Abstract
The emergence of Over-the-Counter (OTC) hearing aids is changing the way people access hearing support around the world. In Canada, however, this shift raises complex questions about how these devices are regulated, whether they are safe to use without professional guidance, and what role audiologists will play in long-term care. While American consumers have been able to buy OTC hearing aids since 2022, thanks to FDA-backed legislation, Canadians are still waiting for clear rules. So far, only a handful of devices, such as the Apple AirPods Pro II in “hearing aid mode,” have been approved under Class II Medical Device licensing.
For Echo Audiology, a Person-Centered Care Clinic located in Orléans, Ontario, this conversation goes beyond product innovation and bringing you the latest gadgets. We are committed to your safety, trust, and delivering care that is backed by science. This blog aims to demystify OTC hearing aids, explore what they can (and cannot) do, and explain why professional audiological assessments and counselling remain essential for effective hearing care. We will also take a closer look at how these self-fitted devices are marketed as affordable, easy-access alternatives to prescription hearing aids, and why this promise can be misleading without the right professional guidance.
We draw on the latest guidance from Health Canada and the Canadian Academy of Audiology to highlight some important points about OTC hearing aids. These include potential risks like getting the wrong diagnosis, turning the volume up too much, and missing out on key checks like real ear measurement (REM) verification. We also discuss the nuances of Apple’s recent certification. Its “hearing aid mode” might be helpful and work for some users, but it is not a substitute for personalized care from a hearing professional, especially if your hearing needs are more complex or still undiagnosed.
Ultimately, this article aims to help you make informed choices about over the counter (OTC) hearing aids with clear, research-based information you can trust. We’ll walk you through safer, more effective options, available funding support, and why a full hearing assessment is the best first step. At Echo Audiology, we serve you with honest advice, personalized care, and evidence-based audiology practices, because we know that hearing health is never one-size-fits-all.
Introduction: Hearing Aid Tech Is Evolving – Are You Plugged In?
Hearing loss is one of the most underdiagnosed yet life-altering health issues affecting Canadians today. According to Statistics Canada, nearly 40% of adults aged 60 and over experience some degree of hearing loss. Inevitably, this number is expected to rise sharply as our population ages. What many of us may not realize is that hearing health is not an area of concern only for older adults. Younger individuals are also increasingly affected for a variety of reasons such as exposure to prolonged noise through recreational or occupational settings or even due to hereditary hearing loss. Despite this, many do not seek timely help due to cost concerns, societal stigma, or simply not knowing where to start.
In recent years, the global audiology landscape has shifted dramatically with the introduction of Over-the-Counter (OTC) hearing aids. These devices, intended for adults with perceived mild to moderate hearing loss, offer a do-it-yourself path to amplification — no prescription, hearing test, in-person fitting or counselling required. From ‘clinic’ to ‘click’, the new age of hearing aids appears to be here. This model has gained traction in the United States, where the FDA introduced formal guidelines in 2022 to regulate OTC hearing aid availability. Supporters heralded the move as a game-changer, promising more affordable access, especially in underserved or rural areas.
But the situation in Canada is markedly different. As of early 2025, the Canadian government has taken a more measured approach. Health Canada has yet to approve a full suite of OTC hearing aids for general distribution, citing valid concerns around safety, misdiagnosis, and device misuse. To date, only one OTC-like product — the Apple AirPods Pro II — has received a Class II Medical Device License for its “hearing aid mode”. Not surprisingly, just like with any other technological innovation, more options lead to more questions! Can wireless earbuds really substitute for regulated hearing aids? And more importantly, what are the risks of bypassing professional care?
At Echo Audiology, we view these developments beyond technological trends. In our opinion, which is based on several years of hearing care experience, they represent a deeper tension between convenience and clinical care. Based in Orléans, Ontario, Echo Audiology is a locally trusted, person-centered audiology clinic known for its holistic, evidence-based and medical approach to hearing wellness. For our team of audiologists, hearing healthcare is never limited to providing suitable devices. We focus on building trust, safeguarding health, and tailoring treatment to each patient’s unique condition and lifestyle.
In this blog, we will break down what OTC hearing aids are, how they differ from professionally fitted prescription devices, and what you need to understand before purchasing them, especially in Canada where regulatory oversight remains cautious. We will also:
- Explain why Health Canada has yet to approve most OTC hearing aids
- Reveal what Apple’s certification actually means for consumers
- Highlight affordable alternatives for low-income Canadians
- Discuss the ongoing, irreplaceable role of audiologists
This article is not just a technical evaluation or a policy-related conversation. It’s a healthcare discussion. If you or someone you care about is experiencing hearing difficulties, this guide will help you make informed, confident, and safe choices. Technology may offer new tools, but only professional care ensures your hearing solution is medically sound, precisely tuned, and supported for the long term.
What Are Over-the-Counter Hearing Aids?
Over-the-Counter (OTC) hearing aids are a relatively new class of medical devices designed to make hearing care more easily available to adults who suspect they have mild to moderate hearing loss. Unlike traditional prescription hearing aids, you can purchase these devices directly, without an audiological assessment, hearing test, or fitting by a regulated healthcare professional. Definitely a convenience, but not without risk!
OTC hearing aids are typically sold online or in retail stores, much like reading glasses or blood pressure monitors. They often come with smartphone apps that allow you, as the user, to self-program the device, select sound profiles, and adjust amplification levels based on your own hearing experience. Again, sounds like a DIY win, but you may stand to lose important benefits of professional hearing care and guidance.
At first glance, the concept is appealing: more autonomy, lower costs, and broader accessibility. But for many Canadians, the distinction between OTC hearing aids, personal sound amplification products (PSAPs), and prescription hearing aids remains unclear. It’s the kind of confusion that can lead to risky decisions, and our team at Echo Audiology aims to help you avoid them.
Hear, Hear! Key Differences about Hearing Aids
OTC Hearing Aids vs. PSAPs
Personal Sound Amplification Products (PSAPs) are not designed for people with hearing loss. Instead, they amplify environmental sounds for non-medical purposes, such as birdwatching, hunting, or eavesdropping in noisy environments. PSAPs are not regulated as medical devices, so using them in place of a hearing aid can lead to worsened hearing conditions if overused or improperly configured.
OTC vs. Prescription Hearing Aids
Prescription hearing aids are regulated Class II medical devices that require a professional hearing evaluation. They are custom-fit based on an individual’s audiogram, which provides a precise map of hearing loss across various frequencies. Audiologists use real ear measurements (REM) and other verification tools to ensure these devices are performing safely and optimally. More importantly, prescription hearing aids are supported by ongoing care, including adjustments, cleaning, troubleshooting, and counselling — none of which come standard with OTC devices.
Who Are OTC Hearing Aids Designed For?
The intended users for OTC hearing aids are:
- Adults aged 18 and over
- Individuals who perceive they have mild to moderate hearing loss
- People who are tech-savvy, self-motivated, and comfortable managing their own hearing care
Importantly, OTC hearing aids are not appropriate for people with:
- Moderately-severe, severe or profound hearing loss
- Fluctuating or medically complex hearing conditions
- Tinnitus, vertigo, or balance issues
- Sudden hearing loss, which could indicate a medical emergency
Why You Need to Be Cautious When Selecting Your Hearing Aids
While OTC hearing aids promise affordability, it’s important to understand the associated risks. Self-diagnosing hearing loss without a professional assessment can result in:
- Missing medical red flags like tumors (e.g., acoustic neuromas), infections, or middle ear pathologies
- Over-amplification that could worsen existing damage, especially in smaller ear canals or in noisy environments
- Frustration or abandonment of the device due to poor fit, feedback issues, or unclear usage instructions and expectations
In many cases, people who try OTC devices ultimately seek professional help after the product fails to meet their needs. Echo Audiology regularly receives patients disillusioned by retail-bought hearing aids, and are now seeking accurate assessment, counselling and proper support.
The Canadian Context
Unlike in the U.S., where OTC hearing aids are legally available under FDA guidance, Canada has not yet approved OTC hearing aids for widespread use. Health Canada’s stricter regulatory process ensures that hearing devices meet medical-grade safety and effectiveness standards. Currently, the only exception is Apple’s AirPods Pro II, and even that classification has limitations, as explored in the next section.
Key Takeaway: OTC hearing aids might be a fit for a narrow segment of the population, but they are not a replacement for professional care. At Echo Audiology, our focus is on ensuring every patient receives the right information, the right solution, and the right support, because your hearing health is too important to leave to guesswork or DIY trial-and-error.
Why Isn’t Canada Approving OTC Hearing Aids Yet?
While our neighbour, the United States, has moved forward with a consumer-first approach to hearing healthcare by authorizing over-the-counter (OTC) hearing aids under the Food and Drug Administration (FDA), Canada has opted for a more conservative and safety-oriented pathway. As of 2025, no true OTC hearing aids beyond Apple’s AirPods Pro II in “hearing aid mode” are approved for broad public use under Health Canada’s Class II medical device regulations.
As hearing professionals, we laud this cautious approach and see it as Canada’s deeper commitment to clinical oversight, patient safety, and public health education. Unlike the U.S. model, which prioritizes accessibility, the Canadian system continues to emphasize medical verification and regulated care. These are critical factors in reducing long-term health risks for individuals with hearing loss.
Why Is Canada Holding Back?
Health Canada classifies all hearing aids, including those marketed as OTC, as Class II medical devices. This means manufacturers must submit rigorous data supporting a device’s safety, efficacy, and intended use, along with demonstrating that their products do not pose undue risk if used without supervision.
Health Canada and professional organizations such as the Canadian Academy of Audiology (CAA) have highlighted the following concerns:
1. Self-Diagnosis Is Inherently Risky
Hearing loss is a complex medical issue that can stem from a variety of causes, including:
- Impacted earwax
- Ear infections or fluid in the middle ear
- Otosclerosis
- Ménière’s disease
- Acoustic neuromas (tumors)
- Noise-induced trauma
- Age-related sensorineural loss
OTC devices encourage users to self-assess their hearing, which increases the likelihood of misdiagnosis. For example, you may assume that your beloved senior’s hearing loss is due to aging, when in reality it may signal a condition that could require medical intervention. By bypassing professional evaluation, these conditions may go undiagnosed or untreated, delaying essential care.
According to a study published in JAMA Otolaryngology, 1 in 10 patients presenting with hearing loss had underlying conditions that required medical treatment rather than amplification alone (Shapiro et al., 2020).
2. Risk of Over-Amplification and Hearing Damage
Without clinical oversight, users may over-amplify sound, particularly in small or occluded ear canals. According to Boyle’s Law, increased sound pressure in confined spaces (like the ear canal) can lead to disproportionate volume levels, risking further auditory damage.
Unlike prescription hearing aids fitted with real ear measurements (REM), a gold-standard verification technique used by audiologists, OTC devices are typically tuned by the user through trial and error. This approach lacks the precision and personalization necessary to ensure safe, effective amplification.
3. Lack of Verification and Professional Support
Health Canada also emphasizes that without professional involvement, OTC hearing aid users miss out on:
- Baseline audiological testing
- Real ear verification and fine-tuning
- Medical referrals for red-flag symptoms
- Rehabilitation, counselling, and device support
The Canadian Academy of Audiology (CAA) urges the public not to equate OTC access with best-practice care. In its 2023 position statement, the CAA supported efforts to make hearing care more affordable and accessible but warned against the substitution of professional services with unverified retail solutions.
“While OTC hearing aids may help reduce barriers, they should not replace professional evaluation or verification. Clear labeling, medical screening, and clinician involvement remain essential.” – Canadian Academy of Audiology (CAA), 2023
4. Health Canada’s Patient Safety Mandate
Under Canada’s Food and Drugs Act, medical devices must prove they meet specific performance, labelling, and manufacturing standards before they are licensed. OTC hearing aids, which often market convenience and low cost, must still provide robust clinical data to show:
- That the device can be safely operated by non-experts
- That the amplification algorithm is appropriate across varied hearing profiles
- That labeling does not mislead or omit critical safety warnings
As mentioned earlier in this article, only the Apple AirPods Pro II has met enough of these criteria to receive a Class II Medical Device License till date. That approval also comes with restrictions, notably, limited battery life in “hearing aid mode,” lack of full customization, and no REM verification.
5. Public Misunderstanding and Marketing Gaps
There is growing concern that Canadian consumers do not fully understand the limitations of OTC-style devices. Misleading marketing, especially on e-commerce platforms, can lead buyers to believe these products are equivalent to regulated hearing aids. The absence of licensed audiologists in the purchasing process further exacerbates misinformation, leaving many without the education necessary to make informed choices.
In fact, Echo Audiology have encountered patients who come into the clinic after trying OTC or online-purchased amplification devices that ultimately did not have a great experience or felt it was ineffective based on their needs and expectations. In many of these cases, the affected individuals could have avoided this negative experience with a proper hearing assessment and professional guidance.
Curious why a professional evaluation matters? Learn more in our blog: Why Hearing Assessments Are Essential for Adults.
Apple AirPods as Hearing Aids — What Does the Certification Mean?
In December 2024, Apple’s AirPods Pro II received a Class II Medical Device License from Health Canada. As public interest spiked, so did a fair degree of confusion about whether these popular wireless earbuds can function as legitimate hearing aids. The certification covers features like Hearing Aid Mode, Conversation Boost, and Live Listen, all designed to amplify sound through Apple’s iOS Health ecosystem.
While this move marks a step toward greater accessibility, it’s important to understand that Apple AirPods are not true hearing aids. The license simply means the product meets certain regulatory requirements for low-risk assistive hearing functions. It does not imply that the device can diagnose, customize for complex hearing loss, or replace professional care.
What They Can Help With:
- Amplifying conversations in specific settings (e.g., noisy rooms)
- Providing temporary support for perceived mild hearing challenges
- Serving as a tech-based starting point for curious users
What They Cannot Do (and Why They Fall Short):
- Perform comprehensive hearing assessments
- Offer Real-Ear Measurements (REM) or precise programming and fine-tuning
- Support long-term hearing care or medical oversight
At Echo Audiology, we have had inquiries from the community and from patients who seem to have been misled into believing that AirPods can fully replace hearing aids, often resulting in delayed care or ineffective support for themselves or their loved ones. Moreover, using AirPods in “hearing aid mode” has limitations, including short battery life (~3 hours) and a lack of medical support. There’s also a risk of social confusion, as users wearing AirPods might be perceived as inattentive or unwilling to engage in conversation—since headphones often signal disengagement—rather than being recognized as using them to assist with hearing difficulties.
Key Takeaway: Apple’s certification reflects innovation, but it must not be mistaken for substitution. While these earbuds may help in specific contexts or for specific individuals, they do not replace a professional hearing assessment or a regulated hearing aid. If you’re experiencing hearing difficulties, the safest first step is a comprehensive evaluation at a clinic like Echo Audiology.
Hearing Support for Low-Income Canadians — Options Already Exist!
One of the main arguments behind the push for over-the-counter (OTC) hearing aids is affordability. Hearing aids can be costly, especially without insurance, and many Canadians assume OTC devices offer the only low-cost alternative to professional care. But this is a misconception. In reality, Canada already offers several funding options to help people access hearing care, many of which include audiological assessments and professional support.
At Echo Audiology, we actively assists patients in navigating available funding programs and financing options, ensuring that each individual receives personalized care without sacrificing clinical safety for convenience.
Existing Programs:
- Ontario Ministry of Health Assistive Devices Program (ADP): Covers $500 per ear for eligible individuals
- Ontario Works and Ontario Disability Support Program (ODSP): Offer full funding for people on social assistance
- Veterans Affairs Canada (VAC): Program access for eligible/qualifying veterans
- Canadian Armed Forces (CAF): Program access for eligible/qualifying members
- Royal Canadian Mounted Police: Program access for eligible/qualifying members
- Non-Insured Health Benefits (NIHB): Covers First Nations and Inuit clients
- Workplace Safety & Insurance Board / Workers’ Compensation (WSIB): Coverage for work-related hearing issues for qualifying individuals
- Private Insurance: Many plans offer coverage for audiology services & hearing aids
Key takeaway: There are already multiple programs designed to make hearing support as accessible as possible. At Echo Audiology, we believe that every person deserves professional care that fits their hearing needs and financial situation. If you are unsure what programs you qualify for, contact our team for a confidential consultation, and take the first step toward better hearing, safely and affordably.
Why the Role of Audiologists Remains Unchanged and Essential
Yes, it’s true that OTC hearing aids and consumer tech like Apple’s “hearing aid mode” may offer added convenience, but they do not eliminate the need for licensed audiologists. In fact, as the hearing health landscape becomes more fragmented and complex, the role of audiologists has become more essential than ever.
Audiologists are not simply device providers; they are regulated healthcare professionals with specialized training in hearing science and rehabilitative care. They play a critical role in ensuring that your hearing loss is properly identified, managed, and treated in a safe and effective manner.
What an Audiologist Offers:
- Comprehensive case history analyses (e.g: identifying other contributing variables)
- Comprehensive hearing assessments (not just a tone test)
- Medical referrals when red flags (e.g., tumors, balance issues) are identified
- Custom device fitting, programming, and verification of real-ear measurement (REM)
- Ongoing care, adjustments, and support for years
Real-World Insights from Echo Audiology
- Our clinic regularly performs second opinion consultations for individuals dissatisfied with retail-bought devices or improperly programmed aids.
- We can verify OTC devices using real-ear measurement (REM), a step often skipped elsewhere, to assess their true value and limitations.
- In a lot of cases, further details within the case history analyses, assessment, verification, education and counselling, help provide insight into the problems reported; and the next possible steps to take.
Key Takeaway: No app or OTC device can replace the clinical insight, personalized care, and long-term partnership that an audiologist provides. Hearing health is deeply personal, and success depends not just on having the right technology, but also the right team to guide its use.
At Echo Audiology, that team is ready to support you with compassion, clinical care, and a commitment to your quality of life.
Why It All Starts with a Hearing Assessment
A broader trend toward consumer-driven health solutions encourages the rise of over-the-counter hearing aids and tech-enhanced alternatives like Apple’s AirPods Pro II. These innovations offer promise, especially in terms of accessibility and awareness. But in Canada, where safety and evidence-based care remain a top priority, they must be viewed with caution and context.
OTC hearing aids have their place, and they are not inherently bad. For some individuals with very mild, uncomplicated hearing loss, particularly those who are tech-savvy and proactive, they may offer short-term value. However, their use without a professional assessment or follow-up care introduces risks: misdiagnosis, over-amplification, device abandonment, and even delayed treatment of serious medical conditions.
That’s why Echo Audiology urges you to start with a comprehensive hearing evaluation, especially before trying any form of amplification, OTC or otherwise. Hearing difficulties and hearing loss are often gradual, complex, and specific to the individual. It deserves more than a one-size-fits-all product bought off a shelf or website.
The good news is that in Canada, there are already programs in place to help make hearing healthcare more accessible, including funding for professional hearing aids, full assessments, and ongoing support. From the Ontario Assistive Devices Program (ADP) to Veterans Affairs, from ODSP to private insurance, Echo Audiology’s team is committed to helping you access these resources and navigate the best options for your needs and budget.
Final Thoughts
Your hearing is closely tied to your relationships, safety, mental health, and overall quality of life. Choosing the right path forward requires more than buying a device; it means investing in your long-term well-being with the support of licensed professionals who understand your individual needs.
At Echo Audiology, we are here to make that journey clear, safe, and supportive, every step of the way.
Take the Next Step Toward Better Hearing
If you are curious about hearing aids or confused about OTC options, book a consultation with Echo Audiology today. We’ll walk you through your options, funding eligibility, and how to safely improve your hearing health.
Visit us online at www.echoaudiology.com or call our Orléans clinic directly to schedule your appointment.
