Cochlear today announced the completion of recruitment for the worldwide pivotal trial program evaluating fully implantable hearing technology. Patients across Cochlear’s fully implantable hearing system research programs have experienced more than 1 million hours with their device to date.

This reflects the most comprehensive research program focused on fully implantable hearing technology, underscoring Cochlear’s long-term commitment to this new category. Through a rigorous, evidence-led clinical program, Cochlear is building a deeper understanding of the features, performance and outcomes that matter most to recipients, clinicians and health systems.

Cochlear said its global research program continues to progress, with recruitment completed in the ELEVATE study across 11 sites in the US and in the ENTERPRISE study across five sites in Europe and Australia. Ongoing follow-up of the 92 patients in these studies and data collection activities will continue as Cochlear advances its development program towards regulatory submissions.1 Including previous feasibility studies dating back to 2005, more than 100 patients have received Cochlear fully implantable hearing technology.1-4

“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.

Cochlear said lessons gained through three generations of development have highlighted four critical patient and clinician needs for future fully implantable hearing technology:

  • 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 to minimize additional theatre and anesthesia time

  • Confidence based on long-term clinical data, recipient insights and a large evidence base

“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.

Professor Craig Buchman, MD, FACS, professor of otolaryngology-head and neck surgery at University of Utah Health and coordinating investigator of ELEVATE, said:

“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 Christophe Vincent, head of otology and otoneurology at Lille University Hospital and an investigator in the ENTERPRISE study, said:

“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.”

While the technology is promising, clinical experts are emphasizing that patients should not delay treatment.

“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,” Professor Buchman said.

Cochlear’s latest commercially available cochlear implant technology is the Cochlear® Nucleus® Nexa® System.

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.

www.cochlear.com

References

  1. ClinicalTrials.gov NCT07139327 and NCT07287124. Available at https://clinicaltrials.gov/study/NCT07139327 and https://clinicaltrials.gov/study/NCT07287124

  2. Briggs RJ, Eder HC, Seligman PM, et al. Initial clinical experience with a totally implantable cochlear implant research device. Otol Neurotol. 2008 Feb;29(2):114-9.

  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. Available at https://www.clinicaltrials.gov/study/NCT06642935 [last accessed July 2025].

This material is intended for health professionals. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

Cochlear, Hear now. And always, Nucleus, Nexa and the elliptical logo are either trademarks or registered trademarks of the Cochlear group of companies.

© Cochlear Limited 2026. All rights reserved.

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