1. The combined failure rate was calculated for Advanced Bionics and Cochlear by estimating the number of failed devices from their publicly accessible reliability reports (Advanced Bionics 2017 Global Implant Reliability Report; Cochlear Nucleus Implant Reliability Report, Volume 15 / January 2017) and comparing those to the total number of registered implants; in the case of Cochlear, the Nucleus CI24RE, Nucleus CI500 series and the Nucleus Profile series implants were included in the calculations, covering the time period of 2005 to 2017; for Advanced Bionics, the calculations are based on the HiRes 90K, HiRes 90K Advantage and HiRes Ultra cochlear implants, covering the time period of 2004 to 2017. Please note, that Advanced Bionics and Cochlear only report a self-selected sub-category of failures, so the numbers presented may underestimate the total failure rates for Advanced Bionics HiRes implants and Cochlear Nucleus implants.
The combined rate for MED-EL implants was calculated using the information on device-related failures from the MED-EL complaint database for the SONATA, CONCERTO and SYNCHRONY implants, covering a time-frame of 11 years (2006–July 2017); this database is used as a tool for monitoring of all products that are put on the market, and its validity is regularly inspected by authorities, such as the FDA.
2. FDA Medical Device Recall Database
3. Kim, B.G., Kim, J.W., Park, J.J., Kim, S.H., Kim, H.N., & Choi, J.Y. (2015). Adverse events and discomfort during magnetic resonance imaging in cochlear implant recipients. JAMA Otolaryngol Head Neck Surg. 141(1), 45–52. doi: 10.1001/jamaoto.2014.2926. http://archotol.jamanetwork.com/article.aspx?articleid=1936465
These figures represent the percentage of recipients in the study who experienced discomfort, pain, or other complications during 1.5 T MRI (two 3.0 T scans were excluded from the figure). Kim et al. (2015) is a retrospective study looking at 1.5 T and 3.0 T MRI scans performed on CI recipients between 2003 and 2014. The study included 18 individuals; 5 recipients had Advanced Bionics devices, 11 had Cochlear devices, and 3 had MED-EL implants. Advanced Bionics recipients had 9 total 1.5 T scans; Cochlear recipients had 12 total 1.5 T scans and 2 total 3.0 T scans; and MED-EL recipients had 8 total 1.5 T scans.
4. Todt, I. Tittel, A., Ernst, A., Mittmann, P., & Mutze, S. (2017) Pain Free 3 T MRI scans in cochlear implantees. Otology & Neurotology, Epub ahead of print.
5. Recipients with a SYNCHRONY Cochlear Implant may be safely MRI scanned at 0.2, 1.0, 1.5, and 3.0 Tesla following the conditions detailed in the instructions for use.
6. Audio processor reliability rate is shown as the inverse of monthly service rate.