{"success":true,"data":{"pressRelease":{"id":"154476","rtpr_id":"nBw294lZra-20260928","ticker":"COH","exchange":"ASX","all_tickers":["COH"],"title":"Cochlear Reaches More Than 1 Million Hours of Patient Experience Across Its Fully Implantable Hearing Technology Research Program","author":"Business Wire","published_at":"2026-09-28T18:01:00.114Z","article_body":"Cochlear Reaches More Than 1 Million Hours of Patient Experience Across Its\nFully Implantable Hearing Technology Research Program\n\n\n * Global clinical studies advance Cochlear’s fully implantable hearing\ntechnology\n\n * US, European and Australian pivotal trial recruitment completed, and more than\n100 people implanted across the full research program\n\n * Program reflects Cochlear’s evidence-led approach to developing breakthrough\ntechnology focused on all-day hearing and implant battery longevity, surgical\nfamiliarity, microphone performance and trust through experience and evidence\n\nCochlear today announced the completion of recruitment for the worldwide\npivotal trial program evaluating fully implantable hearing technology.\nPatients across Cochlear’s fully implantable hearing system research\nprograms have experienced more than 1 million hours with their device to date.\n\nThis reflects the most comprehensive research program focused on fully\nimplantable hearing technology, underscoring Cochlear’s long-term commitment\nto this new category. Through a rigorous, evidence-led clinical program,\nCochlear is building a deeper understanding of the features, performance and\noutcomes that matter most to recipients, clinicians and health systems.\n\nCochlear said its global research program continues to progress, with\nrecruitment completed in the ELEVATE study across 11 sites in the US and in\nthe ENTERPRISE study across five sites in Europe and Australia. Ongoing\nfollow-up of the 92 patients in these studies and data collection activities\nwill continue as Cochlear advances its development program towards regulatory\nsubmissions.(1 )Including previous feasibility studies dating back to 2005,\nmore than 100 patients have received Cochlear fully implantable hearing\ntechnology.(1-4)\n\n“Fully implantable technology represents an exciting future direction for\nhearing care. We now have more than 20 years of experience across three\ngenerations of investigational devices. This has given us a strong\nunderstanding of what recipients and clinicians need in everyday life. We’re\ncommitted to delivering meaningful real-world benefits for recipients,” said\nDig Howitt, Cochlear’s chief executive officer and president.\n\nCochlear said lessons gained through three generations of development have\nhighlighted four critical patient and clinician needs for future fully\nimplantable hearing technology:\n\n\n * All-day hearing performance in everyday environments and implant battery\nlongevity\n\n * Internal dual-microphone technology designed for body noise cancellation,\nsurgical simplicity and streamlined programming\n\n * A familiar surgical technique to minimize additional theatre and anesthesia\ntime\n\n * Confidence based on long-term clinical data, recipient insights and a large\nevidence base\n\n“We are excited by the progress being made and remain focused on delivering\ntechnology that is safe, grounded in science and clinical evidence, and shaped\nby the needs of people living with hearing loss,” Howitt said.\n\nProfessor Craig Buchman, MD, FACS, professor of otolaryngology-head and neck\nsurgery at University of Utah Health and coordinating investigator of ELEVATE,\nsaid:\n\n“This pivotal program is building a robust evidence base on safety,\nperformance and recipient outcomes – critical to advancing fully implantable\nhearing technology with clinical confidence.”\n\nProfessor Christophe Vincent, head of otology and otoneurology at Lille\nUniversity Hospital and an investigator in the ENTERPRISE study, said:\n\n“ENTERPRISE will show how fully implantable hearing technology performs in\neveryday life and its potential to give people greater freedom and choice in\nhow they hear throughout the day.”\n\nWhile the technology is promising, clinical experts are emphasizing that\npatients should not delay treatment.\n\n“Fully implantable technology holds great promise, but people who could\nbenefit from a cochlear implant today should not wait for these future\ndevices. Current cochlear implant technology is proven and can provide\nmeaningful access to sound, improvements in communication and quality of life\nnow, while research into fully implantable systems continues,” Professor\nBuchman said.\n\nCochlear's latest commercially available cochlear implant technology is the\nCochlear(®) Nucleus(®) Nexa(®) System.\n\nAbout Cochlear’s fully implantable hearing system trials(1)\n\nThe ELEVATE and ENTERPRISE clinical trials are part of Cochlear’s pivotal\nresearch program evaluating the safety and effectiveness of an investigational\ntotally implantable cochlear implant system in adults with moderately severe\nto profound hearing loss.\n\nThe ELEVATE study is being conducted in the United States and is designed to\nevaluate the investigational system in 56 adults across 11 clinical trial\nsites. The ENTERPRISE study is being conducted in Australia and France and is\ndesigned to evaluate the investigational system in 36 adults across five\nclinical trial sites.\n\nAcross both studies, 92 adults have been recruited to the pivotal program. A\nprimary analysis of safety and effectiveness is planned at six months, with\nfollow-up continuing to 12 months to collect additional longer-term data and\ninsights.\n\nAcross Cochlear’s two pivotal studies and three feasibility studies, dating\nback to 2005, 117 patients have been enrolled.(1-4)\n\nThe investigational totally implantable cochlear implant system is not\napproved for commercial distribution. Safety and effectiveness have not yet\nbeen established. Regulatory evaluation will be required before the technology\nis approved for commercial availability.\n\nAbout Cochlear Limited (ASX: COH)\n\nPeople have always been Cochlear’s inspiration, ever since Professor Graeme\nClark set out to create the first multi-channel cochlear implant after seeing\nhis father struggle with hearing loss. Since 1981, Cochlear has helped more\nthan 800,000 people of all ages in more than 180 countries to hear. As the\nglobal leader in implantable hearing solutions, Cochlear connects people with\nlife’s opportunities, and welcomes them to the world’s largest hearing\nimplant community.\n\nCochlear has a global workforce of more than 5,500 people with a passion for\nprogress, who strive to meet the needs of people living with hearing loss. The\ncompany continually innovates to anticipate future needs, investing more than\nA$3 billion to date in research and development to push the boundaries of\ntechnology and help more people hear.\n\nwww.cochlear.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.cochlear.com&esheet=54612162&newsitemid=20260928955470&lan=en-US&anchor=www.cochlear.com&index=1&md5=3ad225ee09e530334c8d29781b39e7c7)\n\nReferences\n\n\n 1. ClinicalTrials.gov NCT07139327 and NCT07287124. Available at \nhttps://clinicaltrials.gov/study/NCT07139327\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07139327&esheet=54612162&newsitemid=20260928955470&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07139327&index=2&md5=4e08530af293419ffc5d43a0a921caae)\n\nand \nhttps://clinicaltrials.gov/study/NCT07287124\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07287124&esheet=54612162&newsitemid=20260928955470&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07287124&index=3&md5=8ebcbd2bdb955c847c88d4647eea1491)\n\n 2. Briggs RJ, Eder HC, Seligman PM, et al. Initial clinical experience with a\ntotally implantable cochlear implant research device. Otol Neurotol. 2008\nFeb;29(2):114-9.\n\n 3. Briggs R, Tari S, Rousset A, English R, Hersbach A, Cowan R. Evaluation of a\nTotally Implantable Cochlear Implant in Adults With Bilateral Sensorineural\nHearing Loss: A Feasibility Study. Ear Hear. 2025 Nov 17. Epub ahead of print.\nPMID: 41243136.\n\n 4. ClinicalTrials.gov. A study to explore improved features and a simplified\ntreatment approach for a totally implantable cochlear implant (TICI) research\nsystem in adults with severe hearing loss. Available at \nhttps://www.clinicaltrials.gov/study/NCT06642935\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06642935&esheet=54612162&newsitemid=20260928955470&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06642935&index=4&md5=3b5866155c0af1a54012f76f4601847e)\n\n[last accessed July 2025].\n\nThis material is intended for health professionals. If you are a consumer,\nplease seek advice from your health professional about treatments for hearing\nloss. Outcomes may vary, and your health professional will advise you about\nthe factors which could affect your outcome. Always read the instructions for\nuse. Not all products are available in all countries. Please contact your\nlocal Cochlear representative for product information.\n\nCochlear, Hear now. And always, Nucleus, Nexa and the elliptical logo are\neither trademarks or registered trademarks of the Cochlear group of companies.\n\n© Cochlear Limited 2026. All rights reserved.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260928955470/en/\n(https://www.businesswire.com/news/home/20260928955470/en/)\n\nFor further information, please contact: \n\nChristy LaPlante\n\nPublic Relations Manager\n\nEmail: pr-cochlearamericas@cochlear.com\n(mailto:pr-cochlearamericas@cochlear.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw294lZra-20260928","title":"Cochlear Reaches More Than 1 Million Hours of Patient Experience Across Its Fully Implantable Hearing Technology Research Program","author":"Business Wire","ticker":"COH","created":"2026-09-28T18:01:00.114Z","tickers":["COH"],"exchange":"ASX","article_body":"Cochlear Reaches More Than 1 Million Hours of Patient Experience Across Its\nFully Implantable Hearing Technology Research Program\n\n\n * Global clinical studies advance Cochlear’s fully implantable hearing\ntechnology\n\n * US, European and Australian pivotal trial recruitment completed, and more than\n100 people implanted across the full research program\n\n * Program reflects Cochlear’s evidence-led approach to developing breakthrough\ntechnology focused on all-day hearing and implant battery longevity, surgical\nfamiliarity, microphone performance and trust through experience and evidence\n\nCochlear today announced the completion of recruitment for the worldwide\npivotal trial program evaluating fully implantable hearing technology.\nPatients across Cochlear’s fully implantable hearing system research\nprograms have experienced more than 1 million hours with their device to date.\n\nThis reflects the most comprehensive research program focused on fully\nimplantable hearing technology, underscoring Cochlear’s long-term commitment\nto this new category. Through a rigorous, evidence-led clinical program,\nCochlear is building a deeper understanding of the features, performance and\noutcomes that matter most to recipients, clinicians and health systems.\n\nCochlear said its global research program continues to progress, with\nrecruitment completed in the ELEVATE study across 11 sites in the US and in\nthe ENTERPRISE study across five sites in Europe and Australia. Ongoing\nfollow-up of the 92 patients in these studies and data collection activities\nwill continue as Cochlear advances its development program towards regulatory\nsubmissions.(1 )Including previous feasibility studies dating back to 2005,\nmore than 100 patients have received Cochlear fully implantable hearing\ntechnology.(1-4)\n\n“Fully implantable technology represents an exciting future direction for\nhearing care. We now have more than 20 years of experience across three\ngenerations of investigational devices. This has given us a strong\nunderstanding of what recipients and clinicians need in everyday life. We’re\ncommitted to delivering meaningful real-world benefits for recipients,” said\nDig Howitt, Cochlear’s chief executive officer and president.\n\nCochlear said lessons gained through three generations of development have\nhighlighted four critical patient and clinician needs for future fully\nimplantable hearing technology:\n\n\n * All-day hearing performance in everyday environments and implant battery\nlongevity\n\n * Internal dual-microphone technology designed for body noise cancellation,\nsurgical simplicity and streamlined programming\n\n * A familiar surgical technique to minimize additional theatre and anesthesia\ntime\n\n * Confidence based on long-term clinical data, recipient insights and a large\nevidence base\n\n“We are excited by the progress being made and remain focused on delivering\ntechnology that is safe, grounded in science and clinical evidence, and shaped\nby the needs of people living with hearing loss,” Howitt said.\n\nProfessor Craig Buchman, MD, FACS, professor of otolaryngology-head and neck\nsurgery at University of Utah Health and coordinating investigator of ELEVATE,\nsaid:\n\n“This pivotal program is building a robust evidence base on safety,\nperformance and recipient outcomes – critical to advancing fully implantable\nhearing technology with clinical confidence.”\n\nProfessor Christophe Vincent, head of otology and otoneurology at Lille\nUniversity Hospital and an investigator in the ENTERPRISE study, said:\n\n“ENTERPRISE will show how fully implantable hearing technology performs in\neveryday life and its potential to give people greater freedom and choice in\nhow they hear throughout the day.”\n\nWhile the technology is promising, clinical experts are emphasizing that\npatients should not delay treatment.\n\n“Fully implantable technology holds great promise, but people who could\nbenefit from a cochlear implant today should not wait for these future\ndevices. Current cochlear implant technology is proven and can provide\nmeaningful access to sound, improvements in communication and quality of life\nnow, while research into fully implantable systems continues,” Professor\nBuchman said.\n\nCochlear's latest commercially available cochlear implant technology is the\nCochlear(®) Nucleus(®) Nexa(®) System.\n\nAbout Cochlear’s fully implantable hearing system trials(1)\n\nThe ELEVATE and ENTERPRISE clinical trials are part of Cochlear’s pivotal\nresearch program evaluating the safety and effectiveness of an investigational\ntotally implantable cochlear implant system in adults with moderately severe\nto profound hearing loss.\n\nThe ELEVATE study is being conducted in the United States and is designed to\nevaluate the investigational system in 56 adults across 11 clinical trial\nsites. The ENTERPRISE study is being conducted in Australia and France and is\ndesigned to evaluate the investigational system in 36 adults across five\nclinical trial sites.\n\nAcross both studies, 92 adults have been recruited to the pivotal program. A\nprimary analysis of safety and effectiveness is planned at six months, with\nfollow-up continuing to 12 months to collect additional longer-term data and\ninsights.\n\nAcross Cochlear’s two pivotal studies and three feasibility studies, dating\nback to 2005, 117 patients have been enrolled.(1-4)\n\nThe investigational totally implantable cochlear implant system is not\napproved for commercial distribution. Safety and effectiveness have not yet\nbeen established. Regulatory evaluation will be required before the technology\nis approved for commercial availability.\n\nAbout Cochlear Limited (ASX: COH)\n\nPeople have always been Cochlear’s inspiration, ever since Professor Graeme\nClark set out to create the first multi-channel cochlear implant after seeing\nhis father struggle with hearing loss. Since 1981, Cochlear has helped more\nthan 800,000 people of all ages in more than 180 countries to hear. As the\nglobal leader in implantable hearing solutions, Cochlear connects people with\nlife’s opportunities, and welcomes them to the world’s largest hearing\nimplant community.\n\nCochlear has a global workforce of more than 5,500 people with a passion for\nprogress, who strive to meet the needs of people living with hearing loss. The\ncompany continually innovates to anticipate future needs, investing more than\nA$3 billion to date in research and development to push the boundaries of\ntechnology and help more people hear.\n\nwww.cochlear.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.cochlear.com&esheet=54612162&newsitemid=20260928955470&lan=en-US&anchor=www.cochlear.com&index=1&md5=3ad225ee09e530334c8d29781b39e7c7)\n\nReferences\n\n\n 1. ClinicalTrials.gov NCT07139327 and NCT07287124. Available at \nhttps://clinicaltrials.gov/study/NCT07139327\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07139327&esheet=54612162&newsitemid=20260928955470&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07139327&index=2&md5=4e08530af293419ffc5d43a0a921caae)\n\nand \nhttps://clinicaltrials.gov/study/NCT07287124\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07287124&esheet=54612162&newsitemid=20260928955470&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07287124&index=3&md5=8ebcbd2bdb955c847c88d4647eea1491)\n\n 2. Briggs RJ, Eder HC, Seligman PM, et al. Initial clinical experience with a\ntotally implantable cochlear implant research device. Otol Neurotol. 2008\nFeb;29(2):114-9.\n\n 3. Briggs R, Tari S, Rousset A, English R, Hersbach A, Cowan R. Evaluation of a\nTotally Implantable Cochlear Implant in Adults With Bilateral Sensorineural\nHearing Loss: A Feasibility Study. Ear Hear. 2025 Nov 17. Epub ahead of print.\nPMID: 41243136.\n\n 4. ClinicalTrials.gov. A study to explore improved features and a simplified\ntreatment approach for a totally implantable cochlear implant (TICI) research\nsystem in adults with severe hearing loss. Available at \nhttps://www.clinicaltrials.gov/study/NCT06642935\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06642935&esheet=54612162&newsitemid=20260928955470&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06642935&index=4&md5=3b5866155c0af1a54012f76f4601847e)\n\n[last accessed July 2025].\n\nThis material is intended for health professionals. If you are a consumer,\nplease seek advice from your health professional about treatments for hearing\nloss. Outcomes may vary, and your health professional will advise you about\nthe factors which could affect your outcome. Always read the instructions for\nuse. Not all products are available in all countries. Please contact your\nlocal Cochlear representative for product information.\n\nCochlear, Hear now. And always, Nucleus, Nexa and the elliptical logo are\neither trademarks or registered trademarks of the Cochlear group of companies.\n\n© Cochlear Limited 2026. All rights reserved.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260928955470/en/\n(https://www.businesswire.com/news/home/20260928955470/en/)\n\nFor further information, please contact: \n\nChristy LaPlante\n\nPublic Relations Manager\n\nEmail: pr-cochlearamericas@cochlear.com\n(mailto:pr-cochlearamericas@cochlear.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-09-28T18:01:00.168932091Z","server_sent_at_ms":1790618460168},"received_at":"2026-09-28T18:01:00.253Z","source_url":"https://www.businesswire.com/news/home/20260928955470/en/"},"analysis":{"id":"143241","press_release_id":"154476","analysis_json":{"industry":{"label":"Health Care Equipment & Supplies","sector":"Health Care"},"redFlags":["Investigational system is not approved; regulatory submissions still pending and safety/effectiveness not yet established"],"eventType":"clinical_trial","narrative":"Cochlear completed recruitment for its global pivotal trial program evaluating fully implantable hearing technology, with 92 adults enrolled across the ELEVATE (US) and ENTERPRISE (Europe/Australia) studies.\n\nPatients have now logged more than 1 million cumulative hours with the investigational device, and including feasibility studies dating to 2005, 117 patients have been enrolled across the research program.\n\nPrimary six-month safety and effectiveness analysis is planned, followed by regulatory submissions; the system is not yet approved for commercial distribution, so the milestone is developmental rather than a near-term revenue event.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Pivotal recruitment complete on fully implantable cochlear implant -- watch for six-month primary analysis data readout."},"keyFigures":{"drugName":"investigational totally implantable cochlear implant system","phaseOfTrial":"pivotal (ELEVATE and ENTERPRISE)","customDimensions":{"elevate_sites":11,"patient_hours":"more than 1 million","elevate_target":56,"followup_months":12,"enterprise_sites":5,"enterprise_target":36,"primary_analysis_months":6,"pivotal_patients_recruited":92,"total_patients_enrolled_since_2005":117}},"quotedText":"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.","namedEntities":{"people":[{"name":"Dig Howitt","role":"CEO and President of Cochlear"},{"name":"Craig Buchman","role":"Professor of otolaryngology, University of Utah Health; ELEVATE coordinating investigator"},{"name":"Christophe Vincent","role":"Head of otology and otoneurology, Lille University Hospital; ENTERPRISE investigator"},{"name":"Christy LaPlante","role":"Public Relations Manager, Cochlear"}],"products":["Cochlear Nucleus Nexa System","ELEVATE study","ENTERPRISE study"],"companies":[{"name":"Cochlear Limited","ticker":"COH","relationship":"filer"},{"name":"University of Utah Health","relationship":"clinical investigator site"},{"name":"Lille University Hospital","relationship":"clinical investigator site"}],"dollarAmounts":[{"amount":"A$3 billion","context":"cumulative R&D investment to date"}]},"materialImpact":{"score":2,"reasoning":"Pivotal trial recruitment completion and 1M+ cumulative patient-device hours are a positive development milestone, but the fully implantable system is still investigational, not approved, and years from revenue. Regulatory submissions are still pending."},"tickerRelevance":{"others":[],"primary":"COH"},"globalImportance":22,"audienceRelevance":12,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"large-cap ASX medtech leader","eventGravity":"trial recruitment milestone, no data readout","revenueProximity":"multi-year from commercialization","retailFavoriteBoost":false}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Cochlear completed recruitment for its global pivotal trial program evaluating fully implantable hearing technology, with 92 adults enrolled across the ELEVATE (US) and ENTERPRISE (Europe/Australia) studies.\n\nPatients have now logged more than 1 million cumulative hours with the investigational device, and including feasibility studies dating to 2005, 117 patients have been enrolled across the research program.\n\nPrimary six-month safety and effectiveness analysis is planned, followed by regulatory submissions; the system is not yet approved for commercial distribution, so the milestone is developmental rather than a near-term revenue event.","key_figures":{"drugName":"investigational totally implantable cochlear implant system","phaseOfTrial":"pivotal (ELEVATE and ENTERPRISE)","customDimensions":{"elevate_sites":11,"patient_hours":"more than 1 million","elevate_target":56,"followup_months":12,"enterprise_sites":5,"enterprise_target":36,"primary_analysis_months":6,"pivotal_patients_recruited":92,"total_patients_enrolled_since_2005":117}},"named_entities":{"people":[{"name":"Dig Howitt","role":"CEO and President of Cochlear"},{"name":"Craig Buchman","role":"Professor of otolaryngology, University of Utah Health; ELEVATE coordinating investigator"},{"name":"Christophe Vincent","role":"Head of otology and otoneurology, Lille University Hospital; ENTERPRISE investigator"},{"name":"Christy LaPlante","role":"Public Relations Manager, Cochlear"}],"products":["Cochlear Nucleus Nexa System","ELEVATE study","ENTERPRISE study"],"companies":[{"name":"Cochlear Limited","ticker":"COH","relationship":"filer"},{"name":"University of Utah Health","relationship":"clinical investigator site"},{"name":"Lille University Hospital","relationship":"clinical investigator site"}],"dollarAmounts":[{"amount":"A$3 billion","context":"cumulative R&D investment to date"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-28T18:01:06.780Z","global_importance":22,"audience_relevance":12,"importance_components":{"tickerTier":"large-cap ASX medtech leader","eventGravity":"trial recruitment milestone, no data readout","revenueProximity":"multi-year from commercialization","retailFavoriteBoost":false}},"durationMs":6479,"modelName":"glm-5.3-flashx"}}