Assessing the accuracy of tympanometric evaluation of external auditory canal volume: a scientific study using an ear canal model.

Tympanometric evaluation is routinely used as part of the complete otological examination. During tympanometric examination, evaluation of middle ear pressure and ear canal volume is undertaken. Little is reported in relation to the accuracy and precision tympanometry evaluates external ear canal volume. This study examines the capability of the tympanometer to accurately evaluate external auditory canal volume in both simple and partially obstructed ear canal models and assesses its capability to be used in studies examining the effectiveness of cerumolytics. An ear canal model was designed using simple laboratory equipment, including a 5 ml calibrated clinical syringe (Becton Dickinson, Spain). The ear canal model was attached to the sensing probe of a Kamplex tympanometer (Interacoustics, Denmark). Three basic trials were undertaken: evaluation of the tympanometer in simple canal volume measurement, evaluation of the tympanometer in assessing canal volume with partial canal occlusion at different positions within the model, and evaluation of the tympanometer in assessing canal volume with varying degrees of canal occlusion. 1,290 individual test scenarios were completed over the three arms of the study. At volumes of 1.4 cm(3) or below, a perfect relationship was noted between the actual and tympanometric volumes in the simple model (Spearman's ρ = 1) with weakening degrees of agreement with increasing volume of the canal. Bland-Altman plotting confirmed the accuracy of this agreement. In the wax substitute models, tympanometry was observed to have a close relationship (Spearman's ρ > 0.99) with the actual volume present with worsening error above a volume of 1.4 cm(3). Bland-Altman plotting and precision calculations provided evidence of accuracy. Size and position of the wax substitute had no statistical effect on results [Wilcoxon rank-sum test (WRST) p > 0.99], nor did degree of partial obstruction (WRST p > 0.99). The Kamplex tympanometer accurately and precisely assesses ear canal volume in the scientific model in both simple and partially occluded wax substitute scenarios up to a volume of 1.4 cm(3). These findings suggest that the Kamplex tympanometer could be used as an effective objective tool in evaluating the efficacy of topical cerumolytics in both laboratory and human models.