Clinical

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

Authors
1 Matthew Thompson MD, MPH, DPhil
3 Jeffrey Bower, PhD
1 Bianca Frogner, PhD
2 Sunil K. Ummat, MD, MBA
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 OtoSet® Ear Cleaning System (v1.0), an FDA-cleared automated ear cleaning device indicated to remove excess cerumen from the external ear canal with irrigation and micro-suction. OtoSet® features 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 body temperature 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.

Score	Degree of Occlusion
0	No occlusion: no effective impairment of tympanic membrane visualization due to cerumen
1	Mild occlusion: slight impairment of tympanic membrane visualization due to cerumen
2	Moderate occlusion: significant impairment of tympanic membrane visualization due to cerumen
3	Complete occlusion: complete impairment of tympanic membrane visualization due to cerumen

Setting
Rainier Clinical Research Center was established more than 30 years ago. Their physicians have extensive research experience and hold faculty positions at the University of Washington Medical School. Rainier Clinical Research Center has completed over 600 studies for more than 200 sponsors and contract research organization (CRO) clients.

Study Population
Participants were eligible for inclusion if they met the following criteria: a) were over the age of 18, and b) had mild, moderate, or complete occlusion of the tympanic membrane based on the DOS (Sharp et al., 1990) in one or both ears as determined by a Research Nurse. Exclusion criteria included stenotic or atretic ear canals, known or suspected otitis externa or acute otitis media, known or suspected tympanic membrane perforation, known or suspected tympanostomy tubes present, history of prior otologic surgery other than tube insertion, history of trauma to the ear, known significant sensorineural hearing loss, and neoplastic or inflammatory disorders of the ear. Each participant was compensated $60 for their participation in the study.

Intervention
The OtoSet® Ear Cleaning System (v1.0) (see Figure 1) is an FDA-cleared medical device designed to remove cerumen quickly and safely from the external ear canal. OtoSet® features 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 body temperature water and cerumen back through the ear tips and into disposable waste containers.

The study protocol was approved by the WIRB (Advarra IRB Pro00048614) in January 2021. After obtaining informed consent, information was collected and recorded on participant demographics and previous use and timing of any ear cleaning methods. Participants were able to withdraw from the study at any time if they or the Investigator considered that it was not in the participant’s best interest to continue. For participants with severe occlusion and/or at the discretion of the Research Nurse, five drops of Debrox® cerumenolytic were applied to that ear and left in place for 15 minutes. The use of BIONIX® Safe Ear Curettes by the Research Nurse were permitted when cerumen impactions were migrated and softened after five cleaning cycles were applied with OtoSet®.

Up to five automated 30-second cleaning cycles were applied with OtoSet®. After each cleaning cycle, the Research Nurse inspected the ear canal with a digital otoscope and OtoSet® was reapplied as necessary. A post-procedure image of the ear canal was obtained using the same digital otoscope. Immediately following the procedure, participants were given a short paper-based questionnaire, which included the following close-ended six questions answered with a five- point Likert scale, ranging from 1 “most negative” to 5 “most positive,” regarding their experience of the procedure:

1. How would you rate the comfort of this new ear cleaning device, before it was activated?
2. How would you rate the comfort of this new ear cleaning device, while it was activated?
3. How satisfied were you with how long the procedure lasted with this new ear cleaning device?
4. How wet did you get during and/or after the procedure with this new ear cleaning device?
5. If you have had your ears cleaned before with a different tool or device, how did this new device compare?
6. Would you have this procedure performed again with this new ear cleaning device? 

The National Cancer Institute’s Common Terminology Criteria for Adverse Events (v4.03) (2010) was used to assess and grade severity of a potential adverse event, and its relationship to the study device. The research team performed the assessments. No severe or life- threatening adverse events were recorded.

 

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