SONATATI¹⁰⁰ 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 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 two kinds of Cumulative Survival Rates and thus, makes a previously unequalled level of transparency possible.

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.


Device related “Cumulative Survival Rate”
The CSR is also calculated in full accordance with ISO 5841- 2:2000 and includes all device related root causes for malfunction of the implant.

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

MED-EL’s Implant CSR Data

• comply with the ISO 5841-2: 2000 for cardiac pacemakers
• are based on the categorization 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 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.