OTC hearing aids and cerumen: why ear care products belong in every audiology-adjacent portfolio
The rapid expansion of over-the-counter (OTC) hearing aids has shifted a significant portion of hearing care out of the clinic and into the hands of consumers. Yet the audiology channel has been slow to respond: clinically validated ear care products that address this gap remain largely absent from OTC hearing aid portfolios, despite a growing body of evidence that makes the case for their inclusion.
How cerumen buildup compromises OTC hearing aid performance and patient satisfaction
Earwax buildup is more prevalent among hearing aid users than in the general population. The earmould or receiver housing physically obstructs the ear canal’s natural self-cleaning mechanism, increasing the likelihood of earwax impaction over time. Published evidence confirms that hearing aid users are among the highest-risk groups, alongside adults over 50, in whom cerumen glands atrophy to produce drier, harder wax, and men, in whom coarser canal hair further impedes natural clearance.
The consequences for device performance are direct. Earwax buildup can block the hearing aid earmould, acoustic tubing, or receiver, causing the device to appear faulty. For users of OTC hearing aids, without an audiologist to consult, a blocked device is likely to be perceived as a product failure rather than a cerumen management issue, generating returns, negative reviews, and loss of brand confidence. Separately, unmanaged earwax impaction may require higher device gain than the hardware can deliver, compounding dissatisfaction in a segment where OTC devices already tend to underfit relative to prescription targets.
A UK audit across three NHS hearing aid services found that 5–8% of new adult referrals had earwax requiring management, a proportion that is likely higher among OTC hearing aid users, who bypass professional screening entirely.
Cerumenolytic products as a portfolio complement to OTC hearing aids
The clinical evidence base for cerumenolytic ear care solutions is well established. Systematic reviews confirm that treatment with cerumenolytics is more effective than no treatment, that adverse effects are rare and mild. Sprays, in particular, are gaining ground in the market for their convenience and reduced handling compared to droppers, making them a natural fit for users managing cerumen alongside a hearing device.
What the evidence does not support is the assumption that mechanical devices are a viable self-managed alternative. Clinical trials have consistently found that popular OTC cerumen management devices (irrigators, spiral tools, and cotton swabs) fail to deliver meaningful outcomes when self-administered by untrained users, with complications including compression and pushing of earwax deeper into the ear.
Sprays and drops, by contrast, are easy to use, carry a well-documented safety profile, and are already the preferred format in pharmacy self-care settings. This combination helps explain why the cerumenolytic agents market is growing at 5.8% annually and is projected to reach USD 2.2 billion by 2030, driven by ageing populations, rising hearing device adoption, and expanding self-managed ear care.
Cerumen management: what audiologists, distributors, and end users need from OTC ear care
Requirements differ across the value chain, but they are more complementary than they might appear:
- End users need a product that is safe for regular use, effective at softening accumulated cerumen without discomfort, and simple enough to use without professional guidance. Given that safety and healthcare professional endorsement usually rank as the top purchase considerations in consumer surveys, the clinical credibility of the product is a direct commercial lever, not simply a regulatory consideration.
- Audiologists and hearing professionals, even those operating adjacent to the OTC channel, need to be able to recommend products with confidence. This means peer-reviewed clinical evidence, a well-defined mode of action, and CE marking or equivalent regulatory standing. Products that have been validated in hearing aid user populations carry particular weight in audiology services contexts.
- Portfolio managers need products that complement rather than cannibalise existing lines, carry defensible clinical claims, and are free from regulatory ambiguity. A CE-marked ear care medical device, backed by post-market surveillance data, provides a significantly more stable commercial foundation than an unclassified or cosmetically positioned product.
The audiology channel has long recognised the commercial logic of offering accessory products alongside hearing devices, a model that translates directly to pharmacy and OTC settings, where a companion ear care product increases basket size and drives repeat purchase.
Market signals: why the OTC audiology channel is ready for dedicated ear care products
Several converging trends make this a structurally favourable moment to position ear care products within the OTC hearing aids channel:
- OTC hearing aid adoption is accelerating, expanding the addressable population of users who lack routine audiological screening. Every new OTC hearing aid user is a potential customer for cerumen management products, particularly given that device use is itself a risk factor for earwax impaction.
- Mechanical self-management tools are failing to meet consumer needs. Clinical trial evidence is unambiguous: popular mechanical devices do not deliver meaningful cerumen management outcomes in untrained users. This creates a validated clinical argument for cerumenolytic products as the evidence-based, accessible alternative.
- Self-care is the dominant policy direction. Policymakers across Europe and the UK are actively encouraging patients to manage routine conditions without unnecessary clinical contact. Cerumen management is explicitly included in published self-management guidance, validating the OTC positioning of well-designed ear care products.
- Retail and online pharmacy are the growth channels, aligning perfectly with where OTC hearing aids are already gaining shelf space.
Unmanaged cerumen is one of the most common and preventable causes of poor OTC hearing aid performance, and one of the most straightforward to address with the right product in the portfolio. Mitelos has spent over a decade developing clinically validated ear care solutions used by more than five million patients across Europe.
If you are building or expanding an audiology-adjacent portfolio, our team can walk you through our product range, clinical evidence package, and commercial partnering models.
References
Aaron K, Cooper TE, Warner L, Burton MJ. Ear drops for the removal of earwax. Cochrane Database Syst Rev. 2018 Jul 25;7(7):CD012171. doi: 10.1002/14651858.CD012171.pub2
Adams B, Theobald S, Tymms R, Munro KJ. Is impacted earwax a hidden obstacle for OTC hearing aid users? Int J Audiol. 2025;1–3. doi: 10.1080/14992027.2025.2598639
Bankaitis Smith AU. Resale Product and Accessory Opportunities for Audiology Practices. Semin Hear. 2019 Aug;40(3):232-244. doi: 10.1055/s-0039-1693448
Kamm WE, Tolan MM, Kennedy CL, Choi JS, Marmor S, Adams ME. Efficacy of Over-the-Counter Cerumen Removal Devices: A Randomized Trial. Laryngoscope Investig Otolaryngol. 2025 Nov 18;10(6):e70313. doi: 10.1002/lio2.70313
Strategic Market Research. Cerumenolytic Agents Market – Forecast 2024–2030 [Internet]. Sambalpur: Strategic Market Research; 2026 [cited 2026 Jun 8]. Available from: https://www.strategicmarketresearch.com/market-report/cerumenolytic-agents-market