COCHLEAR™ NUCLEUS®
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COCHLEAR ™ NUCLEUS ® RELIABILITY REPORT

Holly Taylor Cochlear recipient since 1987

OUR MISSION We help people hear and be heard. We empower people to connect with others and live a full life. We transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes. Cochlear’s implants are the most reliable in the industry. That’s one reason why more people choose Cochlear than any other implant brand. COCHLEAR'S IMPLANTS ARE THE MOST RELIABLE IN THE INDUSTRY Cochlear Nucleus Reliability Report | February 2015

WHY RELIABILITY MATTERS High implant reliability means greater patient satisfaction and less risk of additional surgery. When considering which implant is right for your patient, it's important that you have access to the latest data on short- and long-term reliability, success and failure rates and key implant features. These are outlined in this Reliability Report. ABOUT RELIABILITY REPORTING The global standards for cochlear implant reliability reporting are the International Standard ISO 5841-2:2000 1, the reporting principles outlined in the European Consensus Statement on Cochlear...

HOW TO READ THIS REPORT What is Cumulative Survival Percentage (CSP)? What data is in this report? The cumulative percentage of functioning implants over time, which can be used to predict the reliability of the device within a given time period. The data in this report cover the entire life of implant models and registered implants* worldwide. The reliability calculations used in this report are in accordance with the ISO 58412:2000 Standard.1 They are probability calculations, which use a modified KaplanMeier estimator. These data estimate the probability of survival within a period of...

FULL COMPLIANCE WITH INTERNATIONAL REPORTING STANDARDS In 2005, the major European cochlear implant centres, global regulatory authorities and device manufacturers developed the European and Global Consensus Statement on Cochlear Implant Failures and Explantations.2 The Consensus Statement outlines how device failures and reliability should be reported, and the seven principles of best practice reporting. Cochlear is the only hearing implant company that fully complies with the international reporting standards. CONSENSUS STATEMENT PRINCIPLE All device failures must be reported to the...

COCHLEAR REPORTING PRACTICE COCHLEAR COMPLIANCE Sample size not included. Sample size not included. All device failures are reported to the competent authority. Cochlear uses the applicable definitions, categorisation scheme and calculation procedures of ISO 5841-2:2000.1 All device failure modes are included, including failures due to external impact. The source of data is Cochlear’s global complaints handling database. Sample size and time period are specified with each report. All models and all versions of each model are included in reports. Descriptions of any significant technical...

MORE PEOPLE CHOOSE COCHLEAR THAN ANY OTHER IMPLANT BRAND OVER 260,000 REGISTERED COCHLEAR™ NUCLEUS® IMPLANTS WORLDWIDE Number of registered implants - 23 February 2015 DEVICE Cumulative Survival Percentage (CSP) data for combined adults and children YEARS Cochlear Nucleus Reliability Report | February 2015

Nucleus Implant Reliability Cumulative Survival Percentage of Implants Previous generation implant Current generation implant PROFILE 100% CSP WITHIN ONE YEAR CI24RE 99.1% CSP WITHIN 11 YEARS Time in Years REGISTERED IMPLANT DATA COMBINED FOR ADULTS AND CHILDREN AS OF 23 FEBRUARY 2015 * Voluntarily recalled in September 2011. Cochlear Nucleus Reliability Report | February 2015

Leah Allion Cochlear recipient since 2007

CURRENT GENERATION IMPLANT DATA Cochlear Nucleus Reliability Report | February 2015

NUCLEUS PROFILE SERIES IMPLANT Number of registered Profile Series implants - 23 February 2015 ADULTS At only 3.9 mm, the thin implant body of the Profile Series is the most discreet choice for all patients. The implant also offers ease of use and faster surgery due to minimal drilling. Commercially released in 2014, the Profile Series sets a new standard in implant reliability with a 100% combined Cumulative Survival Percentage within one year. Profile Series Cumulative Survival Percentage* YEAR * One device has been explanted since the date of this report. The reason for the explant is...

Prole Series Reliability Adults and Children Cumulative Survival Percentage of Implants PROFILE: OVER 1,800 DEVICES IMPLANTED Time in Years REGISTERED IMPLANT DATA FOR ADULTS AND CHILDREN AS OF 23 FEBRUARY 2015 (No condence interval presented in this chart due to 100% Cumulative Survival Percentage) Cochlear Nucleus Reliability Report | February 2015

NUCLEUS CI24RE SERIES IMPLANT Number of registered CI24RE Series implants - 23 February 2015 ADULTS CHILDREN COMBINED The CI24RE Series is the world's most widely used cochlear implant. Released in 2005, it has a record of 99.1% combined Cumulative Survival Percentage within 11 years. CI24RE Series Cumulative Survival Percentage # Individual populations less than the minimum required for a valid calculation. Cochlear Nucleus Reliability Report | February 2015

Cumulative Survival Percentage of Implants CI24RE: OVER 137,000 DEVICES IMPLANTED Time in Years REGISTERED IMPLANT DATA FOR ADULTS AND CHILDREN AS OF 23 FEBRUARY 2015 Cochlear Nucleus Reliability Report | February 2015

Professor Graeme Clark Creator of the multi-channel cochlear implant Rod Saunders First research multi-channel cochlear implant recipient, 1978

PREVIOUS GENERATION 17 IMPLANT DATA Cochlear Nucleus Reliability Report | February 2015

NUCLEUS CI500 SERIES IMPLANT Number of registered CI500 Series implants - 23 February 2015 ADULTS Released in 2009, the CI500 Series has a combined Cumulative Survival Percentage of 92.3% within six years. The CI500 Series was voluntarily recalled in September 2011. CI500 Series Cumulative Survival Percentage YEARS Cochlear Nucleus Reliability Report | February 2015