Reliability

Outstanding Reliability Data

Outstanding Reliability Data

Average Monthly Service Rate
for MAESTRO CI System Audio Processors

To monitor the reliability of our audio processors, we calculate the “Monthly Service Rate (MSR).”¹ This number reflects the percentage of devices in the field which are returned for service. MED-EL has taken the industry lead in reporting reliability of external parts.

Average Monthly Service Rate

Reliability as measured in CSR

Our data is prepared in full accordance with ISO 5841-2:2000² and based on European and American consensus discussions between industry, medical professionals, and regulatory agencies.

We evaluate reliability using a special statistic called the Cumulative Survival Rate (CSR). The CSR statistic is the same one that is used to evaluate pacemaker reliability. MED-EL follows the reporting procedure in accordance with ISO 5841-2:2000². The CSR reporting method allows you to visualize how reliable our devices are over time.

CSR for the MED-EL CONCERT 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

Reliability of the PULSAR 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

Hagen et. al.: “An Innovative Approach for Reporting on Device Reliability”,APSCI 2007, Sydney
ISO 5841-2:2000: Implants for surgery – Cardiac Pacemakers – Part 2: Reporting of clinical performance of populations of pulse generators or leads

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