Standardy používané firmou MED-EL při hlášení spolehlivosti výrazně překračují zpravodajské metody používané konkurenty. Údaje o spolehlivost kochleárních implantátů MED-EL jsou zpracovány v souladu s normou ISO 5841-2:2000, kterou se řídí i vykazování spolehlivosti kardiostimulátorů 1). MED-EL současně informuje o spolehlivosti vnitřní (implantát) i vnější (řečový procesor) části implantátu.
Údaj ke sledování spolehlivosti implantátů v čase se nazývá "CMR Cumulative Survival Rate", v překladu "souhrná míra přežití". Tento údaj je podrobně popsán ve výše jmenované normě 1). Číslo v % udává pravděpodobnost, kolik kochleárních implantátů stále plní svoji zamýšlenou funkci pro dané časové období od začátku výroby hodnoceného typu.
Při srovnávání spolehlivosti produktů všech výrobců je nutné mít na zřeteli následující:
- Srovnávat přibližně stejný počet přístrojů
- Zpracovat stejné časové období
- Porovnat podobnou generaci přístrojů
- A mít k dispozici kompletní data
MED-EL standardně uvádí i aktuální data o závadovosti svých audioprocesor.
Údaje o spolehlivosti jsou průběžně aktualizovány na internetových stránkách výrobce.
Odkazy na studie:
[1] - Advanced Bionics AG and affiliates. (2022). Advanced Bionics Reliability Report December 2022, 028-Q048-02 Rev B.
[2] - Cochlear Ltd. (2021). Cochlear Nucleus System Reliability Report, Volume 20, December 2021, D1932781 V1 2022-03.
[3] - MED-EL. (2023). MED-EL Cochlear Implant Systems Reliability Report April 2023. All registered and currently marketed implants are included in the reliability calculations, and every explanted and returned implant is subject to systematic failure analysis. All failures are classified and Cumulative Survival Rates (CSR) are calculated in accordance with ISO 5841-2:2014. All confirmed device malfunctions including accident-related failures are considered for reporting. Failures traced back to induced malfunctions are not included in the reported data in compliance with the ISO standard. The results of the calculations are reported following principles of the European Consensus on Cochlear Implant Failures and Explantations, with adults and children being shown separately and with 95% confidence intervals. Please be aware that confidence intervals smaller than 0.1% may not be clearly visible in the graphs. The sample size of each model and population are not provided. MED-EL publishes reliability data one year after the first implantation at the earliest.
[4] - International Standard ISO 5841-2:2014. (2014). Implants for Surgery — Cardiac Pacemakers — Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads. Geneva (Switzerland): International Organization for Standardization.
[5] - European Consensus Statement on Cochlear Implant Failures and Explantations. (2005). Otology & Neurotology, 26(6), 1097-1099. doi: 10.1097/01. mao.0000194885.51647.bb
[6] - Suhling, M., Majdani, O., Salcher, R., Leifholz, M., Büchner, A., Lesinski-Schiedat, A., & Lenarz, T. (2016). The Impact of Electrode Array Length on Hearing Preservation in Cochlear Implantation. Otology & Neurotology, 37(8), 1006-1015. doi: 10.1097/mao.0000000000001110
[7] - Helbig, S., Adel, Y., Rader, T., Stoever, T., & Baumann, U. (2016). Long-term hearing preservation outcomes after cochlear implantation for electricacoustic stimulation. Otol Neurotol. 37(9).
[8] - O’Connell, B., Hunter, J., Haynes, D., Holder, J., Dedmon, M., & Noble, J. et al. (2017). Insertion depth impacts speech perception and hearing preservation for lateral wall electrodes. The Laryngoscope, 127(10), 2352-2357. doi:12.1002/lary.26467
[9] - Manjaly, J., Nash, R., Ellis, W., Britz, A., Lavy, J., & Shaida, A. et al. (2018). Hearing Preservation With Standard Length Electrodes in Pediatric Cochlear Implantation. Otology & Neurotology, 39(9), 1109-1114. doi: 10.1097/mao.0000000000001917
[10] - Skarzynski, P., Skarzynski, H., Dziendziel, B., Rajchel, J., Gos, E., & Lorens, A. (2019). Hearing Preservation With the Use of Flex20 and Flex24 Electrodes in Patients With Partial Deafness. Otology & Neurotology, 40(9), 1153-1159. doi:10.1097/mao.0000000000002357
[11] - Yoshimura, H., Moteki, H., Nishio, S., Miyajima, H., Miyagawa, M., & Usami, S. (2020). Genetic testing has the potential to impact hearing preservation following cochlear implantation. Acta Oto-Laryngologica, 140(6), 438-444. doi: 10.1080/00016489.2020.1730439
[12] - Sprinzl, G., Schoerg, P., Edlinger, S., & Magele, A. (2020). Long-term Hearing Preservation in Electric Acoustic Cochlear Implant Candidates. Otology & Neurotology, 41(6), 750-757. doi: 10.1097/mao.0000000000002627
[13] - Literature Search Report (2020). Data on File, MED-EL
[14] - Tykocinski, M., Shepherd, R.K., & Clark, G. (1995). Electrophysiologic effects following acute intracochlear direct current stimulation of the guinea pig cochlea. Ann Otol Rhinol Laryngol (166): 68–71.
[15] - Huang, C., Carter, P., & Shepherd, R. (2001). Stimulus Induced pH Changes in Cochlear Implants: An In Vitro and In Vivo Study. Annals Of Biomedical Engineering, 29(9), 791-802. doi: 10.1114/1.1397793
[16] - Huang, C., Shepherd, R., Seligman, P., & Clark, G. (1998). Reduction in excitability of the auditory nerve following acute electrical stimulation at high stimulus rates: III. Capacitive versus non-capacitive coupling of the stimulating electrodes. Hearing Research, 116(1-2), 55-64. doi: 10.1016/ s0378-5955(97)00196-2
[17] - Clark, G. (2003). Cochlear Implants: Fundamentals and Applications. New York: Springer.
[18] - 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.
[19] - 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.
[20] - The Monthly Repair Rate is a percentage that indicates the total number of audio processors returned in a month compared to the total number sold by the end of that month.