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Related Experiment Video

Updated: Jul 15, 2026

Performing Repeated Intraoperative Impedance Telemetry Measurements during Cochlear Implantation
06:54

Performing Repeated Intraoperative Impedance Telemetry Measurements during Cochlear Implantation

Published on: August 4, 2023

Standardization of reliability reporting for cochlear implants: an interim report.

Douglas D Backous1, Stacey D Watson

  • 1The Listen for Life Center at Virginia Mason, Section of Otolaryngology-Head and Neck Surgery, Virginia Mason Medical Center Seattle, Seattle, Washington 98111-0900, USA. otoddb@vmmc.org

Ear and Hearing
|May 15, 2007
PubMed
Summary

A new standard defines "out of specification" for cochlear implants, ensuring fair reporting of device reliability and cumulative survival statistics. This improves patient care and allows for better comparison between manufacturers.

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Area of Science:

  • Biomedical Engineering
  • Medical Device Reliability
  • Otolaryngology

Background:

  • Current cochlear implant reliability reporting lacks standardization, hindering fair comparisons between manufacturers and obscuring trends in device performance.
  • A consistent definition of
  • out of specification
  • is needed to accurately assess cumulative survival statistics.

Framework:

  • Propose a standard definition for
  • out of specification
  • cochlear implants.
  • Incorporate Category C (ISO 5841-2:2000) into cumulative survival reporting.
  • Establish reporting guidelines including separate data for children and adults, annual reporting per device model, and a minimum of 200 devices per model group for Cumulative Survival Reporting (CSR).

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Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
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Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages

Published on: March 24, 2023

Related Experiment Videos

Last Updated: Jul 15, 2026

Performing Repeated Intraoperative Impedance Telemetry Measurements during Cochlear Implantation
06:54

Performing Repeated Intraoperative Impedance Telemetry Measurements during Cochlear Implantation

Published on: August 4, 2023

Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
06:04

Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages

Published on: March 24, 2023

Implementation:

  • Engaged cochlear implant manufacturers in a collaborative, iterative process over 13 months.
  • Presented findings and gathered feedback from clinicians and industry representatives at multiple conferences.
  • Developed a complaint-driven standard with clear definitions for explantation categories (biological, technical, under investigation) and reporting timelines.

Implications:

  • Enhances patient care by providing understandable and reliable data to clinicians.
  • Fosters equitable and accurate reporting, preventing bias towards any single manufacturer.
  • Establishes a foundation for future research involving cochlear implant device reliability in medical literature.