In-office ear-tube placement system

The Tula System is FDA-approved for use in patients aged 6 months older.1 Explore the differences from a traditional tympanostomy:

Child-friendly, local anesthesia

The Tula Iontophoresis System applies a low-level electrical charge to the TYMBION™ ionic local anesthetic, accelerating drug uptake to numb the tympanic membrane.2

Rapid tube delivery

The Tula Tube Delivery Device allows a physician to create a myringotomy and insert an ear tube in one, automated step, minimizing the amount of time the child needs to remain still.2

Behavioral management program

The Tula System is supported with an educational and training program designed with input from experts in pediatric psychology, medical stress and pain management.

See how the Tula System works

Tula safety & efficacy

The Tula pivotal study included 337 subjects ages 6 months to 12 years. Discover the findings:

Safe

ZERO

serious device or drug related events2

Effective

95%

of ears were clear at three-week follow-up2

Practical

87%

in-office procedural success rate2

Parent
Approval

95%

of parents were very highly satisfied with procedure2

How Tula helps physicians

Parents of patients are looking for alternative solutions that don’t require a trip to the operating room or general anesthesia for tympanostomy tube placement. As a physician you want to provide a positive experience and effective care to your patients. The Tula System provides an opportunity to do both. An alternative to traditional tympanostomy, the Tula procedure can be done efficiently in-office using a revolutionary, local anesthesia with an automated, 1-click tube delivery device.

See what ENTs are saying:

“There’s hesitancy at any time you transition from an operative procedure to an office-based procedure, but what we’ve found is with proper instruction, proper patient identification, and proper technique, this procedure can be done safely and very efficiently in the office.”

–D. Macy Vidrine, MD, FAAOA

“I really like the Tula System because it gives parents the option of getting their child’s ear tubes placed without a general anesthetic. From a parent’s perspective, this is an enormous advantage – less time off work and performed in an office setting. This technology represents a broader movement in our field towards patient-centered therapies.”

–Lawrence R. Lustig, MD

“This personally hits home because my daughter had tubes when she was one year old, and we went to the operating room. I’m really excited that now we have the option to do that same procedure but in the office setting where a child wouldn’t have to be NPO, they could drink even during the procedure, and I think that’s a tremendous improvement in what we can do today.“

–Ritvik Mehta, MD

Find out if Tula is right for your practice.

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How Tula helps patients

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.3

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

Find out if Tula is right for your child.

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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.

  1. PMA P190016 Summary of Safety and Effectiveness, available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190016.
  2. 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. Satisfaction results from parents of children who participated in the Tula pivotal study, n=201.
  3. Data on file. Results from parents of children who participated in the Tula pivotal study, n=241.