PULSARCI100 Cochlear Implant Cumulative Survival Rate
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 so-called Cumulative Survival Rate (CSR) is calculated.
The latter 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. Additionally, in order to assure full transparency relative to the various causes of device malfunction, MED-EL also publishes "Extended CSR" data.
Extended “Cumulative Survival Rate”
The CSR is being calculated in full accordance with ISO 5841- 2:2000 for cardiac pacemakers and includes all device-related, medical and surgical roots causes for malfunction of the implant. Of course, accident related causes of defects are also included.
The following classification aims at a higher level of transparency:
How is reliability measured?
In order to measure the reliability of cochlear implants in an objective way the so-called Cumulative Survival Rate (CSR) is calculated.
The latter 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. Additionally, in order to assure full transparency relative to the various causes of device malfunction, MED-EL also publishes "Extended CSR" data.
Extended “Cumulative Survival Rate”
The CSR is being calculated in full accordance with ISO 5841- 2:2000 for cardiac pacemakers and includes all device-related, medical and surgical roots causes for malfunction of the implant. Of course, accident related causes of defects are also included.
The following classification aims at a higher level of transparency:
- “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
- comply with the ISO 5841-2: 2000 for cardiac pacemakers
- 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 defects. For the modified C40+ implants in use since May 2002, not a single implant has failed due to loss of hermeticity.
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 **
** 1.0% … children between 0 and 4 years
2.8% … for adults
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