Ear tubes done differently

With Tula, you can have your child’s ear tubes placed right in the doctor’s office. No operating room, no general anesthesia, and you can stay with your child the entire time.

What is Tula

The Tula System allows Ear, Nose and Throat (ENT) doctors to comfortably place ear tubes in awake children during an office visit.¹ The procedure typically takes about 35 minutes,²and most children can return to normal activities right after the ear tubes are inserted.³

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Procedure information

If your ENT doctor has recommended ear tubes, you have a choice for your child’s procedure. Traditionally, ear tube surgery is performed in an operating room at a hospital or ambulatory surgery center while your child is under general anesthesia. With Tula, ear tubes are done differently – right in the doctor’s office.

Ear tubes are safe and effective whether they are placed in the hospital operating room or in the doctor’s office with Tula. Ear tubes may reduce the risk of future ear infection, restore hearing loss caused by fluid in the ear, improve speech and balance problems, and improve behavior problems related to ear infections.^3,4

Your doctor will help you decide which option is right for your child.

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Patient experiences

Traditional ear tube procedures require a trip the operating room (OR) and general anesthesia. The Tula System is an alternative option for ear tube placement that can be done directly in your ENT’s office. In a survey, parents considering the Tula procedure for their child indicated that the most important reasons to select Tula over the OR are preferring local to general anesthesia and wanting to stay with their child.⁵

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See what parents are saying:

“For me, it wasn’t a choice between settings. It was are we going to wait and see if things improve or are we going to do Tula? I had already decided against tubes if we had to do the procedure in the OR because I wanted to avoid general anesthesia. Tula was the difference, and I would make that choice again.”

Kate, mom of Tula patient

“Both being in the medical field, we’re familiar with what tube placement entails. She didn’t have to be separated from us – that was huge to not have to hand her over to strangers. We sat right there with her, held her hand, talked to her. Every day of the week I would choose the in-office procedure.”

Sarah, mom of Tula patient

“After she got her ear tubes in, we were able to go straight home, she was her normal self, she was playing, she was able to come home and eat dinner. You’ve got to get the tubes one way or another. You might as well do it this way. It’s a heck of a lot better, a heck of a lot easier in the long-run.”

Kristen mom of Tula patient

“When the ENT described putting tubes in his ears in the office, I was glad because I didn’t want him to have go under anesthesia, go to the hospital, and be scared. And, I was actually surprised that they could even do that. For Braedon not going to the hospital was a big relief.”

Brandy, mom of Tula patient

“We made it a mom and Henry adventure. We went in the morning to have his tubes placed and went immediately after and got lunch and ice cream, and then we went to school. So it was easy.”

Bonnie, mom of Tula patient

Frequently asked questions

Is the Tula System safe?

Yes, The Tula System has been demonstrated as safe and effective in clinical studies.^3,6

Is the Tula System FDA approved?

Yes, the FDA approved the Tula System in November 2019 for use in both adults and children as young as six months of age.

In announcing the approval, Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, stated, “Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anesthesia. As millions of children suffer from ear infections every year, it is important to have safe and effective treatments available to this susceptible patient population. This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort.”

More discussion on comfort level experienced by patients can be found here.

More information regarding the FDA’s approval can be found on the FDA website.

Are Tula ear tubes the same as the ones inserted in the Operating Room?

There are many different types of ear tubes. Tula ear tubes are designed to be similar in size, function, and quality as ear tubes commonly used in the Operating Room.

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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.
Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical Practice Guideline: Tympanostomy Tubes in Children (Update). Otolaryngology–Head and Neck Surgery. 2022;166(1_suppl):S1-S55.
Data on file. Results from parents of children who participated in the Tula pivotal study, n=241.
PMA P190016 Summary of Safety and Effectiveness