Over-the-Counter (OTC) Hearing Aids

What Are Over-the-Counter Hearing Aids?

Over-the-counter (OTC) hearing aids are a new category of hearing devices that consumers can purchase directly without visiting a hearing health professional, without a prescription and even without a hearing test. These devices are designed to amplify sounds for adults with perceived mild to moderate hearing loss, allowing them to better listen, communicate, and participate in daily activities.

Unlike prescription hearing aids, which require professional fitting and adjustment, OTC hearing aids are designed for self-fitting and user control. OTC hearing aids are regulated as medical devices by the U.S. Food and Drug Administration (FDA) and can be bought in stores or online. However, they are still unavailable for sale in Canada.

How Do OTC Hearing Aids Differ from Prescription Hearing Aids?

While both OTC and prescription hearing aids serve the fundamental purpose of amplifying sound, they differ in several key aspects:​

1. Customization and Fitting:

   • Prescription Hearing Aids: These devices are customized to an individual's specific hearing loss, determined through a complete audiological assessments (see this article for more information).. An audiologist or audioprosthesist programs the device to match the user's hearing needs, ensuring best performance.​

   • OTC Hearing Aids: OTC devices are generally designed with a one-size-fits-all approach, offering limited customization. Most models allow users to adjust settings manually via smartphone apps, but they lack the personalized programming provided by hearing professionals.​

2. Professional Involvement:

   • Prescription Hearing Aids: The process involves consultations with audiologists who assess hearing, recommend suitable devices, provide fittings, and offer ongoing support and adjustments.​ In Quebec, only audioprosthesists are allowed to dispense the hearing aid.

   • OTC Hearing Aids: These devices are intended for self-fitting, with users responsible for selecting and adjusting the device without professional assistance (usually through a smartphone app). This autonomy can be beneficial for some but may pose challenges for others unfamiliar with hearing technology.​

3. Regulatory Oversight and Quality Assurance:

   • Prescription Hearing Aids: Subject to strict regulatory standards, these devices undergo rigorous testing for safety, efficacy, and quality.​

   • OTC Hearing Aids: Regulatory oversight varies by country. In the U.S., the Food and Drug Administration (FDA) has established guidelines to ensure safety and effectiveness. In Canada, specific regulations for OTC hearing aids are currently lacking, and therefore they sale is not permitted.

Pros and Cons of OTC Hearing Aids

Pros:

• Accessibility: Easier to purchase without the need for medical appointments.​

• Affordability: Generally less expensive than prescription models, making hearing amplification more attainable.​

• Convenience: Immediate availability allows users to address hearing concerns promptly.​

Cons:

• Limited Customization: May not adequately address individual hearing loss profiles, potentially leading to suboptimal performance.

• Lack of Professional Support: Without audiologist involvement, users may struggle with proper fitting, adjustments, and troubleshooting.​ Self-fitting may not be as precise as professional fitting, again potentially leading to suboptimal performance.

• Quality Variability: Inconsistent regulatory oversight can result in varying product quality, especially in regions without established guidelines.​

Who Are OTC Hearing Aids For?

OTC hearing aids are designed for adults with perceived mild to moderate hearing loss. They are not intended for children or adults with severe hearing loss or significant difficulty hearing.

Ideal candidates for OTC hearing aids are:

• Adults who have noticed some hearing difficulties but have not yet sought professional help.

• Individuals comfortable with technology and willing to self-manage their hearing devices.

• Those looking for a more affordable and accessible hearing solution.

• People who want to try hearing amplification without committing to prescription hearing aids.

It's important to note that OTC hearing aids may not be suitable for everyone with hearing loss. If you have more severe hearing loss, experience sudden hearing loss, or have other ear-related symptoms, it's crucial to consult with a hearing health professional

Top 5 OTC Hearing Aid Brands and Their Costs

These recommendations are based on my personal research from articles and reviews that I have summarized here. They have not been personally tested, as they are not yet available for sale in Canada. Prices are in US dollars.

1. Jabra Enhance Plus:

   • Price: Approximately $799 per pair.​

   • Features: Compact design, Bluetooth connectivity, and user-friendly app for adjustments.​

    
2. Lexie B2 Powered by Bose:

   • Price: Around $899 per pair.​

   • Features: Self-fitting technology, directional microphones, and noise reduction capabilities.​

    
3. Sony CRE-C10:

   • Price: Approximately $999 per pair.​

   • Features: Discreet in-ear design, customizable settings via smartphone app, and rechargeable batteries.​

    
4. Eargo 6:

   • Price: Around $2,950 per pair.​

   • Features: Virtually invisible design, rechargeable, and advanced sound processing with noise reduction.​

    
5. Sennheiser All-Day Clear:
   • Price: Approximately $1,400 per pair.​
   • Features: Comfortable fit, clear sound quality, and Bluetooth streaming capabilities.​

Canadian Regulations Regarding OTC Hearing Aids

Currently, OTC hearing aids are not approved for sale in Canada. In Canada, hearing aids are classified as Class II medical devices and require a prescription from a qualified hearing health professional. The sale and distribution of hearing aids are regulated by Health Canada under the Medical Devices Regulations. Health Canada regulates hearing aids as medical devices, and provincial laws often restrict their sale to registered health professionals. This is the case in Quebec for example, where only audioprosthesist (and not audiologists) are allowed to dispense hearing aids. 

Canadians seeking such devices must currently obtain them from international sources, which may not provide the same consumer protections and quality assurances.

American Regulations Regarding OTC Hearing Aids

The FDA established regulations for OTC hearing aids in August 2022, following the Over-the-Counter Hearing Aid Act of 2017. These regulations ensure that OTC devices are safe and effective for people with perceived mild to moderate hearing loss. Key aspects of the regulations include:

• Setting standards for package labels to help buyers understand OTC hearing aids and who might benefit from them.

• Establishing safety and effectiveness criteria.

• Defining the new category of OTC hearing aids as devices using air conduction to improve hearing among adults with mild to moderate hearing impairment.

• Requiring the U.S. Department of Health and Human Services to document adverse events associated with OTC hearing aids.

The Future of OTC Hearing Aids in Canada

As of March 2025, there are no immediate plans to introduce OTC hearing aids in Canada. However, the landscape of hearing healthcare is evolving globally, and Canada may consider changes in the future. I believe that  believe Canada will eventually follow the U.S. lead in introducing OTC hearing aids, though the timeline remains uncertain.

While OTC hearing aids are not yet available in Canada, there are signs of potential change. In January 2025, Health Canada approved Apple's AirPods Pro Firmware Module and Hearing Aid Feature iPhone App as Class II medical devices. This suggests a potential shift towards more accessible hearing technology.

Factors that could influence future regulations include:

• The success and impact of OTC hearing aids in the United States.

• Advocacy from consumer groups and hearing health organizations.

• Evolving technology and safety standards in hearing aid devices.

• Efforts to improve accessibility and affordability of hearing healthcare.

While changes may occur in the future, it's important for Canadians to continue working with hearing health professionals to ensure proper diagnosis, fitting, and ongoing care for their hearing needs. Any potential introduction of OTC hearing aids in Canada would likely involve careful consideration of safety, efficacy, and the overall impact on hearing healthcare delivery.