VALIDATION OF A BILATERAL SIMULTANEOUS COMPUTER-BASED TYMPANOMETER

This study investigated the reliability and accuracy of unilateral and bilateral simultaneous tympanometric measurements of the Kuduwave Pro-TMP audiometer with integrated tympanometer. This was done by comparing tympanometric measurements yielded with the Kuduwave Pro-TMP in its unilateral and bilateral simultaneous condition with an industry-standard tympanometer. A within-subject repeated measures design was utilised in this study.

No significant bias (p>.05) was observed between the mean differences of tympanometric measures obtained by the Kuduwave Pro-TMP audiometer and the industry-standard tympanometer, except for a significant bias (p<.05) of the mean difference for ear canal volume measurements (0.05 cm3).

The Bland-Altman plots showed overall good agreement between the tympanometric measurements between the two instruments. When comparing tympanogram types yielded by the Kuduwave Pro-TMP and those of the industry-standard tympanometer, the results were highly comparable with a sensitivity and specificity of 100% (95% CI [86.8%, 100%]) and 92.3% (95% CI [84.0%, 97.1%]), respectively.

This study confirmed that the investigational device is a reliable and valid tool for tympanometric measurements in its unilateral and bilateral simultaneous condition.