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Performing Repeated Intraoperative Impedance Telemetry Measurements during Cochlear Implantation
Published on: August 4, 2023
International classification of reliability for implanted cochlear implant receiver stimulators
Rolf-Dieter Battmer1, Douglas D Backous, Thomas J Balkany
1Center for Clinical Technology Research, Berlin, Germany.
Summary
A new international standard for reporting cochlear implant (CI) reliability has been developed. This standard aims to ensure consistent and comprehensive reporting of implanted device performance across manufacturers and research publications.
Area of Science:
- Medical Devices
- Biomedical Engineering
- Clinical Trials
Background:
- Cochlear implant (CI) systems require standardized reliability reporting for regulatory bodies, clinical centers, and research evaluation.
- Existing efforts in CI reliability reporting lacked consistency across international manufacturers.
Framework:
- An International Consensus Group developed a standardized classification system for implanted CI components.
- The framework is adapted from ISO standard 5841-2:2000, originally for cardiac pacemaker reliability.
Implementation:
- Standardized definitions for device failure, survival time, and clinical benefit were established.
- Agreed-upon protocols for reporting out-of-specification devices, explanted device categorization, and cumulative survival calculations were created.
Implications:
- The new standard promotes consistent and transparent reporting of CI device reliability.
- Adoption of this standard is recommended for CI manufacturers and journal editors to enhance research quality and regulatory oversight.
