Journal article
International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators
Otology & neurotology, Vol.31(8), pp.1190-1193
10/2010
DOI: 10.1097/MAO.0b013e3181d2798e
PMCID: PMC4886654
PMID: 20864879
Abstract
Objective:
To design an international standard to be used when reporting reliability of the implanted components of cochlear implant systems to appropriate governmental authorities, cochlear implant (CI) centers, and for journal editors in evaluating manuscripts involving cochlear implant reliability.
Study Design:
The International Consensus Group for Cochlear Implant Reliability Reporting was assembled to unify ongoing efforts in the United States, Europe, Asia, and Australia to create a consistent and comprehensive classification system for the implanted components of CI systems across manufacturers.
Setting:
All members of the consensus group are from tertiary referral cochlear implant centers.
Interventions:
None.
Main Outcome Measure:
A clinically relevant classification scheme adapted from principles of ISO standard 5841-2:2000 (1) originally designed for reporting reliability of cardiac pacemakers, pulse generators, or leads.
Results:
Standard definitions for device failure, survival time, clinical benefit, reduced clinical benefit, and specification were generated. Time intervals for reporting back to implant centers for devices tested to be "out of specification," categorization of explanted devices, the method of cumulative survival reporting, and content of reliability reports to be issued by manufacturers was agreed upon by all members. The methodology for calculating Cumulative survival was adapted from ISO standard 5841-2:2000 (1).
Conclusion:
The International Consensus Group on Cochlear Implant Device Reliability Reporting recommends compliance to this new standard in reporting reliability of implanted CI components by all manufacturers of CIs and the adoption of this standard as a minimal reporting guideline for editors of journals publishing cochlear implant research results.
Details
- Title: Subtitle
- International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators
- Creators
- Rolf-Dieter Battmer - Center for Clinical Technology Research, Berlin, GermanyDouglas D Backous - The Listen for Life Center at Virginia Mason, Seattle, WashingtonThomas J Balkany - Department of Otolaryngology, University of Miami Ear Institute, Miami, Florida, U.S.ARobert J. S Briggs - Otology Unit, The Royal Victorian Eye and Ear Hospital, Melbourne, AustraliaBruce J Gantz - Department of Otolaryngology/Head & Neck Surgery, The University of Iowa, Iowa City, Iowa, U.S.AAndrew van Hasselt - Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong, ChinaChong Sun Kim - Department of Otolaryngology, Seoul National University Bundang Hospital, Seoul, KoreaTakeshi Kubo - Department of Otorhinolaryngology, Osaka University School of Medicine, Osaka, JapanThomas Lenarz - Department of Otolaryngology, Medical University Hannover, Hannover, GermanyHarold C Pillsbury - Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.AGerard M O’Donoghue - Department of Otolaryngology, University Hospital NHS Trust, Nottingham, U.KInternational Consensus Group for Cochlear Implant Reliability Reporting
- Resource Type
- Journal article
- Publication Details
- Otology & neurotology, Vol.31(8), pp.1190-1193
- DOI
- 10.1097/MAO.0b013e3181d2798e
- PMID
- 20864879
- PMCID
- PMC4886654
- NLM abbreviation
- Otol Neurotol
- ISSN
- 1531-7129
- eISSN
- 1537-4505
- Language
- English
- Date published
- 10/2010
- Academic Unit
- Neurosurgery; Otolaryngology
- Record Identifier
- 9984006438002771
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