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OTC Hearing Aids,
Make Things Easier

In recent years, Over-the-Counter (OTC) hearing aids have emerged as a game-changer, providing individuals with an accessible and affordable way to enhance their hearing experience.

What Is
OTC Hearing Aid

Over-the-Counter hearing aids are designed to empower individuals with mild to moderate hearing loss to take control of their auditory well-being. Unlike traditional hearing aids, which require a prescription and professional fitting, OTC hearing aids are available directly to consumers without the need for a middleman. This revolutionary approach allows users to make informed choices about their hearing health and enjoy the benefits of improved hearing on their terms.

Why Choose
OTC Hearing Aid?

Accessibility: OTC hearing aids put the power back in your hands, eliminating the need for multiple visits to healthcare professionals. This accessibility ensures that you can start your journey to better hearing without unnecessary delays.

Affordability: Traditional hearing aids can be expensive, often including costs associated with professional consultations and fittings. OTC hearing aids offer a cost-effective alternative, allowing you to invest directly in the device that meets your needs, reducing financial barriers to improved hearing.

Customization: OTC hearing aids are designed with user-friendly controls, allowing you to personalize your listening experience. Adjustments for volume, background noise, and other settings can be made easily, putting you in control of your auditory environment.

Over-the-counter vs. prescription

When comparing traditional prescription hearing aids to Over-the-Counter (OTC) hearing aids, several key factors influence the choice between the two. Prescription hearing aids necessitate multiple appointments and professional fittings, contributing to a higher overall cost due to the associated professional services. In contrast, OTC hearing aids offer easy accessibility without the need for prescriptions or fittings, making them more affordable and available in pharmacies, retailers, and online.

Customization and personalization play a crucial role in the decision-making process. Prescription hearing aids excel in being highly customizable to individual needs, providing tailored solutions. On the other hand, OTC hearing aids offer user-friendly controls for basic adjustments but may not reach the same level of personalization as their prescription counterparts.

The initial adaptation and learning curve also differ between the two options. Prescription hearing aids come with a learning curve during the initial adaptation period, while OTC hearing aids are designed for ease of use, minimizing the learning curve for users.

Lastly, professional support varies significantly. Prescription hearing aids come with ongoing professional support and maintenance services, ensuring users receive necessary assistance. In contrast, OTC hearing aids offer limited professional support, although remote assistance may be available to aid users in managing their devices effectively. The choice between prescription and OTC hearing aids ultimately depends on individual preferences, budget constraints, and the level of customization and ongoing support desired.

How to Choose the right OTC hearing aid?


Assess Your Hearing Needs

Begin by understanding the degree and specific situations of your hearing loss. OTC hearing aids are typically suitable for mild to moderate hearing loss.


Evaluate Features and Controls

Assess the controls and features offered by each device. Ensure the OTC hearing aid has adjustable settings for volume, tone, and noise reduction to meet your specific preferences.


Comfort and Design

Choose a device with a comfortable and discreet design that aligns with your lifestyle. Consider factors like physical comfort during extended use and the visibility of the device.


Budget Considerations

Determine your budget, including not only the device cost but also any additional accessories or services. Compare prices across different brands to find an OTC hearing aid that offers the best value for your investment.

The Origin of OTC Hearing Aids

2017 from the White House

In 2016, the President’s Council of Advisors on Science and Technology (PCAST) addressed the challenges of age-related hearing loss, highlighting the expensive nature of hearing aids and the barriers in the current acquisition process. PCAST proposed that simple changes to the Food and Drug Administration (FDA) regulations could significantly improve the accessibility of hearing aids without compromising the safety of those with hearing impairments.


PCAST recommended establishing a basic air-conduction hearing aid (non-surgical) suitable for mild to moderate age-related hearing loss. Moreover, they suggested that this type of hearing aid should be available over the counter (OTC), allowing for purchase in stores or online without the need for consultation with certified fitting specialists. PCAST also proposed self-diagnostic and self-adjustment tests for users, empowering them to self-assess, manage, and monitor their hearing needs.


Echoing PCAST’s sentiments, the United States National Academy of Sciences (NAS) advocated for strengthening consumers’ and patients’ ability to navigate hearing health care systems. They aimed to improve access to hearing care for underserved populations and introduce FDA-approved OTC hearing aids for easy over-the-counter purchase.


In response to these recommendations, President Trump signed the Over-the-Counter Hearing Aid Act into law in 2017. This bipartisan legislation mandated the FDA to formulate regulations supporting OTC sales of hearing aids for mild to moderate hearing loss, revolutionizing the hearing aid industry. The act eliminated the need for a medical waiver, enabling individuals with mild to moderate hearing loss to access hearing aids without bureaucratic hurdles.


To counter arguments from PCAST and NAS, hearing care experts emphasize the positive benefits of existing hearing aid acquisition models. Numerous studies show that in-person fitting services provide superior results compared to online alternatives, emphasizing the value of face-to-face assistance. The presence of significant others during the fitting process also yields positive outcomes, with a higher percentage of individuals choosing to wear hearing aids when accompanied by important persons in their lives.


Since the official implementation of the Act in October 2022, hearing aid products can now claim to address hearing loss specified under FD&C Act Section 520(q) and be marketed as OTC hearing aids. While hearing aids remain regulated devices, sales must comply with federal and state requirements.


The enactment of this legislation points towards a potential future of innovative developments in the hearing aid industry. Early access to hearing aids helps mitigate the health risks associated with hearing loss and reduces the societal welfare costs. The use of hearing aids significantly improves the quality of life for those with acquired hearing loss, underscoring the importance of early and continuous use for post-lingual hearing-impaired individuals (Lin, 2019). As the law takes effect, it sets the stage for a new era of positive change, allowing individuals with hearing loss to proactively manage their hearing health and well-being. Mimitakara, as a qualified provider of OTC hearing aids, stands ready to contribute to this transformative journey, offering affordable and accessible solutions for a thriving OTC hearing aid community.


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