2017 Global Implant Reliability Report

Transcription

1 0 Global Implant Reliability Report 0 Global Implant Reliability Report Advanced Bionics AG Laubisrütistrasse, Stäfa, Switzerland T: F: info.switzerland@advancedbionics.com 0 Global Implant Reliability Report Advanced Bionics LLC Westinghouse Place Valencia, CA, United States T: T: F: info.us@advancedbionics.com A Sonova brand For information on additional AB locations, please visit AdvancedBionics.com/contact To learn more about the unique advantages of hearing with Advanced Bionics, call.. (HEAR), hear@advancedbionics.com, or visit AdvancedBionics.com. * Implants registered without DOB information are included in data but cannot be classified as Adult or Child. Implant data also includes those implants implanted during clinical trials.. ISO - (0) Implants for surgery cardiac pacemakers. International Organization for Standardization (ISO), Geneva, Switzerland.. European Consensus Statement on Cochlear Implant Failures and Explantations. (00) Otology and Neurotology, (): All data contained in this report is valid as of July, 0.. EN 0--:00. Active Implantable Medical Devices. Particular Requirements for Cochlear and Auditory Brainstem Implant Systems.. Dates provided are those for major markets covered by FDA and TÜV regulation. HiRes Ultra and HiRes 0K Advantage implants, may be pending approval in a small subset of additional regions. The AB recipients, their family members, and friends featured in this report have not been compensated for the use of their image in this material. Pictured on the cover: Scott H., AB Recipient with his family 0-N0-0 0 Advanced Bionics AG and affiliates. All rights reserved. A Sonova brand

2 0 Global Implant Reliability Report 0 Global Implant Reliability Report Our Mission At Advanced Bionics we are dedicated to providing quality products and services so that everyone may enjoy the delight of hearing. Our commitment to putting patients first and providing the best possible hearing performance remains at the forefront of all that we do. The trust patients place in us inspires us to act with integrity and transparency as we strive for excellence each and every day in all that we do. Reporting Principle Report all device failures in adherence to the global standard as defined by ISO -:0. Report to the seven principles of best practice reporting as outlined in the European & Global Consensus on Cochlear Implant Failures and Explantations. Sample size and time period are specified for each reported implant. AB differentiates all implant and electrode types with unique model numbers and they all gain independent FDA and CE mark regulatory approval. Advanced Bionics Commitment 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 -:0 and the principles outlined in the European & Global Consensus on Cochlear Implant Failures and Explantations. 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. Advanced Bionics is committed to providing patients and professionals with the most complete reports, in an easy-to-interpret format, with data presented clearly and transparently. AB reports on specific device information (for example, HiRes 0K Vendor A and Vendor B devices) and will continue to do so. Reports show separate data for adults and children. % confidence intervals are clearly and visually indicated for every graph. All failures are counted that occur any time after wound closure. Actual values presented for all implants, all generations, no computer-generated modeling data are used.

3 0 Global Implant Reliability Report 0 Global Implant Reliability Report Important Tips for Reading the Tables and Graphs in this Report The number of registered users are shown for adults, children and as a combined number. This does not represent all devices sold/implanted. The combined number also includes any registered users that we do not have date of birth information. Number of registered HiRes 0K Advantage implants as of July, 0,,,* Date of first commercial introduction: 0 The AB Difference As a hearing healthcare professional, you should be aware of the important differences in reporting, as the consensus statement can allow for variability between manufacturers. can only be effectively used to compare implants when data is provided by all manufacturers following the same reporting principles. With this you can effectively counsel recipients and cochlear implant candidates. All cochlear implant manufacturers have different approaches to the evaluation of explanted devices. Advanced Bionics performs an exhaustive analysis on all returned devices including the assessment of device hermeticity. In the instance that a reported symptom cannot be confirmed or replicated, we have a cross-functional team of engineers who review the case and specify additional testing or analysis to determine the root cause. In order to maintain transparency, we record the results of all tests and rationale for any testing not performed in the analysis report. Advanced Bionics records all results even if unrelated to the final root cause. Please note that this level of documentation is required by the new U.S. cochlear implant standard, AAMI CI/Ed., Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting. Graph title shows the implant name and any additional identifying information. values are plotted with a marker for each year., children, and the combined data are plotted separately. Have Questions? Need More Information? Contact Us. AB steadfastly supports hearing healthcare professionals in their evaluation of clinical benefit provided by a device. Company representatives remain readily available for questions, troubleshooting assistance, and device testing for both recipients and professionals. Contact AB by calling.., ing hear@advancedbionics.com, or visiting AdvancedBionics.com. HiRes 0K Vendor A Post Mod..00%.00%.00%.00%.00%.00%.00%.00%.%.%.0%.%.%.%.%.%.0%.%.0%.0% What does mean? Cumulative survival rate () shows the percentage of implants that are still functional after the time in years indicated in the table and on the graph. You may also see this described as Cumulative Survival Percentage..%.%.% The black bars on each data point are confidence intervals. These are displayed to indicate the accuracy of statistical calculations..%.%.%.%.0%.%.%.0%.%.%.%.% 0.%.%.%.0%.0%.%.%.% Detailed percentages are shown for each year in the table. Results are broken up into adults, children, and shown as a combined total. Did you know that 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 implant users. Valerie S., AB Recipient

4 0 Global Implant Reliability Report 0 Global Implant Reliability Report HiRes Ultra Cochlear Implant The Industry s Newest Implant The HiRes Ultra offers a thin, discreet design suitable for adults and children alike. It is compatible with a T MRI procedure and it is designed to exceed the industry standards for impact resistance, offering peace of mind whilst enjoying life s adventures. The HiRes Ultra implant is the newest member of the HiRes implant family and features advanced sound processing circuitry to provide unsurpassed programming flexibility, nearly unlimited ways to deliver sound and full upgradeability for access to tomorrow s innovations without surgery. The thinner profile of the HiRes Ultra implant makes it suitable for all ages, while providing the highest rated resistance to impact trauma in the industry. And the improved MRI compatibility allows for state of the art medical care. The new HiRes Ultra implant has not yet been available in the market for the requisite time period to provide the -year data but we are happy to provide the -month data to demonstrate the initial quality and reliability of the device. To date we have 00% for the HiRes Ultra implant. Number of registered HiRes Ultra cochlear implants as of July, 0,,0 Date of first commercial introduction: 0 Cole S., AB Recipient

5 0 Global Implant Reliability Report 0 Global Implant Reliability Report Previous-Generation Implant Data HiRes 0K Advantage Cochlear Implant The HiRes 0K Advantage implant features the same advanced sound processing circuitry as the HiRes Ultra implant but offers the ability to create a greater depth bone bed for securing the implant. It also provides a choice of available electrode options. It has mechanical improvements over the HiRes 0K implant. Did you know that AB offers options for you to keep both of your ears working together and contributing to your hearing experience? The Naída CI sound processor works together with another Naída CI sound processor, a hearing aid or a wireless CROS microphone. HiRes 0K Cochlear Implant The HiRes 0K implant, the precursor to the HiRes 0K Advantage implant, has had some variants during its production. The variant currently available is termed the HiRes 0K (Vendor A Post-Mod) implant and benefits from some manufacturing modifications. Number of registered HiRes 0K Advantage implants as of July, 0,,,* Date of first commercial introduction: 0 Number of registered HiRes 0K (Vendor A Post Mod) implants as of July, 0,00,,* Last year of distribution : Still available in select markets HiRes 0K Advantage % HiRes 0K Vendor A Post Mod.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.%.%.%.0%.%.%.%.%.%.%.%.0%.00%.00%.%.%.0%.%.%.%.%.%.0%.%.0%.0%.%.%.%.%.%.%.0%.%.%.%.0%.%.%.%.% 0.%.%.%.0%.0%.%.%.%

6 0 Global Implant Reliability Report 0 Global Implant Reliability Report HiRes 0K Vendor A All % HiRes 0K Vendor A Pre Mod % Number of registered HiRes 0K (Vendor A All) implants as of July, 0,,,* Last year of distribution : Still available in select markets Number of registered HiRes 0K (Vendor A Pre Mod) implants as of July, 0,,0,* Last year of distribution : Still available in select markets HiRes 0K Vendor A Pre Mod HiRes 0K Vendor A - All %.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.00%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.0%.0%.%.%.%.%.0%.0%.%.%.0% 0.%.%.%.%.%.%.%.%.%.%.%.%.00%.%.%.%.%.0%.%.0%.%.%.%.%.%.%.%.%.%.%.0%.0%.0%.0%.%.%.%.%.%.% 0.%.%.%.0%.%.%.%.0%.%.%.0%.% Edward F., AB Recipient Aria S., AB Recipient 0

7 0 Global Implant Reliability Report 0 Global Implant Reliability Report HiRes 0K Vendor B % Number of registered HiRes 0K (Vendor B) implants as of July, 0,,,0* Last year of distribution : 00 (Implant Voluntarily Recalled in 00) 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 C. implants. Number of registered CII implants - July, 0,,0,0* HiRes 0K % Vendor B Last year of distribution : 00 Clarion CII % 0.00%.00% 0.00% (CII) 0.00% 0.00%.%.%.%.%.% 0.%.0%.0%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.% 0.%.%.% 0.%.0%.%.%.0% 0.%.0%.0% 0.%.%.0%.%.00% (CII) (CII) (CII) (CII) (CII).%.%.%.0%.%.%.0%.0%.%.%.%.0%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.% 0.%.%.%.%.%.%.%.%.%.0%.%.%.0%.%.%.00%.%.%.%.%.% Aisha S., AB Recipient Choosing a device commits you to a lifetime with that technology it is important that you choose a system capable of distinguishing between a drum and a flute, a high note and a low note, and the voice of a friend from that of a stranger. Kerun B., AB Recipient

8 0 Global Implant Reliability Report 0 Global Implant Reliability Report Clarion. (C.) Implant Number of registered C. implants - July, 0,0,,* Last year of distribution : 00 Clarion.0 (C.0) Implant The C.0 is Advanced Bionics first device, offering innovations such as independent current sources and pre-curved electrodes. As the number of children implant is below the level required for statistical analysis, the data is included with the adult data and presented as a combined. The low total population also requires the confidence intervals to be set to 0% for this group. Number of registered C.0 implants - July, 0 0 * Clarion C. % Last year of distribution : % Clarion C.0 %.00%.00% (C.) (C.) (C.) 0.00%.00%.00% 0.00%.00% (C.0).00% (C.0) 0.00% (C.) (C.) (C.).%.%.00%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.%.0%.%.%.0%.0%.% 0.%.%.%.%.0%.% 0.%.0%.% 0.%.% 0.% 0.%.% 0.%.%.%.%.%.%.0%.%.%.0%.%.%.%.%.%.% 0.%.%.%.%.%.%.00% 0.00%.00% 0.00% (C.0) (C.0).%.0%.%.%.%.%.%.%.%.0%.0%.%.0%.%.%.%.%.% 0.%.% 0.% 0.% 0.% 0.% 0.%.0%.%.0%.0%.%.0%.%.0%.%.0%.%.0%.% 0.0%.0%.%.%.%.% Poppy K., AB Recipient Llyod X., AB Recipient