Visualizing Acute Otitis Media with Non-Invasive OtoSight Technology

In this White Paper titled Visualizing Acute Otitis Media with Non-Invasive OtoSight Technology: Advanced OCT-Based Imaging of the Tympanic Membrane and Middle Ear Effusion Changes across Course of Treatment, Michael A. Novak MD (Carle Foundation Hospital, Department of Otolaryngology, University of Illinois at Urbana-Champaign, Carle-Illinois College of Medicine, Urbana, Illinois, United States) presents a longitudinal analysis demonstrating how the middle ear scan helps to determine the presence or absence of fluid in the middle ear, characterize the type of fluid, visualize the fluid’s density, and can do all of this even in the presence of significant wax.

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What a Middle Ear Infection Looks Like

Despite its small size, the ear is a very complicated organ. The three main parts of the ear are known as the inner, middle, and outer ear. PhotoniCare focus their research and work on the middle ear. The middle ear is the area located directly behind the eardrum.

Most middle ear infections are caused by either bacteria or viruses. A common cold, the flu, or allergy symptoms that cause congestion and swelling of the nasal passages, throat, and eustachian tubes can sometimes lead to an infection. Anything that makes the nose stuffy has a tendency to cause swelling and blockage of the eustachian tubes. Swelling from colds or allergies can keep the eustachian tubes from opening and this leads to pressure changes and the accumulation of fluid in the middle ear. This pressure and fluid will cause pain and sometimes persistent fluid can lead to an infection.

When a healthcare provider checks you or your child for an ear infection, they will typically use an instrument called an otoscope. An otoscope is basically a pen light attached to a magnifying glass, and this simple device has been used in medicine for the past 150 years. The otoscope comes with several pointed tips called specula. A speculum is chosen based on the size of the patient’s ear opening. The healthcare provider will gently insert the speculum into the ear canal to look at the surface of the eardrum. The otoscope will allow the provider to look at the surface of the eardrum.

Note: These are ideal, textbook images of the surface of the eardrum that you or your family healthcare provider rarely see because there may be wax blocking his/her view, or the patient may be uncooperative, which prevents proper positioning of the otoscope. These real-life impediments are what makes diagnosing AOM so difficult.

When to Visit Your Healthcare Provider
Ear pain and concerns about hearing are one of the most common reasons parents take their children to the doctor. If you suspect that your child has an ear infection, then the #EnginEarGuys recommend you contact your healthcare provider. A provider will examine your child’s ear for an infection or if there is another issue causing your child’s symptoms and pain. If the provider does suspect an ear infection, antibiotics may or may not  be recommended. 

Generally speaking, an ear infection has the potential to resolve itself without antibiotic treatment. In the case of a severe middle ear infection with infected fluid in the middle ear, the American Academy of Pediatrics recommends the physician prescribe antibiotics. However, the guidelines recommend the “watchful waiting” approach for non-severe middle ear infections in children over the age of two. The overall goal is to reduce over-prescription of antibiotics.

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Antibiotic Stewardship Programs

What the heck is an Antibiotic/Antimicrobial Stewardship Program (ASP) and what does it have to do with my child’s earache?

Two great questions!  Let us tackle the ASP question first. In general, this term refers to programs put in place by your healthcare provider, in conjunction with guidelines developed by local hospitals or the Centers for Disease Control and Prevention (CDC),  to ensure that antibiotics are prescribed appropriately. Antibiotics play an important role in fighting infection, but when prescribed inappropriately, such as for viral infections or a non-bacteria related middle ear problem, the correct course of treatment is delayed, and the potential for unrelated bacteria to develop resistance to the prescribed antibiotic(s) can become a problem.  

OK, nice to know, but how does this relate to the very real problem of your child’s earache?  The key here is for the healthcare provider to determine if the problem is bacterial in nature or not. Ear pain (otalgia) or redness of the eardrum are some of the signs of Acute Otitis Media (AOM), but as we’ve learned from previous blog posts, other conditions, such as the common cold or pharyngitis can also cause these symptoms. The American Academy of Pediatrics AOM guidelines state that fluid must be present in the middle ear to definitively diagnose AOM. This buildup of fluid and pressure in the middle ear is the direct result of a bacterial infection that would, in most cases, be treated with antibiotics. However, determining if there is fluid in the middle ear is difficult today because the tools currently available are unable to actually image the contents of the middle ear. Given that, the misdiagnosis rate for middle ear related problems is quite high and may result in overuse of antibiotics.

Devices like the OtoSight Middle Ear Scope will allow your healthcare provider to determine the absence or presence of fluid in the middle ear even when there’s occluding ear wax, allowing them to achieve more than a 90% accuracy rate assessing MEE*.

_{*Otolaryngol Head Neck Surg. 2020 Mar;162(3):367-374}

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What a Middle Ear Infection Looks Like Using the OtoSight Middle Ear Scope

Despite its small size, the ear is a very complicated organ. The three main parts of the ear are known as the inner, middle, and outer ear. At PhotoniCare, we focus our efforts on the middle ear. The middle ear is the area located directly behind the eardrum. 

The Middle Ear
Most middle ear infections are caused by either bacteria or viruses. A common cold, the flu, or allergy symptoms that cause congestion and swelling of the nasal passages, throat, and eustachian tubes can sometimes lead to an infection. Anything that makes the nose stuffy has a tendency to cause swelling and blockage of the eustachian tubes. Swelling from colds or allergies can keep the eustachian tubes from opening and this leads to pressure changes and the accumulation of fluid in the middle ear. This pressure and fluid will cause pain and sometimes persistent fluid can lead to an infection.

Viewing the Surface of the Eardrum
Traditionally, when a healthcare provider checks you or your child for an ear infection, they use an instrument called an otoscope. An otoscope is basically a pen light attached to a magnifying glass, and this simple device has been used in medicine for the past 150 years. The otoscope comes with several pointed tips called specula. A speculum is chosen based on the size of the patient’s ear opening. To use the otoscope, a healthcare provider gently inserts the appropriately sized speculum into the ear canal to look at the surface of the eardrum. 

Traditional otoscopy offers a high-level of variability and subjective observation based on the clinician experience and patient cooperation. Additionally, there may be wax blocking his/her view, or the patient may be uncooperative (think tired and sick child), which prevents proper positioning of the otoscope. These real-life impediments are what makes diagnosing AOM so difficult. Improvements in technology, like the OtoSight Middle Ear Scope, aim to bring clarity to this very subjective process of assessing middle ear health.

A New View of the Middle Ear
In the search for a solution, there has never been a method to non-invasively ascertain the contents of the middle ear, a key determinant when considering an infection diagnosis such as Acute Otitis Media (AOM) – until now!

The OtoSight Middle Ear Scope uses a novel application of Optical Coherence Tomography (OCT) to directly visualize fluid in the middle ear, a key determinant when following AAP Guidelines for diagnosing middle ear infections such as AOM. The technology in the OtoSight Middle Ear Scope is 90.6% accurate when assessing MEE*. This is a significant increase over the 50% accuracy with standard otoscopy published in 2001**.

How to Interpret an middle ear scan

Unlike other technologies, OtoSight can accurately determine middle ear effusion, even in the presence of cerumen. In this video, we’ll share with you how to understand and interpret at OtoSight Exam.

Click here to learn how to interpret an middle ear scan

When to Visit Your Healthcare Provider
Ear pain and concerns about hearing are one of the most common reasons parents take their children to the doctor. If you suspect that your child has an ear infection, then PhotoniCare recommends that you contact your healthcare provider. A healthcare provider will examine your child’s ear for an infection or if there is another issue causing your child’s symptoms and pain. If the healthcare provider does suspect an ear infection, antibiotics may or may not  be recommended. Generally speaking, an ear infection has the potential to resolve itself without antibiotic treatment. In the case of a severe middle ear infection with infected fluid in the middle ear, the American Academy of Pediatrics recommends the healthcare provider prescribe antibiotics. However, the guidelines recommend the “watchful waiting” approach for non-severe middle ear infections in children over the age of two. The overall goal is to reduce over-prescription of antibiotics. 

_{*Otolaryngol Head Neck Surg. 2020 Mar;162(3):367-374
**Arch Pediatr Adolesc Med. 2001;155(10):1137-1142.}

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Meet OtoSight Middle Ear Scope

Eight out of 10 children will have a middle ear infection, and as a parent or caregiver, you know how ear infections can not only be tough for you to manage, but painful and uncomfortable for your child. 

PhotoniCare’s missions is to make a real impact on the health of children. We started with middle ear infections because of our personal experience with this disease, as both parents and patients.

Why OtoSight Middle Ear Scope?

Ear infections are the leading cause of surgery and hearing loss in children, and responsible for $10 billion in related healthcare costs and 30 million office visits each year in the United States alone. What is interesting to note is that the tool most used in the diagnosis of middle ear infections hasn’t changed in over 100 years!  Yes, you read that correctly — the technology in otoscope that is used to visualize the surface of the eardrum, has fundamentally remained unchanged for 100+ years. Although now a bit sleeker and more lightweight, the design and the technology has not changed appreciably, while the need to diagnose acute otitis media (AOM) more accurately has increased dramatically in the age of antibiotic resistance and super-bugs. With a published misdiagnosis rate approaching 50% among primary care healthcare providers*, there is a real need for the OtoSight Middle Ear Scope.

AN ADVANCED OCT IMAGER IN MINIATURE

Our easy-to-use OtoSight Middle Ear Scope is designed to look, and handle, just like the familiar otoscope. However, unlike the otoscope, the OtoSight Middle Ear Scope uses an advanced light-based technology called optical coherence tomography (OCT) to see through the eardrum. Now, healthcare providers can view a high-resolution depth image on-screen to learn what’s going on in the middle ear. OtoSight is capable of helping clinicians make better decisions leading to improved outcomes and quicker time to restored ear health.

OBJECTIVE TREATMENT DECISIONS

Ear infections are the leading cause of antibiotic over-prescription and antibiotic resistance development. middle ear scan provide objective data for healthcare providers to increase confidence in their treatment plan. The

The OtoSight Middle Ear Scope has the potential to fundamentally transform the management of middle ear infections. Our long-awaited, non-invasive solution adds objective data to the diagnostic equation, giving hope to improved quality of care for children worldwide. 

_{*Arch Pediatr Adolesc Med. 2001;155(10):1137-1142.}

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Talking About Ear Tubes with Dr. Michael Novak

Eight out of 10 children will have a middle ear infection, but what if your child seems to have them more than what you think is normal? What if your child seems to have difficulty hearing, and complains about “water in the ear” when there doesn’t seem to be a reason for it? When this happens, it may be time to seek help by calling your primary care doctor, who may refer you to an ENT specialist, for the best next steps for your child’s ear health. 

For some children, the next best step in managing your child’s ear health is the placement of tubes within the eardrum, also known as tympanostomy tubes. About 700,000 children each year have ear tubes surgically placed t, according to the American Academy of Otolaryngology-Head and Neck Surgery. Ear tubes typically cost around $2-5,000, most of which is usually covered by insurance. The surgery does carry some risk, partly because the child will be put under general anesthesia. 

We sat down with Dr. Michael Novak, an Ear, Nose and Throat doctor from Carle Foundation Hospital in Urbana, Illinois, to chat more about ear tubes and specifically why the fall and winter months are a common time for placement of ear tubes.

What are the common reasons for tube placement in children?
Tubes are generally placed in children to treat frequent infections (4 or more over a 6 month period) or persistent fluid in the middle ear (fluid that stays in the ear for at least 3 months).

If a child is a candidate for this type of surgery, why are the fall and winter months the most common time for tube placement?
The most common times for tube placement are late fall and early winter since the infections and fluid typically are caused by colds and flu. It may take 3 months or more to determine that a child is prone to ear infections and would benefit from tubes. The pattern of frequent infections tends to start in the late summer or early fall when kids get back into school and start sharing viruses, and we are indoors where colds can be communicated more easily. 

Is there immediate relief for the child after the tubes are placed?
Yes, the relief of the infection and removal of fluid gives immediate relief from pain and hearing loss. The improvement continues over 2-3 days as the ear returns to normal.

What are the general instructions and follow-up care for ear tubes?
I tell my patients to where ear plugs when they are swimming in lakes and rivers where   the water is not as clean as the swimming pool or shower. Otherwise, there are no special precautions necessary for the great majority of children. If drainage from the ear develops, it is treated with topical antibiotic and corticosteroid drops, and usually clears up quickly.

Thank you Dr. Mike for the fantastic insight regarding ear tubes – paying attention to the frequency and time of year of ear problems are key to a successful outcome!  

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The Real Cost of Ear Infections

Middle ear infections, or otitis media, are very common. So common, in fact, that 90% of children will suffer from an ear infection in their childhood. You may notice your child being more fussy than usual, tugging on their ear and grimacing, or complaining about a sharp pain in the ear. These are all common ear infection systems which often lead a parent to take their child to a healthcare provider. 

Because ear infections are the most common ailment among kids it can cost a significant amount to the consumer and the health care system. With healthcare expenses on scrutiny now more than ever, we break down the real cost for ear infections, and how our technology will empower healthcare providers to make better decisions, and reduce costs exponentially. 

By the Numbers
If a parent brings their child into the office to see a healthcare provider, hits to the pocketbook begin to escalate:

• A typical visit to a healthcare provider’s office costs between $25 and $250.
• Copays for office visits range from $5 and $75, depending on the insurance company.

In addition to an office visit, there are many parents who take their child for ear pain treatment to urgent care or the emergency room. Debt.org reported on an Annals of Internal Medicine study that found the average cost of an urgent care visit for three common illnesses — middle ear infection, pharyngitis and urinary tract infection — was $155. Other estimates place the average urgent care visit at anywhere from $71 to $125. There are also instances where a parent may take their child to the emergency room for ear pain. Debt.org reports that an average emergency room visit for ear pain can cost an average of $400. 

Antibiotics
Besides being so prevalent among children, ear infections are also the leading cause of antibiotic over-prescription and antibiotic resistance development. Antibiotics play an important role in fighting infection, but when prescribed inappropriately, such as for viral infections or a non-bacteria related middle ear problem, the correct course of treatment is delayed, and the potential for unrelated bacteria to develop resistance to the prescribed antibiotic(s) can become a problem. 

Antibiotics also come with a price tag for parents:

• Antibiotics typically prescribed for a bacterial ear infection, such as Amoxicillin, cost between $20 and $110 for a week’s treatment. 
• Copays for the prescription ranges from $5 to $50.

Devices like OtoSight Middle Ear Scope will allow your healthcare provider to image the contents of the middle ear– providing key access to the information needed for a correct diagnosis and the first step in being a good Antibiotic Steward and reducing costs, both to you and the healthcare environment! 

Surgery
For some children, the next best step in managing your child’s ear health is the placement of tubes within the eardrum. About 700,000 children each year have ear tubes surgically placed, according to the American Academy of Otolaryngology-Head and Neck Surgery. Ear tubes typically cost around $2,000-5,000 for people with insurance.  

Diagnosing Ear Infections
The American Academy of Pediatrics AOM guidelines state that fluid must be present in the middle ear to definitively diagnose Acute Otitis Media (AOM). This buildup of fluid and pressure in the middle ear is the direct result of a microbial infection that would, in many cases, be treated with antibiotics. However, determining if there is fluid in the middle ear is difficult today because the tools currently available measure or view the eardrum only, rather than measuring the potential fluid directly. In the current paradigm of care, the eardrum is observed as a proxy for middle ear health.

Current tools used to diagnose fluid in the middle ear can be difficult to use reliably in squirming or crying children, and rely heavily on user expertise to interpret a simple image or measurement of the eardrum. In the primary care setting, otoscopic accuracy has been reported to be as low as 50%. By the numbers, half of all children are not given an accurate diagnosis. The result? Increased costs for payers and over prescription of antibiotics for the patient. 

• Ear infections, in general, are responsible for $10 billion in related healthcare costs
• AOM  infections are the cause of 30 million office visits each year in the United States alone. 

PhotoniCare’s mission is to make a real impact on the health of children – that’s why we started with middle ear infections. Our goal with our first product, the OtoSight Middle Ear Scope, is to revolutionize the diagnosis, treatment, and monitoring of middle ear infections. 

The Future of Diagnosing Ear Infections
The technology harnessed by the OtoSight Middle Ear Scope is a quantum leap over the current standard, in that OtoSight Middle Ear Scope can actually see evidence of disease in the middle ear. All other technologies on the market are using the eardrum as a proxy to diagnose middle ear disease – this methodology is inherently problematic as it does not reflect accurately enough the actual condition of the middle ear. In other words, you get what you see – OtoSight Middle Ear Scope technology allows healthcare providers to actually see the contents of the middle ear, such as fluid, and this is the first step in diagnosing middle ear disease accurately. No proxies, no guessing. 

The OtoSight Middle Ear Scope has the potential to fundamentally transform the diagnosis and treatment of middle ear infection. It could improve the quality of care for one billion children worldwide, empower healthcare providers to make better decisions, and reduce costs exponentially. We are so excited to get this technology out to patients as soon as possible. Thanks, as always, for being part of our journey.

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