Validation of a Bilateral Simultaneous Computer-Based Tympanometer

Purpose This study aimed to investigate the accuracy of bilateral simultaneous tympanometric measurements using a tympanometer with two pneumatic systems inside circumaural ear cups. Method Fifty-two adults (104 ears), with a mean age of 32 years (SD = 12.39, range: 18-60 years) were included in this study. A within-subject repeated-measures design was used to compare tympanometric measurements yielded with the investigational device in unilateral and bilateral simultaneous conditions compared with an industry-standard tympanometer. Results No significant bias (p > .05) was found between the mean of the differences of tympanometric measurements yielded by the two devices, except for a significant bias (p < .05) of the mean of the differences for ear canal volume measurements (0.05 cm³). The Bland-Altman plots showed overall good agreement between the tympanometric measurements between the two instruments. In all 104 ears, the tympanogram types of the KUDUwave TMP were compared with the reference device. 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. Conclusions The investigational device is a suitable instrument for unilateral or bilateral simultaneous tympanometric measurements in adults and demonstrates the potential of decentralized and accessible tympanometry services.