Results of an Interventional Trial on the Safety and Effectiveness of an Automated Ear Cleaning System to Treat Cerumen Impactions

Authors
1 Matthew Thompson MD, MPH, DPhil
1 Bianca Frogner, PhD
2 Sunil K. Ummat, MD, MBA
3 Jeffrey Bower, PhD
3 Aadil Diwan

Affiliations
1 Department of Family Medicine, University of Washington, Seattle, WA, USA
2 Department of Otolaryngology, University of Washington, Seattle, WA, USA
3 SafKan Health, Redmond, WA, USA

Abstract
Cerumen (commonly referred to as earwax) is a normal and natural mixture of secretions and sloughed epithelial cells in the external auditory canal intended to protect, clean, and lubricate the canal. However, when an accumulation of cerumen occurs, it is diagnosed as an impaction. Patients with cerumen impaction may experience adverse symptoms including conductive hearing loss, tinnitus, dizziness, and ear pain (Schwartz et al., 2017). This paper reports on the results of an interventional trial on the safety and effectiveness of the FDA-cleared OtoSet® Ear Cleaning System (v1.0), an automated ear cleaning device indicated to remove excess cerumen from the external ear canal with irrigation and micro-suction. OtoSet® features body temperature irrigation directed from solution containers through disposable ear tips and towards the walls of the ear canals to break down cerumen. Continuous micro-suction draws the water and cerumen back through the ear tips and into disposable waste containers. For this study, 75 participants 18 years of age and older were recruited. The results of analysis on the Intent-To-Treat (ITT) population and the Per-Protocol (PP) population had similarly high levels of improvement in cerumen occlusion by 1 point or greater (84% of ears; 92% of ears) on the Degree of Occlusion Scale (DOS). Of the 111 ears from 75 individuals in the ITT population, the DOS improved by 1 point or greater in 93 (84%) of ears. The mean DOS rating before application of OtoSet® was 2.9 and after was 0.76. Of the 98 ears from 65 individuals in the PP population, the DOS improved by 1 point or greater in 90 (92%) of ears. The mean DOS rating before application of OtoSet® was 2.23 and after was 0.59. There were no significant differences in subgroup analyses between right and left ears, nor between the ITT and PP populations. In terms of patient satisfaction, in both the ITT and PP populations, high levels of patient satisfaction were reported for all six questions in a five-point Likert scale response (0 most negative; 5 most positive): 1.) Comfort before device activated had mean scores of 3.97 (ITT) and 4 (PP); 2.) Comfort while device activated had mean scores of 3.7 (ITT) and 3.7 (PP); 3.) Satisfaction with the length of the procedure had mean scores of 4.5 (ITT) and 4.6 (PP); 4.) Wetness of ears post-procedure (scored in the reverse direction) had mean scores of 2.4 (ITT) and 2.2 (PP); and 5.) Comparison to previous methods for cerumen removal had mean scores of 3.96 (ITT) and 4.08 (PP). Question six asked if participants would have this procedure performed with the OtoSet® Ear Cleaning System (v1.0) again; in both the ITT and PP populations, 89% of participants indicated they would do so. For healthcare providers and patients, these results provide evidence for the safety, efficacy, and tolerability of OtoSet® when used in similar circumstances to those in this trial.

Conclusion
For patients, our results provide evidence for the safety of the FDA-cleared OtoSet® Ear Cleaning System when used in similar circumstances to those in this trial. Our findings also support the effectiveness of OtoSet® and its tolerability by patients. For healthcare providers, our findings provide evidence that would support use of this device in healthcare settings, indicating the potential to provide a more convenient way for this common procedure to be performed. For researchers, there are several potential further areas for research. Replicating the findings among individuals attending primary care or ENT clinics complaining of cerumen impaction could generate evidence for its use on a wider population. Evidence on the use of OtoSet® in real-world settings, when applied by different types of healthcare providers with different levels of training, would be valuable to support wider use in healthcare. Generating data on the direct and indirect costs (e.g., costs of treatment, patient and healthcare provider education, time costs, caregiver costs) associated with using OtoSet® versus alternative treatments would be valuable to inform a cost-effectiveness analysis.