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Clinical data

The Tula pivotal study is a prospective, multicenter study evaluating the safety and effectiveness of in-office ear tube placement with the Tula System in children aged 6 months to 12 years. The procedural and post-procedural results through 6-months follow up were published in 2020.1 A new publication extends the findings to show successful tube placement was accompanied by positive long‐term outcomes.2

Safe

Zero
serious device, drug, or procedure-related adverse events1

There were zero serious device, drug, or procedure-related adverse events in the study. Patients were treated in-office without use of sedation, anxiolytics or mechanical restraints. Behavior management techniques of distraction (toys, videos), engagement with patient, and framing (age-appropriate communication about the procedure) were among the methods used to minimize patient anxiety and distress.1

Practical

0
%
overall in-office success rate1

Procedural success was defined as tubes placed successfully in both ears for a bilateral case. 91% of patients in the Tula pivotal study were bilaterally indicated. Unsuccessful procedures were most commonly due to behavior (5%) or inadequate anesthesia (3.2%). In more than half (53.6%) of the cases that failed bilateral tube placements, doctors were able to successfully insert an ear tube in one ear.3

High parent satisfaction

0
%
of parents were very satisfied with the Tula procedure1

Parent satisfaction was recorded at the 3-week follow-up with 95% percent of parents noting “Strongly Agree” (82%) or “Agree” (13%) to the following statement: “Overall, I am very satisfied with the in-office ear tube procedure.” A total of 201 parents completed the survey.

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Physician experiences

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.

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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

Reimbursement

We provide a broad array of materials and tools along with a dedicated field team to support you throughout the reimbursement lifecycle. Payer engagement to expand coverage, policies, and patient access to the Tula procedure is a priority for our reimbursement team. Explore information on coding and billing for Tula, frequently asked questions, and published health policies in favor of Tula.

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Contact Us

To learn more about the Tula System, ask a question, or speak with your local Sales Representative, send us a message.

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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.  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.
  2.  Waldman EH, Ingram A, Vidrine DM, et al. Two-Year Outcomes After Pediatric In-Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System [published online ahead of print, 2023 Apr 1]. Otolaryngol Head Neck Surg. 2023;10.1002/ohn.336.
  3.  Data on file. Unpublished data from Tula pivotal study.

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