Field Reliability Estimation for Cochlear Implants

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.

[1]  Karen M Mispagel,et al.  Factors Affecting Open-Set Word Recognition in Adults With Cochlear Implants , 2013, Ear and hearing.

[2]  Michael G. Pecht,et al.  Using Failure Modes, Mechanisms, and Effects Analysis in Medical Device Adverse Event Investigations , 2011, ICBO.

[3]  T. Lenarz,et al.  International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators , 2010, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[4]  T. Lenarz,et al.  A Review of Device Failure in More Than 23 Years of Clinical Experience of a Cochlear Implant Program With More Than 3,400 Implantees , 2009, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[5]  Michael Pecht,et al.  Physics-of-failure-based prognostics for electronic products , 2009 .

[6]  J. Piron,et al.  Reliability and complications of 500 consecutive cochlear implantations. , 2008, Archives of otolaryngology--head & neck surgery.

[7]  Blake S Wilson,et al.  Cochlear implants: current designs and future possibilities. , 2008, Journal of rehabilitation research and development.

[8]  Fan-Gang Zeng,et al.  Cochlear Implants: System Design, Integration, and Evaluation , 2008, IEEE Reviews in Biomedical Engineering.

[9]  Blake S. Wilson,et al.  The Surprising Performance of Present-Day Cochlear Implants , 2007, IEEE Transactions on Biomedical Engineering.

[10]  F. Telischi,et al.  Cochlear Implant Soft Failures Consensus Development Conference Statement , 2005, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[11]  J. Maurer,et al.  Reliability of cochlear implants , 2005, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[12]  H. Pillsbury,et al.  Revision Cochlear Implant Surgery in Adult Patients with Suspected Device Malfunction , 2004, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[13]  Robert V. Brill,et al.  Applied Statistics and Probability for Engineers , 2004, Technometrics.

[14]  R. Fechter,et al.  Failure Mode Effect Analysis Applied to the Use of Infusion Pumps , 2004, The 26th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[15]  S. Mukherji,et al.  Cochlear implant failure: imaging evaluation of the electrode course. , 2003, Clinical radiology.

[16]  David Olwell,et al.  Reliability Engineering and Risk Analysis , 2001, Technometrics.

[17]  Martin Newby.  Why no additive hazards models , 1994 .