March 1, 2023

Acclarent Aera Eustachian Tube Balloon Dilation System

What is the Acclarent Aera?

The Acclarent Aera Eustachian Tube Balloon Dilation System is the first medical device available in the U.S. used to dilate (or expand) the Eustachian tube for patients with Eustachian tube dysfunction (ETD).

The Eustachian tube is a narrow passage connecting your nasopharynx to your middle ear cavity, located on either side. The Acclarent Aera device was purposefully designed with the flexibility and adaptability required to safely and effectively navigate this small, s-shaped channel. The device includes three major components:

1. The guiding catheter that houses the ballooning aspect of the device; this includes a curved ending near the tip to complement the anatomy of the nasal cavity.
2. The balloon that is inserted into and used to expand the Eustachian tube.
3. The actuator that is used to advance or retract the balloon.

The Acclarent Aera was designed with specific features to enhance its accuracy and safety, including:

1. A bulbous, atraumatic tip on the actuator to prevent it from being extended beyond the Eustachian tube into the narrow isthmus.
2. A yellow balloon marker on the actuator to indicate when the balloon is appropriately extended and ready to be inflated.

The Acclarent Aera design allows your trained physician to safely reach and dilate the Eustachian tube to address dysfunction while safely preserving the nasal and middle ear anatomy. This means it is primed to be safe for the surrounding soft tissues while providing maximal symptom relief.

How Does the Acclarent Aera Work?

The Acclarent Aera Eustachian tube balloon dilation procedure is a minimally invasive, low-risk intervention to address Eustachian tube dysfunction.

First, the Acclarent Aera’s guiding catheter is gently inserted into the nostril. The catheter is carefully maneuvered through the nasal cavity to the back of the nose until it reaches the Eustachian tube opening. The guiding catheter is then gently turned or positioned as needed to align with the opening.

Next, the actuator is used to extend the ballooning device into the Eustachian tube. Once extended into the tube, your doctor will inflate the balloon to expand and reshape the cartilage lining of the Eustachian tube. It is typically recommended that the balloon remain inflated in place for approximately 2 minutes to effectively stretch the cartilage lining.

After the inflation period, the balloon is deflated and retracted from the Eustachian tube and returned into the guiding catheter. Then, the guiding catheter is carefully removed from the nasal and nasopharynx passages. If you are experiencing symptoms in both ears, this procedure can be repeated on the opposite side within the same session.

Prior to scheduling your procedure, your doctor will likely conduct a visual examination or other imaging of the nasal cavity and middle ear. These exams help to confirm or rule out other causes of ETD and to determine if Eustachian tube balloon dilation is an option for you.

Once it is confirmed that Eustachian tube balloon dilation is the best approach, you will most likely be scheduled to have this procedure performed in an outpatient clinic or office setting. In these cases, a local anesthetic is applied directly to the nasal tissue for pain-numbing effects. Clients may experience minimal discomfort during the procedure.

Eustachian tube balloon dilation is also safe to be performed under general anesthesia with pain-numbing sedation in a surgical room if needed. Where your intervention occurs and the type of anesthesia used is determined by your physician’s preference and specific client needs.

Ask your doctor for more information about your procedure options.

If chronic sinus symptoms are still running your life, chat with us to find an ENT near you who can evaluate whether a procedure like Acclarent Aera is the right next step for clearer breathing.

What is Eustachian Tube Dysfunction?

The Eustachian tube is a narrow passage connecting your nasopharynx (back region of your nasal cavity) to your middle ear cavity, located in both ears. Usually closed when resting, the Eustachian tube opens while you chew, swallow, blow your nose, or yawn to help equalize pressure. It is also the area that you feel “pop” when trying to clear your ears while riding on an airplane, driving through the mountains, or diving underwater. The Eustachian tube also helps to protect the middle ear from diseases and to drain secretions away from the middle ear.

Eustachian tube dysfunction (ETD) occurs when the Eustachian tube is chronically experiencing difficulty closing or opening properly due to inflammation or blockages in the middle ear or throat, such that swelling or barriers may exist. This persisting inflammation or blockages can cause swelling or narrowing of the tube which ultimately limits the Eustachian tube’s functioning.

Other causes of ETD could include:

• Muscular dysfunction within the Eustachian tube lining
• Allergic inflammation of the nose (rhinitis) or nasal sinuses (rhinosinusitis) with pressure equalization and discomfort issues
• Other infectious or inflammatory conditions (e.g., viral upper respiratory infections)
• Tobacco use or tobacco smoke exposure
• Exposure to radiation or radiation therapy
• Exposure to nitrous oxide
• Deviated nasal septum
• Chronic reflux
• Cleft palate

ETD impacts nearly 5% of adults. Sometimes inflammation or drainage difficulties may be treated with medication or breathing maneuvers to improve your Eustachian tube functioning, such as equalization breathing techniques, decongestants, and/or antihistamines.

When improvements are not seen, problems are recurrent, or symptoms are persisting, you may be a candidate for the Acclarent Aera Eustachian tube balloon dilation procedure for fuller or longer-lasting symptom relief.

What are the Symptoms of Eustachian Tube Dysfunction?

Signs or symptoms of Eustachian tube dysfunction may include:

• Muffled or limited hearing
• Feeling one or both ears are clogged or plugged
• Feeling a clicking, popping, or tickling sensation in one or both ears
• Balance changes
• Ringing (or tinnitus) in one or both ears

Long-term, untreated ETD may be related to more serious conditions or complications including:

• Middle ear and ear drum damage over time
• Perforation of the eardrum
• Otitis media with effusion
• Collapsing (atelectasis) of the middle ear
• Adhesive otitis media, or adhesion of the middle ear structures.
• Cholesteatoma, or non-cancerous skin growth (keratosis), in the middle ear

Some people report that these symptoms worsen with changes in altitude (e.g., flying in a plane, driving through mountains, swimming underwater). If you believe that some of these signs and symptoms of ETD are impacting your quality of life, share your concerns with your physician.

What are the Benefits of Eustachian Tube Balloon Dilation?

According to a randomized controlled trial, the Acclarent Aera Eustachian Tube Balloon Dilation System has a 99.7% success rate for dilating the Eustachian tube as intended. The study also found the following patient benefits:

• 51.8% of people who underwent the Acclarent Aera procedure reported normalized ear pressure, compared to 13.9% of people who did not undergo the procedure.
• 56.1% of people who underwent the Acclarent Aera procedure reported improved quality of life, compared to 8.5% of people who did not undergo the procedure.
• Zero serious adverse events were reported during this specific study.

What are the Risks and Side Effects of Acclarent Balloon Inflation?

The Acclarent Aera Eustachian Tube Balloon Dilation System and the balloon dilation procedure are considered very low-risk and minimally invasive.

However, possible complications or side effects to consider include:

• Trauma to the tissues or mucosa of the nasopharynx and/or Eustachian tube
• Trauma to the carotid artery (very rare)
• Lack of symptom relief or improvement
• Nosebleed
• Infection

While associated risks are considered minimal and uncommon, it is important to discuss your specific case with your doctor to determine your personal risks and benefits.

What is the Recovery Like from the Acclarent Aera?

Typically, patients see their doctor for a follow-up appointment one week to one month after their Eustachian tube balloon dilation. At this appointment, you may be asked to try the Valsalva maneuver (e.g., hold your nose, close your mouth, and try to blow air out as if “popping” your ears) to evaluate Eustachian tube functioning and performance of the remodeled cartilage.

You may experience mild soreness and/or mild congestion for a few days after the procedure. Your doctor may prescribe a nasal spray to help with any discomfort while recovering. Most patients are cleared to return to work the same day, or within one to two days, after their Acclarent Eustachian tube balloon dilation intervention. You can resume most usual daily activities immediately.

While the Acclarent Aera Eustachian Tube Dilation System has proven beneficial for many people dealing with ETD, it is important to pick an intervention that best fits your wants and needs. Discuss your specific condition, treatment options, concerns for recovery, or anticipated benefits with your doctor to make a choice that is right for you.