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The Tula System allows Ear, Nose and Throat (ENT) doctors to comfortably place ear tubes in awake children during an office visit. The FDA-Approved1 system consists of:
You and your child will meet the care team and get settled in the doctor’s office. The doctor will examine your child’s ears and size them for the earplugs.
The doctor will fill each ear with the numbing drug solution and place an earplug in each ear to keep the solution in place.
Your child will be quietly occupied for about 10 minutes, while the system uses a very low electrical current to deliver the numbing medicine to the eardrum. Your child may watch videos or play with toys during this time but should not touch the earplugs or cables. Throughout the procedure, you may remain with your child or your child may be seated in your lap.
Once your child’s ear drums are numb, a doctor’s assistant gently holds the child’s head still while the doctor quickly and safely inserts the tubes using a specialized device. In order to minimize the time your child must remain still, the specialized tube delivery system inserts the tube in less than half a second per ear.
Once the doctor has completed both ears, he/she will do one last check, and you and your child are free to go home. The procedure typically lasts about 35 minutes. Most children can return to normal activities right after the insertion of the ear tubes.
The Tula System is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION™, a combination of an amide local anesthetic and an alpha and beta-adrenergic agonist. Contraindications include certain abnormal ear anatomy, sensitivity/allergy to lidocaine or other local anesthetics, and reliance on electrically sensitive medical implants such as a pacemaker. Risks may include, but are not limited to, inadequate local anesthesia, dizziness, and common tympanostomy procedure risks. For full prescribing information, see the Tula IFU and TYMBION Drug Package Insert at www.tulatubes.com/IFU. Rx only.
The information presented about the Tula System is for educational, informational, and illustrative purposes only. It does not constitute and is not a substitute for medical advice and does not provide any indication, guide, or guarantee as to the response a child may have during a Tula System procedure.
1. Tula and drug solution TYMBION approved through PMA P190016
MKT007114 Rev A
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