MED-EL Cochlear Implants    Speech Processors    Accessories

Raising the Bar on Reliability

At MED-EL, providing the highest quality and having the most reliable products is our first and foremost priority. To ensure that current and prospective MED-EL users and the community of professionals are fully informed, MED-EL regularly publishes detailed up-to-date information on the reliability of its cochlear implants.

How is reliability measured?

In order to measure the reliability of cochlear implants in an objective way the Cumulative Survival Rate (CSR) is calculated.

The CSR indicates the percentage of implants still fully functioning after a certain period of time. MED-EL is the only manufacturer that publishes not only traditional CSR-data according to the ISO 5841-2:2000 standard, but also provides additional detail that we call the Extended CSR . Extended CSR data assures full transparency relative to the various causes of device malfunction.

Extended Cumulative Survival Rate

The CSR is being calculated in full accordance with ISO 5841- 2:2000 and includes:

  • Device related Cumulative Survival Rate including accident related root causes for malfunction
  • Device related Cumulative Survival Rate excluding accident related root causes for malfunction
  • Extended CSR including medical, surgical as well as accident related issues

MED-EL’s Implant CSR Data:

  • Comply with the ISO 5841-2: 2000
  • Are based on the categorization of failure modes of implanted devices according to the available complaint reports or according to the results of the technical investigation of explanted systems
  • Include all categories of device malfunction including accident related causes
  • Are in keeping with the results of the European and American consensus discussions
  • Consider devices in populations of at least 200 for any given time frame

Since the first implantation of the PULSARCI100 in March of 2004, not a single implant has failed due to loss of hermeticity or electronic defect. The same holds true for the optimized C40+ implants manufactured since May 2002.

Experience over the last 4 years shows an accident related failure rate of the hermetic housing of 0.14% per year. This value is in the range of the US wide rate of accident related traumatic brain injury**

0.1% … children between 0 and 4 years
2.87% … for adults

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Since the first implantation in June 2006 not a single SONATATI100 cochlear implant had to be re-implated for device related, surgical or medical reasons. This also holds true for accident related issues.

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Reliability data for the COMBI 40+

 
 

© 2008 Medical Electronics