ABSTRACT
Objective
Consumer interest in ear hygiene has created an industry worth $2 billion, offering tools claiming to assist in cerumen removal. In this study, we aimed to compare the efficacy of self‐operated over‐the‐counter (OTC) cerumen removal devices.
Methods
A community‐based, prospective randomized trial was conducted at the Driven to Discover Research Facility at the Minnesota State Fair. A total of 529 adults aged ≥ 18 years were prospectively recruited; 149 met inclusion criteria for randomization to one of four OTC cerumen removal devices (cotton swab control, irrigator, powered and non‐powered spiral tools). Cerumen burden and complications were evaluated via video‐otoscopy by otolaryngologists before and after self‐use of the assigned device using an objective grading system. Surveys on cerumen removal practices and consumer attitudes were completed. Group sociodemographic, survey, and cerumen burden data were compared between groups.
Results
Of 147 randomized trial participants with moderate to excessive cerumen in at least one ear (mean age 49 years, 48% female), 130 (88%) showed no improvement or worsening of cerumen burden grade following device use. There was no significant difference in the efficacy of the four OTC cerumen removal device groups. Observed complications included medial displacement of cerumen (17%), pain or discomfort (n = 7, 5%) and canal trauma (1%). While some participants would consider purchasing (29%) or recommending the device they used to others (27%), their preferred price point ($10–$20) was lower than the market price for all devices except cotton swabs.
Conclusion
Commonly used OTC cerumen removal devices did not result in a meaningful reduction of cerumen burden when used by the public and did not show superiority to cotton swabs. While it is unknown if device efficacy would improve with repeated use and familiarization, these findings do not currently support routine use of OTC cerumen removal devices for removal of excess cerumen.
Level of Evidence
Level II, randomized controlled trial.
Keywords: cerumen, cerumen removal, cotton swabs, earwax, over‐the‐counter devices
1. Introduction
Cerumen is a substance naturally produced in the ear canal composed of exfoliated skin cells and secretions produced by the glandular cells in the cartilaginous portion of the canal [1]. Failure of the natural self‐cleaning mechanism of the ear canal can lead to excessive accumulation of cerumen and cerumen impaction [1]. Clinical practice guidelines support management of excess cerumen and cerumen impaction with cerumenolytics, irrigation, and manual removal with instruments by healthcare providers [1]. However, in response to a growing public interest in ear hygiene, there is now a $2 billion industry of products designed for at‐home ear cleaning, particularly targeted toward cerumen removal [2, 3].
In addition to cotton swabs, consumers have easy access to a range of tools including bulb irrigators, vacuums, curettes, and other instruments sized for ear canal insertion. There is a paucity of research on the efficacy of currently available devices and techniques, particularly when they are self‐administered rather than overseen by a medical professional [4, 5]. The medical community has explicitly cautioned against many of these products given the potential risks [1]. With a growing amount of ear cleaning occurring outside of medical facilities, consumers, and clinicians alike need objective data regarding the safety and efficacy of these new tools and practices.
In this study, we aimed to evaluate the efficacy of four popular over‐the‐counter (OTC) cerumen removal devices when used by untrained adults in a community‐based setting. Additionally, we sought to identify factors that contribute to consumer use and purchase of OTC cerumen removal devices.
2. Materials and Methods
This study was approved by the University of Minnesota Institutional Review Board (STUDY00019178).
2.1. Study Population
Participants were prospectively recruited at the Driven to Discover (D2D) Research Facility over 1 day of the 2023 Minnesota State Fair. Located in a metropolitan area adjacent to the University of Minnesota's campus, D2D is a turnkey research facility where investigators recruit and collect data from fairgoers in a highly efficient manner. Approximately 20% of the population of the state of Minnesota attends the Fair each year; 55,000 individuals entered D2D over 12 days of the 2023 Fair [6].
Written informed consent was obtained (n = 529). Inclusion criteria were age 18 years or older, ability to read English, and no active otologic infection or otorrhea. All participants completed surveys on sociodemographics, ear hygiene practices, and consumer preferences for cerumen removal devices (Data S1). Each ear was examined by an otolaryngologist using a digital otoscope (Anykit MS450 digital otoscope, Anykit, Irvine, CA), and representative photographs were taken. The cerumen burden in each ear was graded in real time based on preestablished criteria: minimal (< 25% of the tympanic membrane view obscured by cerumen), moderate (26%–50% obscured), excessive (51%–75% obscured), and impaction (> 75% obscured).
2.2. Randomized Cerumen Removal Device Trial
The study flow diagram is provided in Figure 1. Following the initial otoscopic exam, participants with moderate or excessive cerumen burden in at least one ear were offered participation in the OTC cerumen removal device trial. Participants were excluded if both ears had either minimal cerumen burden, which would preclude assessment of improvement, or complete or near complete cerumen impaction (> 75% obscured), given concern for worsening impaction in a community setting. Additional exclusion criteria were tympanic membrane perforation, other tympanic membrane pathology, or use of anticoagulant medication.
FIGURE 1.
Device trial study flow diagram.
Three popular OTC cerumen removal devices were used in the trial: the Elephant Ear Washer Bottle System (hand bulb‐pressured irrigator bottle, using distilled water, $52.95) (Doctor Easy Medical Products, Orange Park, FL), Tvidler Tool (non‐powered, manually operated tool with pointed spiral silicone tip, $24.95) (Tvidler, Brentwood, TN), and Ototip Electric Earwax Remover (battery powered tool with rotating rounded spiral tip, $49.99) (pNeo, Denton, TX), all purchased from http://Amazon.com on August 11, 2023. These tools were compared to cotton swabs as a control. These devices were selected due to the popularity of online sales, use of disposable tips, and their unlikelihood of penetrating the tympanic membrane based on their dimensions. Accordingly, the cotton swab handle was trimmed to a length of 2.5 cm to prevent inadvertent tympanic membrane injury.
Trial participants (n = 149) were block randomized to a device (Figure 1) and provided with the manufacturer‐supplied instructions for review prior to using the device. Investigators did not offer assistance in device use. The participant trialed the device in one qualifying ear canal for a minimum of 30 s, followed by completion of a survey on their perceptions of the device. An observing investigator completed an assessment of perceived competency and efficacy of participant device use. The video‐otoscopic exam was repeated and representative photographs obtained. Two out of 149 consented participants withdrew from the device trial after randomization but before device use for reasons unrelated to study activities; thus 147 participants completed the trial. Pre‐ and post‐intervention photographs were assessed by study team members, documenting cerumen location (medial/bony canal, lateral/cartilaginous canal, both), evidence of tympanic membrane contact or irritation (erythema, ecchymosis, hair, cerumen), or evidence of canal trauma (erythema, ecchymosis, hair, foreign body).
The primary outcome was change in cerumen burden following the device trial. This was assessed by study team members in two ways: (1) Comparing objective change in cerumen grade determined by cross‐sectional area occluded by cerumen in the pre‐ and post‐intervention photographs, with improvement defined as reduction by one or more grades, and no improvement defined as no change or worsening by one or more grades; (2) Rater's impression of cerumen removal, based on the investigator's observation of cerumen present on the tool after use or in the irrigation solution ejected from the ear. This measurement informed the degree to which the device interacted with the cerumen regardless of its ultimate efficacy.
2.3. Data Analysis
Initial sociodemographic and survey data were compared between all participants and those included in the device trial using Fisher's exact test. Differences in cerumen burden and complications between devices were compared by Fisher's exact test. Statistical significance was defined as p < 0.05, two‐tailed.
3. Results
3.1. Participant Characteristics
Participant characteristics are summarized in Table 1. Of 529 survey participants, 147 (28%) met inclusion criteria, consented, were randomized, and completed the OTC cerumen removal device trial (Figure 1). In the device trial, the mean [SD] age was 49 [19] years (range 18 to 89 years), 70 (48%) were female, 122 (82%) were white, and 110 (74%) reported that they routinely perform ear canal hygiene at home.
TABLE 1.
Participant characteristics.
| All survey participants (N = 529) | Device trial participants (N = 147) | |
|---|---|---|
| Age, years, mean [SD] | 45 [17] | 49 [19] |
| Gender | ||
| Female | 291 (55%) | 70 (48%) |
| Male | 235 (44%) | 77 (52%) |
| Other | 3 (1%) | 0 (0%) |
| Ethnicity | ||
| Non‐Hispanic | 506 (96%) | 138 (94%) |
| Hispanic | 22 (4%) | 9 (6%) |
| Race | ||
| White | 436 (82%) | 122 (82%) |
| Asian | 54 (10%) | 13 (9%) |
| Black or African American | 11 (2%) | 4 (3%) |
| Other | 28 (6%) | 4 (6%) |
| Education | ||
| High school | 70 (13%) | 20 (14%) |
| Undergraduate college | 302 (57%) | 84 (57%) |
| Graduate/professional degree | 157 (30%) | 43 (29%) |
| Living location | ||
| Rural town/area | 39 (7%) | 3 (2%) |
| Small city/town | 81 (15%) | 22 (15%) |
| Suburb near large city | 254 (48%) | 68 (46%) |
| Large city | 155 (30%) | 54 (37%) |
| Do you routinely clean your ear canals? | ||
| Yes | 447 (85%) | 110 (74%) |
| No | 82 (15%) | 39 (26%) |
| Initial cerumen grade a | ||
| No wax (0%) | 121 (23%) | 0 (0%) |
| Minimal wax (1%–25%) | 223 (42%) | 0 (0%) |
| Moderate wax (25%–50%) | 75 (14%) | 72 (49%) |
| Excessive wax (50%–75%) | 79 (15%) | 75 (51%) |
| Impaction (75%–100%) | 28 (5%) | 0 (0%) |
For all survey participants, this indicates the grade in the worse ear; for trial participants, it indicates the grade in the ear used for the trial.
3.2. Outcome: Consumer Factors in Selection of OTC Cerumen Removal Devices
Of all survey participants, 381 (72%) reported use of cotton swabs and 40 (8%) participants reported having owned another OTC cerumen removal device. When considering the purchase of an OTC cerumen removal device, 219 (41%) participants indicated interest in purchasing a device, 236 (45%) were unsure, and 74 (14%) had no interest (Table 2). Of participants who would consider purchasing a device (interest in purchase or unsure), 268 (59%) indicated they would pay up to $20 for a device and 76 (17%) would be willing to pay more than $40. Safety (n = 100, 22%), price (n = 93, 20%), and endorsement by healthcare professionals (n = 78, 17%) were reported as the top three factors that would influence participants to consider a device purchase (Table 2).
TABLE 2.
Price preference and most important factors in ear cleaning tool purchase a .
| Participants (n, %) | |
|---|---|
| Would you buy a cerumen removal device? (N = 529) | |
| Yes | 219 (41) |
| No | 74 (14) |
| Unsure | 236 (45) |
| Price preference (N = 454) b | |
| < $10 | 105 (23) |
| $10–$20 | 163 (36) |
| $21–$39 | 110 (24) |
| > $40 | 76 (17) |
| Most important factor in purchase (N = 455) b | |
| Marketed as safe | 100 (22) |
| Price | 93 (20) |
| Endorsed by a healthcare professional | 78 (17) |
| Marketed as effective | 72 (16) |
| Method of cleaning (e.g., curette, irrigator) | 64 (14) |
| Other | 48 (11) |
There were no significant differences between participants included and excluded from the device trial.
By design, this question was not administered to participants who reported they would not buy a cerumen removal device. One participant did not provide a price preference.
3.3. Outcome: Over‐the‐Counter Cerumen Removal Device Trial
A total of 147 participants completed the device trial. Per the observing team member, nearly all participants read the instructions (n = 136, 93%) and used the device as intended (n = 146, 99%). The physician assessments of outcomes with each device are provided in Table 3.
TABLE 3.
Objective and subjective impact of OTC cerumen removal tool on cerumen burden (N = 147).
| OTC cerumen removal tool | p | ||||
|---|---|---|---|---|---|
| Cotton swab (N = 37) | Powered spiral tool (N = 36) | Non‐powered spiral tool (N = 38) | Irrigator (N = 36) | ||
| Objective change in cerumen grade | |||||
| No change or worsened classification grade | 33 (89%) | 34 (94%) | 32 (84%) | 31 (86%) | 0.5044 |
| Improved classification grade | 4 (11%) | 2 (6%) | 6 (16%) | 5 (14%) | |
| Rater impression of removal of some cerumen (visible on device or irrigant) | |||||
| No cerumen removed | 26 (70%) | 26 (72%) | 20 (53%) | 18 (50%) | 0.1023 |
| Some cerumen removed | 11 (30%) | 10 (28%) | 18 (47%) | 18 (50%) | |
Out of all 147 trial participants, 17 (11.6%) experienced an objective improvement in cerumen grade and 130 (88.4%) experienced no objective change or a worsening in cerumen grade. There was no statistical difference in the objective change in cerumen grade between the four device groups (Table 3). The majority of participants had no change in cerumen grade regardless of the device. Cerumen grade was improved in two (6%) participants with the powered spiral tool, four (11%) participants with cotton swabs, five (14%) participants with the irrigator, and six (16%) participants with the non‐powered spiral tool. Device use worsened the cerumen grade in a minority of participants (< 10%).
When considering the rater impression of whether cerumen was removed based on its presence on the tools or in the irrigation solution, the irrigator and non‐powered spiral tool were observed to remove some amount of cerumen in 18 (50%) and 18 (47%) of participants, respectively, whereas the cotton swab and powered spiral removed some amount of cerumen in 11 (30%) and 10 (28%) participants, respectively, but this difference was not statistically significant (p = 0.1023) (Table 3).
Complications are presented in Figure 2. Medial displacement of cerumen was the most common complication, observed in 25 (17%) participants, and canal trauma was observed in two (1%) participants. There were several reported instances of pain or discomfort with use (n = 7, 5%). There were no statistical differences in complication rates between groups (p = 0.4559).
FIGURE 2.
Complications, by device.
Participant impressions following the device trial are outlined in Table 4. 110 (75%) participants reported this as the first time using their assigned device. This was similar among the irrigator, non‐powered spiral tool, and powered spiral tool, but only eight (22%) participants trialing the cotton swabs reported this as their first time using the device (p < 0.00001). 140 (95%) participants understood the provided instructions (p = 0.7604) and found the devices easy to use (p = 0.6752). The device was considered to be safe by 112 (76%) participants, with cotton swabs users reporting this at a lower rate (62%) than those assigned to other devices (p < 0.05). For all devices, 114 (78%) participants did not perceive an improvement in cerumen burden (p = 0.2989); however, 76 (52%) participants indicated they would be interested in trialing the device again (p = 0.1234). Only 41 (28%) participants indicated they would recommend their trialed device to others for use (p = 0.5954). Those who trialed the cotton swabs were most likely to be interested in purchasing their device. Of the participants who would purchase their device (n = 44, 30%), price preferences varied between the device groups (p < 0.0005). Those who trialed the cotton swab overwhelmingly preferred a price point less than $10. Participants interested in purchasing an irrigator, non‐powered spiral tool, or powered spiral tool were more likely to prefer a price between $10 and $20 (n = 16, 70%), which are below the market prices of the devices.
TABLE 4.
Trial participant perceptions of cerumen removal devices.
| Cotton swab (N = 37) | Powered spiral tool (N = 36) | Non‐powered spiral tool (N = 38) | Irrigator (N = 36) | p | |
|---|---|---|---|---|---|
| Device was easy to use | 36 (97%) | 34 (94%) | 35 (92%) | 35 (97%) | 0.6752 |
| Device was comfortable | 29 (78%) | 29 (81%) | 30 (79%) | 24 (67%) | 0.4872 |
| Device felt safe | 23 (62%) | 26 (72%) | 31 (82%) | 32 (89%) | < 0.05 |
| Would recommend this device to others | 11 (30%) | 7 (19%) | 11 (29%) | 12 (33%) | 0.5954 |
| Would purchase this device | 21 (57%) | 4 (11%) | 11 (29%) | 8 (22%) | < 0.001 |
| Price preference < $10 | 20 (95%) | 1 (25%) | 3 (27%) | 1 (13%) | < 0.0005 |
| Price preference $10–$20 | 1 (5%) | 3 (75%) | 6 (55%) | 7 (87%) | |
| Price preference $21–$39 | 0 (0%) | 0 (0%) | 2 (18%) | 0 (0%) |
4. Discussion
In this community‐based, randomized trial of self‐administration of OTC cerumen removal devices, we observed that a single use of any of four selected devices resulted in an improvement in cerumen grade in just 16% of participants, leaving 88% with either no change or a worsening in cerumen grade. There was no difference in the rate of improvement between the four groups. Specifically, the three more costly home removal devices, comprised of an irrigator and powered and non‐powered spiral tools, were not superior to the more affordable and accessible cotton swab. Team members observed that the devices interacted with the cerumen and resulted in the removal of some amount of cerumen in 57 (39%) participants. While we hypothesized that the visible cerumen on the device or in the irrigation fluid would give users the impression of successful device use, most participants (78%) reported that they did not perceive a subjective improvement in their cerumen burden and the lack of objective changes in cerumen grade suggests that the extractions were not clinically meaningful. Complications from device use were rare. Although infrequent, medial displacement of cerumen was the most common complication, which was expected given that all devices required insertion of a foreign body into the ear canal.
Cotton swabs are the most commonly used tools for cerumen removal despite extensive recommendations against their use. The latest cerumen removal guidelines published by the American Academy of Otolaryngology–Head and Neck Surgery (AAO‐HNS) continue to reinforce that cotton swabs should not be used at home to remove cerumen due to increased risk for cerumen impaction and damage to the ear canal, tympanic membrane, and middle ear structures that may result in hearing loss [1]. Despite these recommendations, the use of cotton swabs for cerumen removal is prevalent among the public, which was affirmed by the present study with 381 (72%) of survey participants reporting routine use. The AAO‐HNS guidelines approximate that 9% of cotton swab users experience ear injuries as a result of cleaning, including abrasions, tympanic membrane (TM) perforation, and cerumen impaction. We recognize that the risk profile of a full‐length cotton swab was not completely replicated by the reduced‐length swab utilized in this study. Accordingly, the complication rate observed in our study was lower, with one instance of cerumen impaction and no instances of canal trauma or TM perforation. The reduction in length of the cotton swabs was done to prevent trauma in the study setting. It is unclear if repetitive home use of a reduced‐length cotton swab would be associated with lower risk of trauma but the present study did not demonstrate meaningful improvement in cerumen burden with this approach nonetheless.
Both the powered and non‐powered spiral tools were found to be ineffective at cerumen removal. Spiral head designs are marketed as offering greater surface area to catch and remove ear wax when twisted without pushing cerumen more medially into the canal; further, their multiuse potential could be viewed as a sustainable option compared to disposable swabs. In this study, the powered spiral tool was the least effective of all the devices, only reducing the cerumen burden in two participants (6%). The non‐powered spiral tool improved cerumen burden in six users (16%). This is contrary to the findings of a similar study that investigated the efficacy of a non‐powered spiral cerumen removal device when operated by an otolaryngologist [7]. Using an analogous grading system, but defining improvement as a reduction of two or more cerumen burden grades, they observed improvement in 86.4% of treatments. The large difference in outcomes is likely multifactorial. Compared to the general population in our study, tool use by a trained otolaryngologist offered greater skill, experience, and persistence with multiple attempts at cerumen evacuation reported. This study also utilized a different design of the spiral tool which allowed it to go much deeper and closer to the TM, which may not be as safe for self‐administration. It is possible that longitudinal use and practice may allow non‐medically trained adults to become proficient with spiral tools and improve cerumen removal; however, further validation is required. Additionally, design may be a key factor in the efficacy of spiral tools, but the risk of TM trauma should be considered in those designs that go deeper into the ear canal.
Prior studies investigating the efficacy of at‐home irrigation found at‐home irrigation significantly reduces cerumen burden and symptoms with repeated weekly use for several months [8, 9]. We suspect that there are two main contributors to the difference in findings. Firstly, we assessed inexperienced users in a single setting as compared to repeated, longitudinal use. Efficacy may improve with user practice and produce similar results as seen when used by trained healthcare providers. Secondly, these studies utilized isopropyl alcohol solutions as the irrigating solvent as compared to the distilled water used in our trial. Although the manufacturer recommends filtered, distilled, or boiled then cooled water, we suspect the addition of isopropyl alcohol or another cerumenolytic contributes to improved success [9]. Recent studies have also found irrigation to be more effective when pretreating with a cerumenolytic [10]. In the present study, the irrigator was the least likely to push cerumen medially, possibly related to fluid dynamics as well as its more slender tip design compared to the other devices. Irrigators may be effective options for at‐home cerumen removal, but our findings suggest there may be a learning curve or additive effect to their use.
Considering OTC cerumen removal device purchase preferences, price was ranked as the second most important factor. Of all participants included in the initial survey, the ideal price range was from $10 to $20. The non‐powered spiral tool was closest to this desired price range at $24.95 while the powered spiral tool and the irrigator cost $49.99 and $52.95, respectively. With the exception of cotton swabs that are routinely sold as low as $0.01 per swab, these three devices exceed what customers in the region of the study state they are willing to pay. Curiously, participants indicated interest in trying their device again after the trial despite the poor results (n = 76, 52%), and up to one third would consider purchase of the device or would recommend it to others. This may reflect the concomitant endorsement of ease and comfortability of use reported by most participants.
There are limitations to our study. We assessed a single use of each device by inexperienced users and could not assess if the efficacy of these devices may change over time. Cerumen grading systems limit the ability to identify small changes in cerumen burden. Post‐device use grading could be skewed by cerumen movement that alters the cross‐sectional appearance but does not change the total volume. These are limitations of studies assessing cerumen burden in general and prompted us to include an additional assessment of visible cerumen on the device or in the irrigation fluid. Within the device trial, we requested a minimum of 30 s of device use; however, there was natural variability in the length of use beyond that. This was intentional, as to best mimic the effort one would put in at home. Additionally, our sample size may have restricted the ability to observe small differences in device efficacy or complication rates.
5. Conclusion
Cerumen is not harmful and does not require removal in the majority of patients. The findings of this study are intended to provide information useful for patients considering the purchase of cerumen removal devices and for clinicians who provide patient education. We found that popular OTC cerumen removal devices used by the public did not result in a meaningful improvement in cerumen burden. Both in terms of efficacy and risk of complications, the three tools evaluated did not offer benefits over cotton swabs and their price points exceeded what the average participant was willing to pay. There is a need for more evidence‐based self‐administered options for individuals with excess cerumen. Patients with medical concerns regarding their cerumen should be counseled to seek treatment from a trained healthcare professional.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Data S1: Sociodemographic, ear hygiene, consumer habits, and cerumen removal device impressions questionnaires.
Acknowledgments
The authors wish to thank Tyler Gathman, Rashika Shetty, Bailey Borowicz, Nicholas Hable, Soorya Todatry, and the staff at the Driven To Discover (D2D) Research Facility at the Minnesota State Fair for their assistance in conducting the trial.
Kamm W. E., Tolan M. M., Kennedy C. L., Choi J. S., Marmor S., and Adams M. E., “Efficacy of Over‐the‐Counter Cerumen Removal Devices: A Randomized Trial,” Laryngoscope Investigative Otolaryngology 10, no. 6 (2025): e70313, 10.1002/lio2.70313.
Funding: This work was supported by the Minnesota Lions International Hearing Foundation (M.M.T. and M.E.A.).
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1: Sociodemographic, ear hygiene, consumer habits, and cerumen removal device impressions questionnaires.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.