The TULA® System is an in-office alternative to traditional tympanostomy. TULA uses a revolutionary local anesthesia system, and an automated 1-click tube delivery device.
Midwest ENT & Allergy is proud to announce that we now offer the ground-breaking Tula System, which enables ear tube (or tympanostomy) procedures in the clinic without the operating room or general anesthesia. The TULA System is approved for patients aged 6-months and older.
Each year, approximately 700,000 ear tube surgeries are performed in the US on children in an operating room, making it the most common childhood surgery performed with general anesthesia.
Recurrent ear infections and / or persistent fluid in the middle ear may lead to other issues involving speech, hearing, school performance, lack of sleep and repeated rounds of antibiotics.
The innovative Tula System gives parents an option for in-office placement of ear tubes using a child-friendly system to numb the eardrum while the child can play or watch videos. Throughout the procedure, parents may stay with their child. The Tula system has been shown to be safe and effective in clinical studies, and 95% of parents in the most recent study were satisfied with the procedure.
The technology allows physicians to create a myringotomy and insert a tube in less than half a second, minimizing the amount of time a child needs to remain still. The overall procedure is completed in a single office visit lasting around 35 minutes, and parents can stay with their child throughout. Since no general anesthestic or sedation medications are required, the child does not need to fast before the procedure, and in fact, is able to have a snack while the Tula procedure is performed.
Most children can return to normal activity immediately after the procedure. Clinical results: In the recent clinical study of 337 subjects aged 6 months to 12 years, Tula was shown to be safe and effective. There were zero device, drug, or procedure-related serious adverse events.
- Overall procedure success of 87% (86% in children under 5, and 89% in children 5-12 yrs)
- 95% of parents were very satisfied with their Tula procedure (results from parents of children who participated in the Tula pivotal clinical study, n=201-203)
- 94% tube patency at 3-week follow-up.
- Average procedure time was around 35 minutes.
Pros and Cons of the TULA Tympanostomy System
Operating Room – Pros
- Your child is asleep and immobile during the procedure
- This surgery has historically been the standard of care
Operating Room – Cons
- Possible side effects and complications of general anesthesia
- Fasting is required prior to surgery
- You will be separated from your child during the procedure
Doctor’s Office with Tula – Pros
- Avoid a trip to the operating room. No general anesthesia.
- You can stay with your child.
- Your child can likely return to normal activities immediately following procedure without grogginess.
- No fasting. Your child can eat or drink during the procedure.
Doctor’s Office with Tula – Cons
- Your child must be willing to wear earplugs for about 10 minutes and sit still for ear tube insertion.
- Your child may be rescheduled for a procedure in the Operating Room if the in-office procedure is not successful. Rescheduling may be necessary if the numbing medication is ineffective or if your child is unable to sit still.
Find more information at tulatubes.com or give us a call to schedule your consultation today!