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What You Should Know About the FDA’s Final Regulations for Over-the-Counter Hearing Aids

Written by OrkaOct 10, 2022 - 5 min read


The U.S Food and Drug Administration (FDA) has finalized regulations on access to Over-the-Counter (OTC) hearing aids, in hopes of helping people purchase affordable hearing aids in an more efficient way.

OTC Hearing Aids: Are They a Good Fit for You?

Over-the-Counter hearing aids are a new category of hearing aids that consumers can now purchase through online platforms and traditional retail stores, without necessarily having an audiologist’s prescription. The category will serve people with mild to moderate hearing loss, who can purchase and use the OTC hearing aids without a professional’s supervision. This means that OTC hearing aids will not only improve access for consumers to quality devices at better prices, but also push forward innovation and growth in the hearing industry.

The Decision to Use OTC Hearing Aids

The FDA’s regulations will allow people with mild to moderate hearing loss to purchase OTC hearing aids. To decide whether Over-the-Counter hearing aids are a suitable option, it is recommended to first determine one’s level of hearing loss. People with severe hearing loss still have to seek professional help concerning their hearing loss.

The FDA’s final regulations ensure that a larger number of OTC hearing aid manufacturers will be available in the market. In effect, customers will have more hearing aid options to choose from. For example, the award-winning and FDA-approved Orka One is available for online purchase and is competitively positioned against traditional hearing aids.


For a quality hearing aid that is within the reach of more people, the rechargeable hearing aid comes equipped with features such as Bluetooth® 5.0 pairing, music streaming, automatic call switching and Artificial Intelligence (AI) DeNoise technology. Additional useful features in Orka One include a long-lasting battery that, with a single charge, lasts up to 10 hours on the AI DeNoise mode and 7 hours when listening to music or on calls; sweat and water resistance highly rated at IPX5; charging case that works with a Type-C connector.

Similar features are available in high-end traditional hearing aids, but at a higher cost, which is out of reach for most people in need of quality devices.

As the FDA has provided the rules around the marketing, sale and distribution of OTC hearing aids, it means that customers will now have access to such affordable and feature-packed OTC hearing aids. It also means that customers have the option of purchasing low-priced and high-quality Over-the-Counter hearing aids over the $5000-a-pair high-end hearing aids.

The adjustment of device features and optimization for effective performance requires that the user is ready to self-manage the device. So, if one is also comfortable with using tech gadgets, they will find the new category of hearing aids friendly to use and easy to operate.

The Benefits of Using OTC Hearing Aids To Manage Hearing Loss

The statistics show that the use of hearing aids to manage hearing loss among people with mild to moderate hearing loss can help to avoid the socially disabling effect of mild to moderate hearing loss.

As the FDA’s rule brings hearing aids within the reach of most people in need, OTC hearing aids will prove a suitable intervention method for the majority of people with mild to moderate hearing loss. If you are looking for a way of dealing with the problems associated with mild to moderate hearing loss, then the new category of hearing aids will prove a good fit for you.

How FDA's regulation Will Affect Consumers

By finalizing the regulations, and in effect promoting the sale of Over-the-Counter hearing aids, the FDA has paved the way for the elimination of barriers posed by the dependence on traditional hearing aids.

The regulatory process will benefit customers in several ways. These include the promotion of fair pricing practices, encouragement of innovation in the industry and the availability of reliable and effective post-purchase services.

A closer analysis of the benefits to customers will show that the FDA’s new regulations on OTC hearing aids are a game changer in the hearing aids industry.

1. Improved Access to Quality Devices at Fair Prices

According to data from the National Institute on Deafness and Other Communication Disorders, more than 37 million (about 15%) Americans aged 18 years and above experience hearing problems. The statistics also show that more than 28 million citizens could benefit from the use of hearing aids.

The evidence emerging from the statistics shows that even though a large number of people could benefit from the use of quality hearing aids, they lack access to the devices. The failure to access hearing aids that have the combination of a comfortable fit and high sound clarity makes the FDA’s regulations necessary.


More people continue to miss out on the opportunity to acquire hearing aids that meet their needs. This remains the situation despite most of the people being over 18 years of age, which is the age limit set by the FDA.

It is in recognition of the quality and affordability of Over-the-Counter hearing aids that the FDA has set out the final regulations.

2. Encourage Growth of Innovation in the Industry

As the FDA rules allow the distribution of Over-the-Counter hearing aids from different manufacturers, innovation is set to grow. Innovation in the hearing aids industry is taking the direction of providing customer-focused solutions.

The range of innovative OTC hearing aids provides customers with the ability to personalize the final product according to their needs. Customers do not have to wait a long time to get feedback on their device preferences.

As one hearing aids manufacturer provides a high level of quality devices and services, other manufacturers will follow suit and incorporate additional innovative ideas in their products.

According to Grand View Research, a U.S based market research and consulting company, smart linked hearing aids are setting the pace in competition and improved customer service for the hearing aids market. As the research company summarizes its findings on the U.S hearing aids market, it offers useful insights on the growth of different types of hearing aids.

Data Intelo, a research company operating in the United States, also published its findings on the projected growth in demand for Receiver-In-Canal [RIC] hearing aids. The statistics show that RIC hearing aids will grow at a compound annual growth rate of 4% for the period 2020-2030. The United States will have a 39% share of the market and take the top position in the demand for hearing aids. Among the features driving demand for RIC hearing aids is the attractive and improved design that makes the devices easy to fit.

An example of the benefits one gets from the smart linked, Receiver-In-Canal hearing aids is Orka One’s advanced compatibility with any Bluetooth®-enabled device. Orka One has improved compatibility that lets users easily connect to Android, iOS, tablets, TVs and laptops. This increases the user’s connectivity with the social environment and ensures they remain updated with the experiences that matter to them.

The result of having advanced and useful features in hearing aids is growth for the whole industry and a growing list of benefits for the high number of people in need of quality OTC hearing aids.

3. Availability of Efficient Post-Purchase Services

Access to post-purchase services in the form of professional advice and support is available with the Over-the-Counter hearing aids. Professional support is usually missing in the case of cheaper personal sound amplifiers that are a one-off purchase.

The fear of missing out on professional advice from an audiologist leaves most people hesitant of purchasing Over-the-Counter hearing aids. The customers’ worry escalates further as the FDA’s rules will not necessarily require the involvement of hearing professionals for the purchase of OTC hearing aids.

Despite the possibility of losing out on professional advice through OTC hearing aids being real, the best products in the market will come with a remote care package. One can remotely access audiologist services as part of their purchase.

The best brands in the market offer a remote care package that ensures customers have the best experience in ways such as audiologist-quality adjustment online. This means one can skip the hassle of clinic visits and waiting rooms by having their consultation conducted online. Orka One’s free offer of a professional first fit coupled with two professional consultations is the first of its kind in the market.

In appreciation of teleaudiology and its application in providing remote care services, one can have confidence in the quality of professional advice they receive through remote consultations. And if there is something to learn from the coronavirus pandemic, it is that online interactions are here to stay.

The Need for Regulation

An increase in the adoption of OTC hearing aids in the market raises concerns about the safety and effectiveness of the devices. To ensure that people in need of hearing aids only access safe and reliable products, the FDA has formulated the rules guiding the use of the devices.

By promoting safety in the use of Over-the-Counter hearing aids, the government ensures that the users can experience social participation. The lack of social participation arises from the stigma arising from the loss of hearing ability and the inability to cope with the demands of interpersonal relationships.


As people purchase and use FDA-approved OTC hearing aids, they have the assurance of experiencing an improved quality of life.

Perhaps the testimony of a user who has experienced the direct benefits of OTC hearing aids can best capture the social benefits linked to access to quality hearing aids.

“The #hearingaids provide me back what I missed for several years, namely the ability to jump in any conversations and not having to guess what the people are saying.” Jene-Rene, Orka One user*.*

Another user comments about his experience using Over-the-Counter hearing aids and the benefits experienced so far.

“I love how much better I can hear bird songs, and how rich and complex they are.” Paul, Orka One User*.*

Based on user feedback, regulation emerges as an important part of ensuring that the quality and affordable OTC hearing aids remain available to the users that need them.

Orka One’s Customized and Comprehensive User Service

As a leading and award-winning brand in the hearing aids market, Orka One stands out from other brands in the market with a customized and comprehensive user service, which includes first fit and two follow-up consultations.

Added to the outstanding user service, Orka One’s human-centered design makes it one of the most preferred hearing aids currently available in the market.

The brand addresses some of the misconceptions and fears that customers have concerning hearing aid brands in the market.

ProblemOrka One's Solution
  1. A user risks improper treatment of their hearing loss.
Orka provides a remote care package that allows users to consult professionals as they use the hearing aids.
  1. Lack of guarantee that the OTC hearing aids will have good programing.
Audiology quality adjustment is available and the entire process is done online.
  1. OTC hearing aids might not actually reduce the overall cost of hearing aids.
Orka One costs a fraction of the traditional hearing aids without a compromise on the quality. Users that lack insurance cover while using traditional hearing aids have the improved option of Over-the-Counter hearing aids.
  1. OTC hearing aids might lack favourable repair and replacement terms.
Offer comes with no obligation and free try-on to ensure high-level customer satisfaction. In addition, Orka One has a 2-year warranty (in case of accidental damages to the device) and a 45-day money back guarantee.

Orka One provides you with an opportunity to experience a superior quality of comfortable-to-wear hearing aids, along with and an industry-leading customer service experience.

All content and information on this website is for informal and educational purposes only, nothing contained herein shall constitute medical advice, and does not establish any patient-client relationship by your use and access of this blog.
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