conducted in the United States and is designed to evaluate the investigational system in 56 adults across 11 clinical trial sites. The ENTERPRISE study is being conducted in Australia and France and is designed to evaluate the investigational system in 36 adults across five clinical trial sites.
Across both studies, 92 adults have been recruited to the pivotal program. A primary analysis of safety and effectiveness is planned at six months, with follow-up continuing to 12 months to collect additional longer-term data and insights.
Across Cochlear’s two pivotal studies and three feasibility studies, dating back to 2005, 117 patients have been enrolled.1-4
The investigational totally implantable cochlear implant system is not approved for commercial distribution. Safety and effectiveness have not yet been established. Regulatory evaluation will be required before the technology is approved for commercial availability.
About Cochlear Limited (ASX: COH)
People have always been Cochlear’s inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant after seeing his father struggle with hearing loss. Since 1981, Cochlear has helped more than 800,000 people of all ages in more than 180 countries to hear. As the global leader in implantable hearing solutions, Cochlear connects people with life’s opportunities, and welcomes them to the world’s largest hearing implant community.
Cochlear has a global workforce of more than 5,500 people with a passion for progress, who strive to meet the needs of people living with hearing loss. The company continually innovates to anticipate future needs, investing more than A$3 billion to date in research and development to push the boundaries of technology and help more people hear.