2019 Global Implant Reliability Report
1 / 13Páginas

2019 Global Implant Reliability Report

My parents originally chose AB because of it’s dependability, ongoing research to upgrade and the support team behind AB (BEA) to help us through the process. When I was older, I chose to go bilateral and stay with AB for the same reasons. I saw that over the years with AB that they are dedicated to their product and are continually striving for ways to help their customers hear better through different sound strategies and processor upgrades. — Alexandra L., AB Recipient Our Mission RELIABLE, HIGH-QUALITY HEARING SOLUTIONS FOR A LIFETIME OF BETTER HEARING At Advanced Bionics, we’re...

TRANSPARENT REPORTING ON IMPLANT RELIABILITY As part of our commitment to providing clear and accurate information, Advanced Bionics reports all device failures in adherence to the global standard as defined by ISO 5841 – 2:20141 and the principles outlined in the European & Global Consensus on Cochlear Implant Failures and Explantations.2 Even though all manufacturers adhere to these standards, other manufacturers may report using different definitions of what constitutes a device failure, and therefore not include the same types of information in their reliability statistics. IMPORTANT...

ADVANCED BIONICS COMMITMENT ADVANCED BIONICS All device failures must be reported to the competent authority and must be included in the calculation of the cumulative survival rate (CSR). Reporting of the CSR should be in accordance with ISO standard 5841–2:20001. Accident related device failures are included in our standard CSR calculations. Extensive failure analysis including hermeticity on all medical and non-medical returns. Hermeticity is specifically measured on every implant return. Manufacturers reports of device failure should indicate the sources of data and the sample size....

Finding the right solution for your hearing needs takes careful research. But since every cochlear implant manufacturer has a different approach to the evaluation of explanted and returned devices (as well as their reliability reporting practices), it can be difficult to get truly accurate, “apples-to-apples” product comparisons. Since I’m a triathlete, perspiration and contact with water is unavoidable in my life. Since I had been told that a completely waterproof cochlear implant would one day become available, I chose Advanced Bionics without hesitation. — Kato-san, AB recipient Advanced...

HiRes™ Ultra 3D Cochlear Implant HASSLE FREE, PAIN FREE MRI, UNINTERRUPTED HEARING The HiRes Ultra 3D implant is the newest member of the HiRes implant family. It is one of the first cochlear implants that allows users access to a MRI without head bandaging or magnet removal surgery. It’s highly likely that everyone will get an MRI at some time in their life7 and we know that 70% of recipients experience pain8 when undergoing an MRI normally. The HiRes Ultra 3D was created in order to address this important clinical need and provides our recipients with access to a pain-free and hassle-free...

HiRes™ Ultra Cochlear Implant Number of registered HiRes Ultra cochlear implants as of July 15, 2019 ADULTS THE INDUSTRY’S MOST FLEXIBLE AND DURABLE HIGH-PERFORMANCE IMPLANT Date of first commercial introduction: 2016 did you know?... THE IMPLANT HAS ONLY 0.0001% HiRes Ultra OXYGEN TO PREVENT THE ELECTRONICS FROM OXIDIZING. 100.00% Adults Combined Adults Combined Children The HiRes Ultra offers a thin, discreet design suitable for adults and children. It is designed to exceed industry standards for impact resistance, offering users greater peace of mind while wearing their implant. The...

PREVIOUS-GENERATION IMPLANT DATA The AB cochlear implant has given me an opportunity to live life to its fullest. Because of my CI, I can more fully participate in my children’s lives and enjoy the sounds of their childhood. — Scott H., AB Recipient HiRes 90K™ Advantage Cochlear Implant did you know?... The HiRes 90K Advantage implant offers users access to some of the best sound processing technology available. It also offers surgeons the ability to create a deeper bone bed in order to secure the implant. Available with a variety of electrode options, the HiRes 90K advantage offers...

HiRes 90K™ Cochlear Implant The HiRes 90K implant, the precursor to the HiRes 90K advantage implant, offers users access to advanced sound processing technology. It’s been approved for MRI and can undergo 1.5T MRI scans with the magnet removed. The HiRes 90K implant has had manufacturing modifications—the version that is currently available is termed the HiRes 90K (vendor A post-mod) implant. did you know?... AB IS PART OF THE SONOVA GROUP OF COMPANIES. TOGETHER WITH OUR SISTER COMPANY, PHONAK, WE HAVE COMBINED TO BRING STATE-OF-THE-ART SOLUTIONS FROM THE HEARING AID FIELD TO COCHLEAR...

Number of registered HiRes 90K (Vendor A All) implants as of July 15, 2019 Number of registered HiRes 90K (Vendor A Pre Mod) implants as of July 15, 2019 Last year of distribution9: Still available in select markets Last year of distribution9: Still available in select markets HiRes 90K™ (Vendor A- Pre and Post Mod) 100.00% 82.00% 80.00% Adults Combined Children 82.00% 80.00% Adults Combined Children I chose AB after extensive research as I felt their CI and processor technology would deliver the best sound quality. As a musician, sound quality is important. AB’s CI system allows me to hear...

THE CLARION FAMILY OF IMPLANTS The CII implant provided the basis for the technology behind our latest series of implants and continues to provide access to the latest innovations in sound processing strategies and sound processors. It benefits from the generational improvements to the ceramic injection molding technology used in the earlier C1.2 implants. Number of registered HiRes 90K (Vendor B) implants as of July 15, 2019 Adults Number of registered CII implants - July15, 2019 Last year of distribution9: 2006 (Implant Voluntarily Recalled in 2006) HiRes 90K™ (Vendor B) Clarion CII...