Validation of a Bilateral Simultaneous Computer-Based Tympanometer (Publication)

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

No significant bias (p>.05) was observed between the mean differences of tympanometric measures obtained by the KUDUwave TMP 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 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.

Read the full article here: American Journal of Audiology