What is an OTC hearing aid?
Over-the-counter (OTC) hearing aids are air-conduction hearing aids that amplify sound into the ear canal and do not require surgical intervention or hearing healthcare professionals’ involvement. They are intended for adults (18 +) with perceived mild to moderate hearing loss and are considered direct-to-consumer (DTC) hearing devices. (FDA, 2022).
There are two categories of OTC hearing aids:
1. Self‑fitting devices: Settings are customized by the user, usually through a smartphone app. This may include an in‑app hearing screening or the option to enter results from a previously completed audiogram.
2. Pre‑set devices: These devices come with several pre‑programmed listening settings designed to accommodate different levels of mild to moderate hearing loss.
(SAC, 2025)
What is a prescription hearing aid?
Prescription hearing aids are devices that are custom‑fitted and programmed based on a comprehensive hearing assessment. They may be fitted for any degree of hearing loss and for clients of any age and are typically only available through regulated hearing health care providers. Although this differs from province to province, in Alberta, a prescription is not required to obtain these devices.
Who are OTC hearing aids for?
OTC hearing aids are intended for adults over the age of 18 who perceive that they have mild to moderate hearing loss. As it can be difficult to accurately identify the degree of hearing loss without formal testing, individuals who suspect hearing difficulties are encouraged to obtain a comprehensive hearing test. A hearing test can confirm whether hearing loss is present and determine its degree. Hearing health care professionals can also help identify which hearing devices, if any, are appropriate and whether medical assessment or intervention is required.
Can Children Use OTC Hearing Aids?
Over‑the‑counter (OTC) hearing aids are not intended for use by children or youth under 18 years of age. ACSLPA’s position is that OTC hearing aids are inappropriate for pediatric use due to the potential risk of harm (see ACSLPA’s Position Statement on OTC Hearing Aids and Pediatrics).
Individuals under 18 years of age, may be at higher risk of harm from over- or under-amplification. Inappropriate amplification could lead to further hearing damage and possible long-term negative developmental and academic outcomes. Children from birth to 18 years benefit from having a regulated audiologist fit and monitor prescription amplification.
How does an OTC hearing aid differ from a prescription hearing aid?
Below is a table outlining the key differences between prescription hearing aids and OTC hearing aids:
| Prescription Hearing Aids | OTC Hearing Aids | |
|---|---|---|
| Who they are for | Individuals of all ages | Adults 18 years and older |
| Degree of hearing loss | Any degree, from minimal to profound | Mild to moderate hearing loss only |
| Type of hearing loss | All types of hearing loss | Hearing loss without signs or symptoms that require medical assessment |
| How settings are chosen | Based on comprehensive diagnostic hearing assessments | Based on self‑report and/or screening hearing tests |
| Health professional involvement | Typically fitted and managed by a regulated hearing health care professional | Do not require professional involvement for fitting |
| Accuracy of amplification | Precisely matched to hearing needs using diagnostic results and verified output measurements | Estimated based on user input, screening results, or preset settings |
| User adjustment options | Users may make limited adjustments via an app; larger changes are supported by a hearing care professional | Users adjust settings independently using apps or physical controls |
| Technology level | Generally, more advanced and customizable | Typically, less advanced |
| Cost | Cost varies depending on the technology level and included professional services. The price often includes fitting, follow‑up care, and repairs. | Generally lower cost due to simpler technology and no bundled professional services. Follow‑up support and repairs may not be included. |
Why is it important to see a hearing health professional before getting a hearing aid?
A comprehensive hearing test is an important first step to ensure the best outcomes when using hearing aids. Testing helps confirm whether hearing loss is present, identify its type and severity, and determine which hearing device if any, is most appropriate.
Seeing a hearing health care professional also helps ensure there are no medical concerns that need attention before using a hearing aid. When professional assessment is removed from the diagnostic process, ear conditions that require medical treatment may be missed. If you notice a clear difference in hearing between ears, experience pain, or have drainage from the ear, it is important to see a physician or audiologist before using an over‑the‑counter hearing aid.
Red Flags: When NOT to Use an OTC Hearing Aid
OTC hearing aids are not appropriate for everyone. Some hearing and ear‑related symptoms may indicate an underlying medical condition that requires assessment by a physician or hearing health care professional before any type of hearing aid is used.
You should not use an OTC hearing aid and should seek professional assessment if you experience any of the following:
Sudden hearing loss
A rapid or unexplained change in hearing can be a medical emergency and requires prompt assessment. Using an OTC hearing aid may delay diagnosis and appropriate treatment.
Pain, drainage, or dizziness
Ear pain, fluid or discharge from the ear, or ongoing dizziness may be signs of infection or other medical conditions that should be treated before amplification is considered.
One ear worse than the other
A noticeable difference in hearing between ears may require further medical investigation. OTC hearing aids are intended for more symmetrical, uncomplicated hearing loss.
New or severe tinnitus
Sudden or bothersome ringing, buzzing, or other sounds in the ears should be evaluated by a hearing health care professional to rule out medical causes and determine appropriate management.
If you have any of these symptoms, it is important to see a physician or audiologist before using an OTC hearing aid.
Are OTC hearing aids safe to use?
In Canada, both OTC and prescription hearing aids are regulated by Health Canada. Manufacturers must obtain a medical device licence, confirming that their products meet federal safety, effectiveness, and quality standards under the Medical Devices Regulations. However, hearing aids are not tested to confirm exact amplification output, which means there is a risk of over‑ or under‑amplification.
It is also important to remember who these devices are designed for. OTC hearing aids are intended for adults over 18 years of age with perceived mild to moderate hearing loss. If you have concerns about an OTC hearing aid, the public is encouraged to report problems or incidents involving approved medical devices to Health Canada, either online or by calling 1‑800‑267‑9675. Concerns may include, but are not limited to, device malfunction, reduced effectiveness over time, difficulty of use, unclear instructions, or potential or actual harm.
Are OTC hearing aids available in Alberta?
Yes. Over‑the‑counter (OTC) hearing aids are available for sale in Alberta.
In Canada, both OTC and prescription hearing aids are regulated by Health Canada as Class II medical devices under the Canadian Medical Devices Regulations. This means manufacturers must obtain a medical device licence before their products can be sold in Canada. Health Canada has been licensing specific OTC hearing aids, and the public can search and verify whether a device has an active licence using Health Canada’s medical device licence database: Medical devices active licences search.
Approval by Health Canada does not determine whether a device will be sold in a particular province. Provincial and territorial governments are responsible for the organization and delivery of health care services and devices for their residents. In Alberta, OTC hearing aids are permitted for sale.
The Alberta College of Speech‑Language Pathologists and Audiologists (ACSLPA) does not regulate the sale of hearing devices or the vendors that sell them. Albertans are encouraged to research available devices and consider how they may meet their needs. Websites such as hearadvisor.com provide reviews and comparisons of different hearing devices and may be a helpful starting point.
What should I do next?
If you are thinking about using an over‑the‑counter (OTC) hearing aid, the following steps can help you make an informed and safe decision:
Consider a hearing test first
A hearing test is one of the best ways to understand what you are experiencing. It can confirm whether hearing loss is present, determine its degree, and identify whether there are any underlying medical concerns. Even if you decide to try an OTC hearing aid, having this information can help you choose the most appropriate option and avoid potential risks.
Review reputable sources
Not all information about hearing devices online is reliable. Look for guidance from trusted organizations, such as professional associations, government health agencies, or independent review sites that clearly explain how products are evaluated. This can help you understand what OTC hearing aids can and cannot do.
Check Health Canada licensing
Hearing aids sold in Canada must be licensed by Health Canada. Before purchasing an OTC hearing aid, confirm that the device has an active medical device licence. This helps ensure the product meets federal safety and quality requirements.
Talk to a hearing health professional if you are unsure
If you are uncertain about whether an OTC hearing aid is right for you, or if you have concerns about your hearing, a hearing health care professional can help. They can explain your test results, discuss device options, and advise whether further assessment or medical follow‑up is recommended.
Taking these steps can help you make a choice that best supports your hearing health.
Personal Sound Amplification Products (PSAPs) and hearables
It is important to distinguish OTC and prescription hearing aids from Personal Sound Amplification Products (PSAPs) and hearables. PSAPs are designed for individuals with normal hearing who want amplification in specific environments. Hearables are wearable consumer devices that may include sound amplification alongside other features, such as music streaming or fitness tracking. Unlike OTC and prescription hearing aids, PSAPs and hearables are not classified as medical devices and are not regulated. The Medical Devices Directorate (MDD) of Health Canada regulates both OTC and prescription hearing aids as Class II medical devices under the Canadian Medical Devices Regulation (MDR). Class II medical devices are considered to carry a moderate level of potential risk, and require a medical device licence before they can be sold in Canada.
Resources
Alberta College of Speech-Language Pathologists and Audiologists. (2025). Position Statement: Over-the-Counter (OTC) Hearing Aids and Pediatrics. https://www.acslpa.ca/wp-content/uploads/2025/10/Position-Statement-OTC-Hearing-Aids-and-Pediatrics-Final-Oct2025.pdf
Alberta College of Speech-Language Pathologists and Audiologists. (2025). Advisory Statement: Over-the-Counter (OTC) Hearing Aids and Professional Obligations. Advisory Statement: Over-the-Counter (OTC) Hearing Aids and Professional Obligations – Alberta College of Speech-Language Pathologists and Audiologists
American Academy of Audiology (n.d). Consumers and OTC Hearing Aids. FAQs Consumers Need to Know. Consumers and OTC Hearing Aids – American Academy of Audiology
Department of Justice Canada. (2025). Medical devices regulations SOR/98-282. https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/FullText.html
Health Canada. (2025, January 27). List of recognized standards for medical devices. Government of Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/standards/list-recognized.html
Speech-Language and Audiology Canada. (2025). SAC position paper on over-the-counter hearing aids in Canada. https://www.sac-oac.ca/wp-content/uploads/2025/07/2025-PP-AUD-OTC-Hearing-Aids-in-Canada-FINAL-EN.pdf
U.S. Food and Drug Administration. (2022). OTC hearing aids: what you should know. https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know