Outstanding Reliability Data

Average Monthly Service Rate for Audio Processor Control Units

To monitor the reliability of our audio processors and other external components, we calculate the “Average Monthly Service Rate (AMSR)”. This number reflects the average percentage of devices that are returned to MED-EL for service each month and that are found to be defective.

The data reflect MED-EL’s continuing commitment to enhancing reliability with each new product generation.

Average Monthly Service Rate

Cumulative Survival Rate (CSR)
of MAESTRO CI System Implants

The metric used to monitor the reliability of implants over time is called the Cumulative Survival Rate. The Cumulative Survival Rate, as described in detail in the international standard ISO 5841-2:20002, indicates the probability that an implant fulfills its intended function for a given time period. For each time period, we report three different values:

  • the Extended CSR, the “real” cumulative survival rate, which incorporates all explanted devices independent of the root cause of failure (device related failures, accident related failures, medical and surgical failures), and
  • two Device CSRs
    • one considering all device related and accident related root causes for malfunction of the implant, as requested by the Global Consensus Statement on Cochlear Implant Failures and Explantations, and
    • the other considering device related failures that were not related to an accident, for direct evaluation of the technology only.

Reliability of the CONCERTO Implant

Device related issues - without accident related issues
Device related plus accident related issues
Extended CSR data - device related plus medical, surgical and accident related issues

Reliability of the SONATA Implant

Device related issues - without accident related issues
Device related plus accident related issues
Extended CSR data - device related plus medical, surgical and accident related issues
  1. R.-D. Battmer, D. D. Backous, T. J. Balkany, et al. International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators. Otol Neurotol 31:1190-1193, 2010.
  2. ISO 5841-2:2000: Implants for surgery – Cardiac Pacemakers – Part 2: Reporting of clinical performance of populations of pulse generators or leads

© 2013 MED-EL