What is Eustachian Tube?
The Eustachian tube is a narrow tube which links the back of the nose to the middle ear. It is normally closed but opens when we swallow, yawn or chew. It has three main functions: to protect the middle ear from sources of disease, to ventilate the middle ear, and to help drain secretions away from the middle ear.
Eustachian tube dysfunction (ETD) is the inability of the Eustachian tube to adequately perform these functions and failure of the valve of the Eustachian tube to open and/or close properly
ETD (Eustachian tube dysfunction) is estimated to effect up to 5%of the adult population.
Symptoms and Causes:
Normally, the Eustachian tubes are working properly so you don’t notice them at all.
Anything that prevents the tube from opening or closing properly can cause Eustachian tube dysfunction.
Eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open orclose properly. It can occur after the start of a cold and other nose, sinus, ear and throat infections.
When they are not working properly, the patient can possibly experience the following symptoms:muffled hearing, fullness of the ear, pain in the ear, inability to equilibrate middle ear (ME) pressure, tinnitus, and dizziness.
Complications from untreated ETD:
- Persistent Eustachian Tube Dysfunction can be associated with several serious conditions.
Long-term ETD has been associated with damage to the middle ear and the eardrum.
- Otitis media with effusion, atelectasis of the ME, adhesive otitis, perforation of eardrum and Cholestetoma.
Now, your physician has another option in treating Eustachian tube dysfunction (ETD).
The ACCLARENT AERA®Eustachian Tube Balloon Dilation System is the first device in the US indicated to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. The ACCLARENT AERA® device is intended to dilate the Eustachian tube for treatment of persistent ETD in patients ages 18 and older.
With the ACCLARENT AERA®system, a catheter is used to insert a small balloon through the patient’s nose and into the Eustachian tube. Once inflated, the balloon opens up a pathway for mucus and air to flow through the Eustachian tube, which may help restore proper function. After the Eustachian tube is dilated, the balloon is deflated and the catheter is removed.
- Results from a clinical study demonstrated a 99.7 percent technical success rate in Eustachian tubes dilated.
- This study also found a greater rate of tympanogram normalization than control subjects treated with medical management alone (51.8 vs. 13.9 percent), as well as a greater improvement in quality of life measures.
- 56.1% vs. 8.5% improvement in the Quality of Life measure from the Eustachian Tube Dysfunction Questionnaire (ETDQ-7).
- Additionally, there were zero reported serious device-or procedure-related adverse events.
The initial clinical trial of the ACCLARENTAERA®device only included patients under general anesthesia.6The most recent clearance recognizes that there is evidence of the ACCLARENT AERA®device being used under local anesthesia with appropriate preparation, which may include supplemental medication for patient management. Your physician will determine the appropriate practice setting and type of anesthesia to be used.
Acclarent AERA Eustachian Tube Dilation System
ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotidartery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices. The safety of the device as used under local anesthesia has not been evaluated.
Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. Third party trademarks used herein are trademarks of their respective owners. This site is intended for visitors from the United States and published by Acclarent, Inc., which is solely responsible for its contents.
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