What is the Tula System?

The Tula System allows Ear, Nose and Throat (ENT) doctors to comfortably place ear tubes in awake children during an office visit.¹ The Tula procedure has two main steps:

First, your child’s eardrums are numbed using specially designed earplugs and a numbing drug solution.
Then, the Tula device is used to insert the ear tubes quickly and safely.

See how the Tula System works

Tula ear tubes are designed to be similar in size, function, and quality as ear tubes commonly used in the operating room. The procedure typically takes about 35 minutes,² and most children can return to normal activities right after the ear tubes are inserted.³

Tips for parents

As a parent, you play an important role in your child’s procedure from preparing your child ahead of time to helping to celebrate with them afterwards! Check out the tips for parents below.

Tips

Prepare your child: Read the Tula Children’s Storybook together a few days prior to the procedure. Pick out some of your child’s favorite things to bring to the procedure such as a comfort item (stuffed animal, blanket), distraction items (handheld game, video, toy), and snacks or drinks.

On procedure day: Make sure your child is rested and has eaten a snack or meal. Being calm and confident will help put your child at ease. Make sure your child uses the restroom prior to the procedure.

During the procedure: Be specific with praise. For example, “You’re doing a great job sitting up so tall in the chair!” Use your favorite games, songs, and toys to occupy your child. Comfort your child by holding hands, providing a reassuring touch, or using the “bear hug” technique.

Help your child stay calm: Let your child know that it won’t hurt but will sound loud. Help your child to remain relaxed by breathing slowly 3x together. Let your child know this is the last step, and talk about what you’ll do after the procedure.

Celebrate: Let your child know that you are proud of their success in getting ear tubes. Help your child choose a special treat to help them remember the experience positively in the future. You deserve a treat too!

Ask your ENT for a copy of our parent guide for more detailed information.

Safety and efficacy

The Tula System has been demonstrated to be safe and effective in clinical studies. Patients were treated in the doctor’s office without sedation or general anesthesia. Behavior management techniques of distraction with toys and videos, engagement with patient, and age-appropriate communication about the procedure were among the methods used to minimize patient anxiety and distress.³

Safe

Zero

Demonstrated Safe

There were zero serious device, drug, or procedure-related adverse events in the study.³

Effective

High success rate

ENT doctors were able to successfully insert tubes in 87% of the children.³ If the Tula procedure is not successful or cannot be completed, your ENT doctor may reschedule the procedure in the OR.

Parent Approved

High parent satisfaction

95% of parents in the most recent study were very satisfied with the Tula procedure.³

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.

IFU007011, available at www.tulatubes.com/IFU
Data on file. Tula Pivotal Study.
Lustig LR, Ingram A, Vidrine DM, et al. In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery. Laryngoscope. 2020;130 Suppl 4(Suppl 4):S1-S9. Results from parents of children who participated in the Tula pivotal study, n=201.