Two woman in a store, one purchasing over the couter hearing aids from the other.

Over-The-Counter Hearing Aids: What You Need To Know

Published: December 10, 2021

Updated: November 1, 2022

Over-the-counter, or OTC, hearing aids have been approved by the FDA and have been available for purchase since October 16, 2022. This new category of hearing aids is set to fill a big need in the market. There are an estimated 48 million Americans who suffer from hearing loss, which can have a devastating impact on a person’s well-being and quality of life. However, most Americans cannot afford a hearing aid to relieve their hearing loss as their health insurance generally does not cover them fully.

Hearing aids, though, are one of the best ways to assist those with hearing loss and the introduction of OTC hearing aids allows a large number of those impacted by hearing loss to get the help they need. The FDA Reauthorization Act of 2017 propelled OTC hearing aids to become available in brick-and-mortar stores thanks to an act that was mandated by Senator Elizabeth Warren and Senator Chuck Grassley. President Joe Biden then issued an Executive Order that saw the FDA create a new classification of OTC hearing aids, allowing those parties affected to purchase OTC hearing aids.

What are over-the-counter hearing aids?

Over-the-counter (OTC) hearing aids are designed to treat those suffering from mild-to-moderate hearing loss without the need for an examination, prescription, or audiologist fitting, while still receiving quality, affordable hearing aids. An OTC hearing aid is beneficial because it extends the accessibility of hearing aids, as consumers can simply purchase them directly from retailers. 

Why are over-the-counter hearing aids so important?

OTC hearing aids are important because they make quality hearing aids an affordable and accessible option to the millions of people in the US who need them. They lower barriers to hearing health accessibility and will ensure that quality devices are available across the country.

Here’s what you need to know about OTC hearing aids.


OTC hearing aids feature some of the same technology that you would find in prescriptionhearing aids, with the only difference being that you can now acquire them without a prescription from a healthcare provider. In fact, OTC hearing aids can even include features like Bluetooth connectivity, as well as app functionality, for greater customization over your hearing aid. 


OTC hearing aids also offer consumers enhanced control and customizability, in order to meet their individual needs. Some OTC hearing aids, such as those offered by Lexie Hearing, offer self-assessments and self-tuning, in order to provide you with the best possible functionality. OTC hearing aids could also be customized through the app for various sound profiles based on different environments.

FDA Regulated

OTC hearing aids will still be regulated by the Federal Drug Administration with clear labeling requirements related to use, safety, as well as efficacy, in order to ensure OTC hearing aids are safe to use. 


OTC hearing aids are far more accessible than prescriptionhearing aids because there is no requirement for a prescription from a healthcare professional. Thanks to this accessibility, a much larger number of people living with hearing loss can receive treatment through OTC hearing aids, as they are easily purchasable directly from retailers across the United States. 


Alongside accessibility is the affordability of OTC hearing aids when compared to prescription hearing aids. Not only are prescription hearing aids more expensive than their OTC counterparts, a cost not generally covered by health insurance. They also accrue high medical bills because of regular visits with healthcare professionals. OTC hearing aids remove this financial barrier and offer a more affordable option for obtaining hearing aids.


Which hearing devices options are available now?


Over-the-counter hearing aids

Over-the-counter hearing aids have just been approved by the FDA according to the Reauthorization Act of 2017 along with an Executive Order by President Joe Biden in 2022. These devices are available to purchase from authorized retailers, and do not require a prescription from a healthcare professional. OTC hearing aids are designed to assist people aged 18 and older with mild-to-moderate hearing loss and offer an affordable and accessible hearing aid by eliminating the need for a visit to a healthcare provider. 


Prescription hearing aids

Prescription hearing aids need to be acquired through a licensed medical professional, such as an audiologist. These hearing aids are typically fitted and maintained by a hearing healthcare professional, after an examination to determine the extent of your hearing loss. Prescription hearing aids are incredibly expensive and can run upwards of $4000, which makes them quite inaccessible for the majority of people suffering from hearing loss. 

Personal Sound Amplification Products

Personal Sound Amplification Products, or PSAPs, are not classified as hearing aids and are not intended to treat those with any form of hearing loss. PSAPs can still be purchased without a medical prescription, or consultation from a medical professional, but they cannot be used to treat someone with hearing loss. These devices are intended to boost your ability to hear certain sounds in specific situations, such as bird hunting. PSAPs, therefore, are not regulated by the FDA as medical devices. 

When should I consult a healthcare professional?

There are some instances where it is recommended to consult with a healthcare professional before you purchase OTC hearing aids. If you currently experience, or have experienced, any of these examples please consult with a healthcare professional before purchasing any form of OTC hearing aid. 

  • Visible deformity of the ear, either present since birth or from trauma.
  • Fluid, pus, or blood coming out of the ear in the past 6 months.
  • Pain or discomfort in the ear.
  • History of excessive ear wax or suspicion that something is in the ear canal.
  • Episodes of vertigo (a sensation of spinning or swaying) or severe dizziness.
  • Sudden, quickly worsening, or fluctuating hearing loss in the past 6 months.
  • Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing between ears,

What are the challenges to OTC hearing aids?


Risk of improper treatment

OTC hearing aids, which treat mild-to-moderate hearing loss only, can be purchased in-store, which means you do not need to visit an audiologist, or other relevant medical professionals. However, it is important to make sure that your hearing loss is being managed correctly. Make sure that you purchase an OTC hearing aid developed by a reputable company, and that offers full remote care from product experts, such as Lexie Hearing. The remote support Lexie offers will help you ensure that your OTC hearing aid is functioning effectively and customized to your specific needs.


Lack of emotional support

When you start wearing a hearing aid, the brain takes time to adjust to how it processes audio. Typically, with prescription hearing aids, a person would be able to visit a hearing healthcare professional to check in and receive the emotional support and encouragement they might need. That might be more difficult to achieve with OTC hearing aids, unless you select a hearing aid provider that has a reliable customer care program. With Lexie Hearing, wearers are able to connect with Lexie ExpertsTM on demand 6 days a week, at no additional cost. 


Why choose Lexie Hearing?

Lexie Hearing offers a seamlessly integrated platform of OTC hearing aids for people living with mild-to-moderate hearing loss. Lexie Hearing also offers full remote care by Lexie ExpertsTM to ensure that you receive the best possible hearing experience and care. Lexie hearing aids are fully regulated by the FDA and have been developed by audiologists and experts in the hearing healthcare industry. 

Lexie hearing aids offer full customization through the smartphone app which offers incredible versatility and functionality. You can set various environment settings for different situations, adjust specific bass, treble, and overall volume levels, as well as the ability to adjust your hearing aid yourself to your personal sound preferences. Moreover, if you require any assistance with setting up your device, or are facing any other challenges, you have access to an unlimited support network of Lexie ExpertsTM to assist you. 

Lexie hearing aids can be purchased directly online or over-the-counter from your preferred retailer. To learn more about Lexie’s hearing solutions, contact us today or try our free online hearing test.

hearX Group and its subsidiaries are not healthcare providers. The information contained herein is solely for informational purposes. It is not intended to be a substitute for professional medical advice and should not be relied upon as healthcare or medical advice and is provided with the understanding that neither the author nor the publisher is engaged in or has the intention of rendering any legal, business, or medical advice.

The views and opinions expressed are those of the author and do not necessarily reflect the official policy or position of hearX Group or any of its subsidiaries. Although efforts are made to ensure that information is accurate, hearX, including its subsidiaries, cannot guarantee that all the information provided is correct, complete or up to date.

 You are advised to seek guidance from your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking medical advice or care because of the content published herein. If you choose to rely on any information provided by hearX Group or its subsidiaries, you do so entirely at your own risk.

Image of post writer Nausheen Dawood.

Written by Nausheen Dawood

M. Audiology; B. Communication Pathology in Audiology



You’re probably as excited as we are that Android™ call streaming is available to Lexie B2 and Lexie B2 Plus OTC hearing aids Powered by Bose wearers. This latest functionality opens a world of convenience and accessibility for individuals who rely on hearing aids to enhance their auditory experiences. The update process is designed to …

Read More

Lexie Hearing

May 7, 2024

Six Essential Hearing Aid Cleaning Tools

Keeping your hearing aids clean is important to make them last longer and work better. You need the right hearing aid cleaning tools and know-how to clean them properly. Luckily, there are lots of good options available to help you take care of your hearing aids—no matter what type of device you use. Here are …

Read More

Marcellé Swanepoel

April 26, 2024

Man holding his ear thinking of ear ringing myths

10 Tips To Remove Water From Your Ear

If you have water trapped in your ear canal, knowing how to clear it out can make a big difference. It’s not a pleasant feeling and can lead to muffled sounds, inflammation, and even the risk of an ear infection. Usually, the water will drain naturally, but there are times when it lingers, and you …

Read More

Natalie Gould

April 19, 2024