SYDNEY, AUSTRALIA — Cochlear has reached a new milestone in the development of its fully implantable hearing technology, with patients across the company’s research programs now accumulating more than 1 million hours of experience with investigational devices.
The company also announced that recruitment has been completed for its global pivotal trial program, including the ELEVATE study in the United States and the ENTERPRISE study in Europe and Australia. Together, the two studies include 92 adults, while more than 100 people have received Cochlear’s fully implantable hearing technology across three generations of investigational devices dating back to 2005.1-4
Cochlear said the research program is intended to build evidence around the safety, performance, and real-world use of fully implantable hearing technology while identifying the features and outcomes that matter most to recipients, clinicians, and health systems.
“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.”
— Dig Howitt, Chief Executive Officer and President, Cochlear
Focus on All-Day Hearing and Real-World Use
According to Cochlear, experience across three generations of development has helped identify four areas of focus for future fully implantable hearing technology: all-day hearing performance and implant battery longevity; internal dual-microphone technology designed for body noise cancellation; surgical simplicity and streamlined programming; and confidence supported by long-term clinical data and recipient experience.
The company is also seeking to maintain a familiar surgical approach that minimizes additional operating room and anesthesia time.
“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.
ELEVATE and ENTERPRISE Pivotal Studies
The ELEVATE and ENTERPRISE trials are evaluating the safety and effectiveness of an investigational totally implantable cochlear implant system in adults with moderately severe to profound hearing loss.1
ELEVATE is being conducted at 11 clinical trial sites in the United States and includes 56 adults. ENTERPRISE includes 36 adults across five sites in Australia and France. Recruitment for both studies is now complete, with ongoing follow-up and data collection continuing as Cochlear works toward potential regulatory submissions.
A primary analysis of safety and effectiveness is planned at six months, with participants followed for 12 months to collect additional longer-term data and insights.
Across the two pivotal studies and three earlier feasibility studies dating to 2005, 117 patients have been enrolled in Cochlear’s fully implantable hearing technology research program.1-4
“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 Craig Buchman, MD, FACS, University of Utah Health
Professor Christophe Vincent, head of otology and otoneurology at Lille University Hospital and an investigator in the ENTERPRISE study, said the trial will provide additional information about how the technology performs outside the clinic.
“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,” Vincent said.
Investigational Technology Remains Under Study
Cochlear and participating investigators emphasized that the fully implantable system remains investigational and is not approved for commercial distribution. Its safety and effectiveness have not yet been established, and regulatory evaluation will be required before any commercial availability.
Buchman also cautioned that people who currently qualify for cochlear implantation should not postpone treatment while fully implantable systems remain under development.
“Fully implantable technology holds great promise, but people who could benefit from a cochlear implant today should not wait for these future devices. 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,” he said.
Cochlear’s latest commercially available cochlear implant technology is the Cochlear® Nucleus® Nexa® System.
About Cochlear
Cochlear Limited (ASX: COH) develops implantable hearing solutions and has provided hearing technologies to more than 800,000 people in more than 180 countries since 1981. The company employs more than 5,500 people globally and reports investing more than A$3 billion in research and development to date.
References
1. ClinicalTrials.gov. NCT07139327 and NCT07287124.
2. Briggs RJ, Eder HC, Seligman PM, et al. Initial clinical experience with a totally implantable cochlear implant research device. Otol Neurotol. 2008;29(2):114-119.
3. Briggs R, Tari S, Rousset A, English R, Hersbach A, Cowan R. Evaluation of a Totally Implantable Cochlear Implant in Adults With Bilateral Sensorineural Hearing Loss: A Feasibility Study. Ear Hear. 2025 Nov 17. Epub ahead of print. PMID: 41243136.
4. ClinicalTrials.gov. A study to explore improved features and a simplified treatment approach for a totally implantable cochlear implant (TICI) research system in adults with severe hearing loss. NCT06642935.
**Cochlear, Hear now. And always, Nucleus, Nexa and the elliptical logo are either trademarks or registered trademarks of the Cochlear group of companies.
