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Improving Accuracy and Reliability of Hearing Tests: Measurement Standards for Audiometric Devices

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Pure-tone audiometry, using an audiometer, is the fundamental hearing test for diagnosing hearing loss. The requirements of the devices and the detailed process for calibrating the related equipment are described in international standards. However, traceable calibration and uncertainty evaluation processes are not widely accepted or applied to the qualification and maintenance of audiometric equipment. Here, we briefly review standard measurement systems for audiometric devices and introduce their calibration procedures. The uncertainty of each calibration process was investigated, and its impact on hearing test results was considered. Our findings show that the traceability of each procedure can be secured, satisfying the uncertainty requirement and being sufficiently smaller than the permissible deviation from the audiometer requirement. To guarantee the objectivity and reliability of hearing tests and maintain low uncertainty, close cooperation and mutual understanding between the metrology field and the medical community are necessary.

Abstract

Pure-tone audiometry, using an audiometer, is the fundamental hearing test for diagnosing hearing loss. The requirements of the devices and the detailed process for calibrating the related equipment are described in international standards. However, traceable calibration and uncertainty evaluation processes are not widely accepted or applied to the qualification and maintenance of audiometric equipment. Here, we briefly review standard measurement systems for audiometric devices and introduce their calibration procedures. The uncertainty of each calibration process was investigated, and its impact on hearing test results was considered. Our findings show that the traceability of each procedure can be secured, satisfying the uncertainty requirement and being sufficiently smaller than the permissible deviation from the audiometer requirement. To guarantee the objectivity and reliability of hearing tests and maintain low uncertainty, close cooperation and mutual understanding between the metrology field and the medical community are necessary.

참고문헌 (23)

  1. International Organization for Standardization, "Acoustics—audiometric test methods. Part 1: pure-tone air and bone conduction audiometry (ISO 8253-1:2010)", International Organization for Standardization, ~ (2010)
  2. Joint Committee for Guides in Metrology, "International vocabulary of metrology–basic and general concepts and associated terms (VIM)(JCGM 200:2012)" (2012), Bureau International des Poids et Mesures
  3. International Electrotechnical Commission, "Electroacoustics-audiometric equipment-part 1: equipment for pure-tone and speech audiometry (IEC 60645-1:2017)", International Electrotechnical Commission, ~ (2017)
  4. International Electrotechnical Commission, "Electroacoustics—simulators of human head and ear—part 1: ear simulator for the measurement of supra-aural and circumaural earphones (IEC 60318-1:2009)", International Electrotechnical Commission, ~ (2009)
  5. International Electrotechnical Commission, "Electroacoustics—simulators of human head and ear—part 4: occluded-ear simulator for the measurement of earphones coupled to the ear by means of ear inserts (IEC 60318-4:2010)", International Electrotechnical Commission, ~ (2010)
  6. International Electrotechnical Commission, "Electroacoustics—simulators of human head and ear—part 6: mechanical coupler for the measurement on bone vibrators (IEC 60318-6:2007)", International Electrotechnical Commission, ~ (2007)
  7. International Electrotechnical Commission, "Measurement microphones—part 1: specifications for laboratory standard microphones (IEC 61094-1:2000)", International Electrotechnical Commission, ~ (2000)
  8. International Electrotechnical Commission, "Electroacoustics—measurement microphones—part 2: primary method for pressure calibration of laboratory standard microphones by the reciprocity technique (IEC 61094-2:2009)", International Electrotechnical Commission, ~ (2009)
  9. International Electrotechnical Commission, "Measurement microphones—part 4: specifications for working standard microphones (IEC 61094-4:1995)", International Electrotechnical Commission, ~ (1995)
  10. International Electrotechnical Commission, "Electroacoustics—measurement microphones—part 5: methods for pressure calibration of working standard microphones by comparison (IEC 61094-5:2016)", International Electrotechnical Commission, ~ (2016)
  11. International Electrotechnical Commission, "Electroacoustics—sound level meters—part 1: specifications (IEC 61672-1:2013)", International Electrotechnical Commission, ~ (2013)
  12. International Organization for Standardization, "Methods for the calibration of vibration and shock transducers. Part 11: primary vibration calibration by laser interferometry (ISO 16063-11:1999)", International Organization for Standardization, ~ (1999)
  13. International Organization for Standardization, "Methods for the calibration of vibration and shock transducers. Part 21: vibration calibration by comparison to a reference transducer (ISO 16063-21:2003)", International Organization for Standardization, ~ (2003)
  14. Scott DA, "Traceable calibration of impedance heads and artificial mastoids", Meas Sci Technol, 26, pp.125013~ (2015)
  15. International Organization for Standardization, "Part 3: guide to the expression of uncertainty in measurement (GUM:1995) (ISO", IEC Guide 98-3:2008), 2008
  16. Cho WH, "Calibration and uncertainty evaluation of the devices for audiometry", INTER-NOISE and NOISE-CON Congress and Conference Proceedings, InterNoise20, pp.4093~4098 (2020), Institute of Noise Control Engineering
  17. Calibration of artificial mastoids and impedance transducers EUROMET project 401, "Rasmussen K", EUROMET, ~, pp.report PL-15 (2000)
  18. International Organization for Standardization, "Acoustics—reference zero for the calibration of audiometric equipment—part 1: reference equivalent threshold sound pressure levels for pure tones and supraaural earphones (ISO 389-1:2017)", International Organization for Standardization, ~ (2017)
  19. International Organization for Standardization, "Acoustics—reference zero for the calibration of audiometric equipment—part 3 : reference equivalent threshold vibratory force levels for pure tones and bone vibrators(ISO 389-3 : 2016)", International Organization for Standardization, ~ (2016)
  20. Cho WH, "Consideration on the uncertainty of audiometer calibration and pure tone audiometry", INTER-NOISE and NOISECON Congress and Conference Proceedings, InterNoise23, pp.5980~5986 (2023), Institute of Noise Control Engineering
  21. International Electrotechnical Commission, "Electroacoustics—methods to determine corrections to obtain the free-field response of a sound level meter(IEC 62585 : 2012)", International Electrotechnical Commission, ~ (2012)
  22. Suh MJ, "Improving accuracy and reliability of hearing tests : an exploration of international standards", J Audiol Otol, 27, pp.169~180 (2023)
  23. International Organization for Standardization, "General requirements for the competence of testing and calibration laboratories (ISO", IEC 17025:2017), 2017

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