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FDA grants over-the-counter (OTC) options for hearing aids

On October 17, more than 35 million Americans with mild to moderate hearing loss can get a hearing aid over the counter (OTC) for the first time at stores across the country. as the U.S. Food and Drug Administration's (FDA) rule, announced in August, goes into effect.

Until now, the most common barriers to hearing care were cost and access. According to the Better Hearing Institute, 68% of people with hearing loss cite finances as the main reason for not using hearing aids.

Today, addressing hearing loss doesn’t have to be expensive. People can get audiologist-quality hearing aids online without a prescription for as little as $799 compared to upwards of $4,000 for an audiologist-prescribed hearing aid.

"I’m pleased to know that the millions of Americans who need them will now have access to affordable, quality OTC hearing aids," said Seline van der Wat, Chief Operating Officer at hearX Group.

van der Wat is part of an innovative team at hearX Group, creating game-changing access to quality OTC hearing aids in the U.S. market, making hearing affordable and accessible to everyone. Lexie Hearing is hearX Group's response to providing direct-to-consumer hearing aids in the United States. Lexie Hearing will begin selling its award-winning products at more than 11,000 pharmacies and retail stores in the U.S. on October 17, 2022. MDW is proud to feature Lexie Hearing as the new FDA ruling is put into effect and share their tips for identifying the signs of hearing loss.

Hearing Loss Tips

Turning the volume louder or asking people to repeat themselves are all signs of hearing loss, but there are other, more subtle signs of hearing loss that is important to know.:

1. The top two risk factors for hearing loss are age and exposure.

  • Most hearing loss is age-related, but it can start earlier than you might think. By the age of 50, you should be regularly testing your hearing.

  • Exposure to loud noise is another major risk factor for hearing loss. While job-related noise exposure is responsible for most exposure-related hearing loss, recreational activities, like listening to loud music, can also play a role.

2. Hearing loss is exhausting.

People with untreated hearing loss typically experience exhaustion at the end of the day. Many dismiss it as a symptom of old age, but the fact is it takes tremendous energy to distinguish between different sounds and focus on individual conversations. If you’re exhausted from a day at the office, check your hearing. You can do it for free at

3. Correcting hearing loss is important for overall health.

Untreated hearing loss has been associated with an increased risk of mental, physical, and cognitive challenges, including falls, depression, anxiety, and dementia.

Tips for choosing an OTC device

  • Get a digital hearing aid, which will have better features and functionality than analog hearing aids.

  • Look for “self-fit technology.” A person’s hearing is as unique as their fingerprint, and self-fit technology provides a more customized, and therefore more clinically accurate solution.

  • Look for a hearing aid that comes with free, remote support, so that you’re never left in the lurch. One of the benefits of over-the-counter hearing aids is that you don’t have to rely on an audiologist for tuning and service. You want a device that gives you substitute service in case you run into any challenges.

  • Review the App store ratings before purchasing, if your hearing aid runs from a phone app. Make sure there’s a track record of happy customers.

While hearing loss can occur at any age, hearing difficulties increased with age among men and women aged 45 and over. [1]

If you're looking for OTC options, Lexie offers three unique models and just launched the Lexie B2 Hearing Aid, powered by Bose.

Lexie B2

The Lexie B2, Powered by Bose, are receiver-in-canal hearing aids that offer a more natural and clear sound experience.

They feature the world’s first self-tuning system that pairs with the Lexie app, clinically proven to provide audiologist quality customization. The Lexie B2 rechargeable battery provides all-day battery life of up to 18 hours, all from a 3-hour charge time. Wearers can also adjust treble and bass frequencies.

Lexie B1

The Lexie B1, Powered by Bose is a first-of-their-kind receiver-in-canal hearing aid, Bluetooth enabled, and can be personalized to a user’s needs. Lexie B1 hearing aids pair with the Lexie app, the first self-tuning mobile app that’s clinically proven to provide audiologist-quality customization for those with mild to moderate hearing loss.

Lexie Lumen

The Lexie Lumen is a Bluetooth-enabled hearing aid that can be customized according to a person’s unique hearing profile. Users can pair the Lumen to the Lexie app, take the in-app hearing check, and the hearing aids will automatically adjust according to their hearing profile. Suitable for individuals 18 or older with perceived mild to moderate hearing loss.

To learn more about Lexie Hearing and where you can find a hearing aid in your area, visit



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