Entering the era of OTC hearing aids

According to a report released by the World Health Organization (WHO) in 2021, the number of people aged 60 and above with hearing loss has exceeded 65% worldwide. Age-related hearing loss is the third most common senile disease in the world after arthritis and hypertension. Other studies have shown that hearing loss affects 83% of people aged 70 and above.

Age-related hearing loss cannot be cured by drugs and surgery. Hearing aids should theoretically become the most commonly used intervention method. Traditionally, hearing aids are regarded as medical devices, and their purchase process usually includes professional hearing tests, customized services from fitters, and subsequent adjustments and maintenance. This series of processes is not only time-consuming, but also expensive.

With the development of technology and the increase in consumer demand, in 2017, the U.S. Food and Drug Administration (FDA) began to explore the regulatory framework for OTC hearing aids, aiming to allow certain types of hearing aids to be sold directly to consumers without professional fitting through new classifications. This policy will officially take effect in 2022, marking the official opening of the OTC hearing aid market in the United States and even the world.

The introduction of over-the-counter hearing aids has played a positive role in market development, giving consumers greater autonomy, and its convenience and economy are more conducive to increasing the popularity of hearing aids.

What are OTC hearing aids?

OTC hearing aids refer to "Over-the-Counter" hearing aids, which are devices designed to enhance hearing and can be purchased directly in retail stores or online without prescriptions or advice from hearing professionals. Compared with traditional prescription hearing aids, OTC hearing aids are generally cheaper and more accessible.

The concept of OTC hearing aids originated in the United States. On December 7, 2016, the U.S. FDA (Food and Drug Administration) announced that in order to enable hearing-impaired patients to get the help of hearing aids better, more conveniently and more economically, they decided to take an important step and no longer require individuals aged 18 and over to undergo a medical evaluation or sign a waiver statement before purchasing a hearing aid.

In October 2021, the U.S. FDA formally proposed the establishment of a new OTC hearing aid category, allowing hearing aids to be sold directly to consumers in stores or online without hearing tests or hearing experts.

The formulation of this new rule originated in 2017 and has gone through years of consultation and the release of draft regulations. In the end, the new standard was approved and will have a significant impact on the entire hearing aids industry. This move means that more people can get and use hearing aids more conveniently, lowering the threshold for purchasing and using hearing aids.

OTC hearing aids can be purchased online or in pharmacies. The emergence of OTC hearing aids provides a more convenient way for hearing-impaired people to choose and fit, reduces the economic burden, and promotes the development of related services. This has a positive impact on increasing the popularity of hearing aids and promoting hearing health.

Are OTC hearing aids safe?

Over-the-counter hearing aids are sold directly to users, which means that users can adjust the volume of the sound based on their own listening experience through simple learning (reading instructions, telephone consultation, etc.), without the need for professional equipment to evaluate the effect, and without the help of professionals to debug. Some hearing aids also allow some parameters to be adjusted through mobile phone apps or buttons on the hearing aids to better meet their own hearing needs.

OTC hearing aids generally have pre-set parameters to meet most of the daily hearing needs of hearing-impaired users. In addition, the FDA has also proposed setting a maximum volume limit for OTC hearing aids to prevent hearing damage caused by excessive sound amplification. In addition, corresponding requirements are put forward for sound processing, amplification and transmission speed, and the depth of ear placement.

Therefore, OTC hearing aids are as safe and reliable as headphones, earplugs, and personal sound amplification systems on the market.

Advantages of OTC hearing aids

OTC hearing aids have several distinct advantages over traditional prescription hearing aids.


Low price: OTC hearing aids are generally cheaper than traditional prescription hearing aids, making them more affordable for more people, especially those without health insurance or medical subsidies.

Cost savings: Since there is no need for frequent medical visits or professional adjustments, using OTC hearing aids can save costs incurred by medical services and expert adjustments.

Convenience and accessibility

Self-purchase: Users can purchase OTC hearing aids directly from pharmacies, online or other retailers without waiting for a doctor's prescription, saving time and administrative procedures.

Flexibility: Without the need to make an appointment with a specialist, users can purchase and start using hearing aids immediately when they need them, reducing waiting time and barriers to medical treatment.

Technological advances and features

Modern technology: Many OTC hearing aids are equipped with advanced digital signal processing technology, including noise suppression, multi-channel adjustment, smart connectivity and other functions, which improves the user's hearing experience.

Personalized settings: Some OTC hearing aids allow users to adjust settings by themselves through applications or control devices, and personalize them according to their own hearing needs, which increases the comfort and effectiveness of use.

Trial and refund policies

Trial period: Many OTC hearing aid brands offer a trial period, giving users ample time to test and adapt to the hearing aids to ensure that they meet their personal needs.

Refund guarantee: There is usually a refund policy. If the user is not satisfied or cannot adapt to the OTC hearing aid, they can return the product within a certain period of time and get a refund, which reduces the risk of purchase.

Eliminate some barriers to traditional hearing aids

Reduce social barriers: Traditional hearing aids may be subject to certain social barriers or psychological barriers, and the use of hearing aids is considered a symbol of old age. The emergence of OTC hearing aids can help eliminate these prejudices and enable more people to accept and use hearing aids.

Overall, OTC hearing aids provide a more convenient and affordable solution for many people with hearing needs by reducing costs, improving accessibility, integrating advanced technology, and enhancing user control.

However, individuals still need to consider their own hearing conditions and needs when choosing hearing aids, as well as the technical limitations of OTC hearing aids and the limitations of personalized adjustments.

Who are OTC hearing aids suitable for?

The US FDA stipulates that OTC hearing aids are only suitable for adults aged 18 and above with mild to moderate hearing loss. For those with severe hearing loss or hearing loss under the age of 18, a hearing test must still be done first, and then the hearing aid must be adjusted and selected by the fitter.

The following are some situations and people who are suitable for choosing OTC hearing aids.

Mild to moderate hearing loss

OTC hearing aids are generally designed for people with mild to moderate hearing loss. These hearing aids may not be suitable for treating more severe hearing loss, as these situations may require more precise adjustments and customized settings.

Cost-sensitive consumers

Those who want to save money and look for affordable solutions. Traditional prescription hearing aids may require expensive professional service fees, while OTC hearing aids are generally more affordable.

Technically proficient and autonomous individuals

People who have a certain level of technical ability and willingness to adjust and manage hearing aids on their own. OTC hearing aids offer some self-setting and adjustment features, so users need to have a certain level of technical proficiency and be aware of their hearing condition.

People who need OTC hearing aids

No complex hearing needs

Hearing aids are needed mainly to improve conversation and sound understanding in daily life, rather than to deal with complex listening environments or professional listening needs.

Willing to try and adjust

Willing to try and adjust after purchase to ensure that OTC hearing aids are suitable for their hearing needs. Some OTC hearing aids brands offer trial periods and money-back guarantees, allowing users to have sufficient testing and evaluation time before purchasing.

Although OTC hearing aids have their obvious advantages and applicable situations, for some people with the following characteristics, it may be more suitable to choose traditional prescription hearing aids.

Severe hearing loss: Requires more advanced technical support and professional adjustment.

Complex listening environment needs: Such as noisy environments, music performances or meetings.

Special ear anatomy: Custom hearing aids may be required to ensure proper fit and comfort.

Long-term follow-up and adjustment are required: Children and elderly people with severe hearing loss, for example, require regular professional services and monitoring.

Therefore, when choosing a hearing aid, it is recommended to consider comprehensively based on personal hearing condition, lifestyle, technical ability, and expectations for hearing assistance in order to choose the solution that best suits their needs.

How to choose the right OTC hearing aid?

There are several key factors to consider when choosing the right OTC hearing aids to ensure that they can effectively improve hearing and is consistent with personal lifestyle and needs. Here are a few steps and considerations for choosing a right OTC hearing aid.

  1. Understand your hearing condition

Before choosing a hearing aid, it is best to have a professional hearing assessment. Although OTC hearing aids do not require a doctor's prescription, understanding your degree and type of hearing loss (such as mild, moderate) can help you choose the right type and function of hearing aids.

  1. Choose the right type of hearing aids

Earplug (ear canal): This type of hearing aid is inserted directly into the ear canal and is relatively concealed, like CHOSGO SmartU Rechargeable OTC Hearing Aids.

Behind-the-ear: Behind-the-ear hearing aids are larger and are suitable for more advanced hearing loss.

Bone conduction hearing aids: They are suitable for certain types of hearing loss, and they transmit sound by vibrating bones.

  1. Consider the technical features and functions of the hearing aid

Digital signal processing: Modern OTC hearing aids usually have digital signal processing technology, which can effectively suppress background noise and improve speech clarity.

Smart connection: Some hearing aids can connect to smartphones or other devices via Bluetooth, like CHOSGO K23 Bluetooth OTC Hearing Aids, allowing users to adjust settings, answer calls, etc. through applications.

Battery life: Understand the battery life and charging method of the hearing aid to ensure that it meets the needs of your daily use.

  1. Trial and refund policy

Most OTC hearing aid brands offer a trial period and refund policy, which gives users the opportunity to actually test the effectiveness and comfort of the hearing aid before purchasing. Make sure you understand the length of the trial period and the refund conditions.

  1. User experience and reviews

Before choosing hearing aids, you can check the reviews of consumers and experts to understand the pros and cons of different brands and models, as well as the actual experience of using them.

  1. Adaptability and adjustment

Choose hearing aids with certain adjustment and personalized setting options so that they can be adjusted according to your personal hearing needs and comfort.

  1. Cost and warranty

Consider the cost of the hearing aid and the warranty period. Although OTC hearing aids are generally cheaper than traditional hearing aids, they should also be of reliable quality and have acceptable after-sales service support.

Although users can buy and wear OTC hearing aids in stores or online, there are still some potential risks and problems, especially for hearing-impaired people with certain special circumstances. Here are some situations to pay attention to.

The wearing effect of OTC hearing aids may be unpredictable

Hearing aids purchased by themselves may not meet individual hearing needs and special circumstances. In the case of improper adjustment or unsuitable hearing aids, the expected hearing improvement effect may not be achieved, resulting in the user's perception and satisfaction with the hearing aid being affected.

Not suitable for specific hearing-impaired people

OTC hearing aids are generally not suitable for age groups under 18 years old and people with severe and above hearing loss. These people usually need more professional hearing assessment and matching to get hearing aids that are more suitable for their specific needs.

Possible delays in the treatment of special hearing problems

For some special cases, such as accidental unilateral hearing loss, sudden deafness, conductive hearing loss, etc., directly purchasing OTC hearing aids may not solve the root problem and may delay timely treatment or intervention. These cases may require evaluation and treatment by a doctor or hearing specialist.

Therefore, for hearing-impaired people in special cases, or those who want more professional hearing aid solutions, we still recommend consulting a professional hearing center or hearing specialist for evaluation and matching. This ensures the safety and effectiveness of selecting and using hearing aids, and avoids potential problems and delayed treatment.

Have a OTC hearing aid here.