TY - JOUR
T1 - The reliability of hearing implants
T2 - report on the type and incidence of cochlear implant failures
AU - Van de Heyning, Paul
AU - Atlas, Marcus
AU - Baumgartner, Wolf Dieter
AU - Caversaccio, Marco
AU - Gavilan, Javier
AU - Godey, Benoit
AU - Gstöttner, Wolfgang
AU - Hagen, Rudolph
AU - Yongxin, Li
AU - Karltorp, Eva
AU - Kameswaran, Mohan
AU - Kuzovkov, Vlad
AU - Lassaletta, Luis
AU - Manoj, Manikoth
AU - Parnes, Lorne
AU - Pillsbury, Harold
AU - Raine, Christopher
AU - Rajan, Gunesh
AU - Schmutzhard, Joachim
AU - Skarzynski, Henryk
AU - Staecker, Hinrich
AU - Usami, Shin ichi
AU - Zernotti, Mario
PY - 2020/7/3
Y1 - 2020/7/3
N2 - Objectives: This study presents the data collected through a database on the type and incidence of cochlear implant device failures and major complications and quantifies the risk of failures across time based on the Association for the Advancement of Medical Instrumentation (AAMI) CI86:2017 standard. Methods: Information on reliability of MED-EL cochlear implants was collected from the MED-EL complaint database between 2003 and2013. Explants were categorized and device reliability was calculated according to the AAMI CI86:2017 standard principles. Results: Data were collected for 11662 devices (5462 children, 6200 adults). The mean duration of follow up was 46.16 months. The total failure rate for all devices and all subjects was 2.41%. Medical related explants (MRE) were significantly worse for children than for adults with the ceramic implants, C40+ (p = 0.008) and PULSAR (p = 0.020). Device failure explants (DFE) were significantly worse for children than for adults with all four devices in the study, the C40+ (p < 0.001), PULSAR (p < 0.001), SONATA (p < 0.001), and CONCERTO (p = 0.023). The mean annual failure rate for all subjects and devices was 0.63% (1.03% for children, 0.28% for adults). The mean annual failure rate was 0.90% for the C40+; 0.57% for the PULSAR; 0.46% for the SONATA; and 0.39% for the CONCERTO. Conclusions: Compared to adults, children had significantly worse MRE and DFE due to a higher risk of head trauma and more vulnerable skull anatomy. Further, the authors conclude that the AAMI standard will ensure a more comprehensive and transparent evaluation of cochlear implant reliability in the future.
AB - Objectives: This study presents the data collected through a database on the type and incidence of cochlear implant device failures and major complications and quantifies the risk of failures across time based on the Association for the Advancement of Medical Instrumentation (AAMI) CI86:2017 standard. Methods: Information on reliability of MED-EL cochlear implants was collected from the MED-EL complaint database between 2003 and2013. Explants were categorized and device reliability was calculated according to the AAMI CI86:2017 standard principles. Results: Data were collected for 11662 devices (5462 children, 6200 adults). The mean duration of follow up was 46.16 months. The total failure rate for all devices and all subjects was 2.41%. Medical related explants (MRE) were significantly worse for children than for adults with the ceramic implants, C40+ (p = 0.008) and PULSAR (p = 0.020). Device failure explants (DFE) were significantly worse for children than for adults with all four devices in the study, the C40+ (p < 0.001), PULSAR (p < 0.001), SONATA (p < 0.001), and CONCERTO (p = 0.023). The mean annual failure rate for all subjects and devices was 0.63% (1.03% for children, 0.28% for adults). The mean annual failure rate was 0.90% for the C40+; 0.57% for the PULSAR; 0.46% for the SONATA; and 0.39% for the CONCERTO. Conclusions: Compared to adults, children had significantly worse MRE and DFE due to a higher risk of head trauma and more vulnerable skull anatomy. Further, the authors conclude that the AAMI standard will ensure a more comprehensive and transparent evaluation of cochlear implant reliability in the future.
KW - Adults
KW - Children
KW - Cochlear Implant
KW - Device failure
KW - Explant
KW - Failure analysis
UR - http://www.scopus.com/inward/record.url?scp=85081331607&partnerID=8YFLogxK
U2 - 10.1080/14670100.2020.1735678
DO - 10.1080/14670100.2020.1735678
M3 - Article
C2 - 32156201
AN - SCOPUS:85081331607
SN - 1467-0100
VL - 21
SP - 228
EP - 237
JO - Cochlear Implants International
JF - Cochlear Implants International
IS - 4
ER -