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FAQs

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General

What is negative middle ear pressure?

Negative middle ear pressure occurs when the eustachian tube doesn’t open properly, creating a vacuum behind the eardrum. Normally, ears “pop” during swallowing or yawning to balance pressure. When this doesn’t happen, negative pressure can cause fluid buildup, discomfort, and impaired hearing.

What is otitis media with effusion (OME)?

Otitis media with effusion is a common condition where fluid fills the middle ear, often as a result of negative middle ear pressure. The fluid can cause a blocked sensation and disrupt hearing. Over time, it may become thick and sticky, which is why it’s sometimes called “glue ear”.

What are chronic ear infections?

Middle ear fluid can be a breeding ground for bacteria, leading to ear infections. When the fluid doesn’t resolve on its own, or a child has three or more ear infections in six months or four in a year, it’s called chronic ear infections.

How do I know if my child has fluid in their ears?

Fluid in the ears often causes hearing loss. Parents may notice their child struggling to hear, having delayed speech, or trouble paying attention at school.

What happens if fluid in the ear is left untreated?

Over time, fluid in the ear can become thicker, which may further reduce hearing. In young children, this can affect speech development, learning, sleep, behavior, and overall quality of life. Some studies have also found that children with long-term fluid buildup may have lower IQ scores later in childhood.

About Earflo

Who can use Earflo?

Earflo is FDA-cleared for ages two and up. While Earflo was designed for kids, it can also be used by adults, provided that one of the masks fits their nose.

Is Earflo safe for young children?

Yes, Earflo delivers gentle, controlled air pressure, similar to the natural sensation of your ears popping. Clinical studies have shown no known side effects. Unlike manual devices, Earflo precisely controls airflow to keep pressure within a clinically validated range, making it safe and effective for children as young as two.

Is Earflo considered a medical device?

Yes. Earflo is an FDA-cleared medical device designed to treat negative middle ear pressure and help prevent fluid buildup in the middle ear. It is safe for use in children ages 2 and up and adults, and has been studied in clinical trials for effectiveness and safety.

Has Earflo been clinically tested?

Yes. In a peer-reviewed clinicial trial, 86% of children using Earflo had an immediate improvement in middle ear pressure after a single treatment session. 86% showed a significant hearing improvement after four weeks, and 89% were not recommended for ear tube surgery after four weeks.

How is Earflo different from other ear pressure devices?

Other ear pressure devices require complex coordination that young children simply can’t manage. Earflo does the work for the child, delivering a gentle puff of air as they drink. Built-in sensors detect each successful treatment, confirmed through light indicators and the companion app. The app also turns treatment into a game, keeping kids motivated and on track.

How was Earflo developed?

The founders of Earflo are biomedical engineers and ENT surgeons who are also parents. They understand how challenging it can be to get young children to follow a treatment plan. So, Earflo includes a companion app that turns treatment into a game, keeping kids motivated.

What recognition has Earflo received?

Earflo has been recognized internationally for its innovative design and engineering. Awards include the CES Best of Innovation in Digital Health, TIME’s Best Inventions of 2025, a Gold Anthem Award in Health Innovation, and the World Congress of Audiology Innovation Prize.

Using Earflo

How do I know if Earflo is right for my child?

Earflo is FDA-cleared for people ages two and up who have negative middle ear pressure. If your child has symptoms such as blocked or “full” ears, muffled hearing, ear pressure, popping sensations, or fluid in the ear, Earflo may help restore normal ear pressure. If you’re unsure whether it’s right for your child, it’s always a good idea to check with your doctor first.

Can Earflo help my child avoid ear tube surgery?

Earflo is designed as a non-surgical treatment option for children experiencing negative middle ear pressure. In clinical trials, 89% of children who used Earflo did not require ear tube surgery after the four-week treatment period.

What does it feel like to use Earflo?

Using Earflo isn’t all that different from drinking through a sippy cup. The child sips through the straw while pressing their nose into the mask to create a seal. Earflo detects the swallow and pushes a gentle puff of air into the nose. Some children may notice a pop, click, or crackle sound when the eustachian tube equalizes, along with a potential immediate hearing improvement.

How quickly does Earflo work?

Most patients show an immediate clinical improvement the first time they use Earflo. We recommend using Earflo twice daily for 2–4 weeks to significantly improve hearing.

What does the Earflo app do?

The Earflo companion app helps kids learn how to use Earflo, motivates them to keep using it over time, and helps parents and clinicians track treatment sessions and progress.

Orders & Shipping

Does Earflo require a prescription?

Earflo is available over-the-counter and does not require a prescription.

Is Earflo HSA and FSA eligible?

Earflo is HSA and FSA eligible. We recommend confirming with your provider, as coverage details can vary by plan.

Is Earflo covered by insurance?

Some insurance plans may cover Earflo, but we recommend confirming with your provider, as coverage details can vary by plan.

Is Earflo available outside of the United States?

Earflo is not currently available internationally, as it is a medical device with US FDA regulatory clearance only.

How much is shipping?

USPS ground shipping is free on all orders for a limited time. Priority shipping is available for an additional fee.

How long does shipping take?

Orders ship via USPS or OnTrac from our warehouse in California. Shipping typically takes anywhere from two days for west coast locations to five or more days to the east coast, Alaska, and Hawaii.

What is the warranty and return policy?

Earflo comes with a one-year limited warranty covering manufacturing defects under normal use. This warranty is limited to replacement of the product and does not provide refunds. Damage caused by accidents or misuse is excluded. Because Earflo is a medical device that comes into contact with your child, we are unable to accept returns outside of warranty claims. If something isn’t right, please reach out and we’ll make it right.

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