Liliane L. Tessa, Bhanu P. Sood and Michael G. Pecht.
Center for Advanced Life Cycle Engineering (CALCE), University of Maryland, College Park, MD 20740, USA
Cochlear implants are electronic devices used to provide
useful hearing sensations to patients with severe to profound
hearing loss. Safety and reliability are considered by patients and
clinicians when selecting among the different models of cochlear
implants. However, comparing reliability estimates from different
manufacturers is difficult because of the lack of a standardized
approach for classifying and quantifying failure data. This paper
develops a classification scheme for cochlear implant failures
wherein each failure report is categorized based on the failure
site, cause, mode, and mechanism obtained through failure modes,
mechanisms, and effects analysis. Failure parameters based on the
Weibull distribution are used to quantify the following reliability
metrics: B1 , B5 , B10, and B50 lives. The developed reporting
scheme provides clear and quantitative information on failure
causes and failure sites for a given implant. This method provides
a consistent reporting format for communicating field reliability to
regulatory units, clinicians, and patients.
Keywords: Cochlear implants, field failures, reliability.
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