1. The Tula® System
Is the Tula System safe?
Yes, The Tula System has been demonstrated as safe and effective in clinical studies.1,2
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.
2. The Tula Procedure
Can I stay with my child throughout the whole procedure?
Yes, that is one of the main benefits of the Tula System! By enabling the procedure to be performed in the doctor’s office without the need for general anesthesia, you can now remain by your child’s side. You may be asked to comfort your child by holding their hand, providing a reassuring touch, or a big “bear hug.”
How do you get the child to sit still?
You and the office staff play an important role and may be asked to help occupy and distract your child during the procedure with praises, videos, and/or your favorite games. Generally, if your child is able to remain still for a haircut or dental procedure, then he/she may be a good candidate. Ask your ENT doctor for a copy of the Tula Parent Guide for helpful tips on how to help your child through the procedure.
How long will my child need to sit still?
Your child will need to remain still while the physician fills your child’s ears with the numbing solution and places the ear plugs. Then he/she should be quietly occupied for about 10 minutes while the ears are numbing. During this time, your child can play with a toy, eat snacks, or watch a movie, but should not touch the ear plugs or cables.
Your child will also need to remain still for the insertion of the ear tubes. The doctor’s assistant will hold your child’s head during this portion of the procedure to limit movement.
How long does the actual tube insertion take?
Once the doctor establishes visualization of the ear drum, the Tula tube delivery device will insert the ear tube in less than half a second per ear to minimize the time your child must remain still.6
Will my child feel any pain during tube insertion?
The ENT doctor will make sure the numbing drug is working by gently tapping each eardrum before proceeding with the ear tube insertion. Your child will likely not feel this but will hear a “tap, tap, tap.”
During tube insertion, some participants have reported hearing a loud sound. In the Tula clinical study, children ages 5-12 years were asked to report any pain. Most children reported experiencing only “mild pain” immediately after tube insertion, which faded to “no pain” five minutes after ear tube insertion.2,3 There was a minority of children who reported greater than mild pain when the tubes were placed. If you are concerned about how the procedure may feel, please discuss these concerns with your doctor.
How does the doctor know the numbing fluid worked?
The ENT doctor will gently tap each eardrum with an instrument and assess your child’s reaction to be sure that your child’s ear drum is numb prior to ear tube insertion. In the recent Tula clinical study, the ear drum was not fully numb for approximately 3% of children.2 If this happens, the ENT doctor will not proceed with the procedure.
What if my child just would not sit still or becomes agitated during the procedure?
It is always okay to stop the procedure and reschedule your child for ear tube placement in the operating room. Your ENT doctor will be monitoring your child’s comfort level and will make recommendations for the best course of action.
Are ENT doctors able to successfully place ear tubes in-office, using the Tula System, most of the time?
Yes, ENT doctors were successful in the majority of cases. In the recent Tula clinical study, ENT doctors successfully placed ear tubes in 86% of children ages 6 months-4 years and in 89% of children ages 5-12 years.2
If ear tube placement in-office is not successful, your child may be rescheduled for ear tube placement in the operating room. Your ENT doctor will recommend the best course of action.
3. After the Procedure
When can my child return to school or normal activities after the procedure?
You and your child will be able to leave the office directly after the procedure. Most children return to normal activities immediately following the procedure. 2
When will the ear tubes fall out?
Typically, ear tubes will stay in the eardrum for six months to two years, before falling out on their own. In some cases, the ear tube falls out too soon, and another needs to be put in.4 Your ENT doctor will recommend the best course of action. For context, in the recent Tula clinical study, 75% of Tula ear tubes remained in place for at least one year.5
If a tube doesn’t fall out, your child’s ENT doctor will evaluate whether it needs to be surgically removed.
References
2 Lustig LR, Ingram A, Vidrine M, et. al. In‐Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery. Laryngoscope 130; S1-S9, 2020.
3 Tsze DS, Hirschfeld G, Dayan PS, et. al. Defining No Pain, Mild, Moderate, and Severe Pain Based on the Faces Pain Scale-Revised and Color Analog Scale in Children with Acute Pain. Pediatric Emer Care 34(8); 537–544, 2016.
4 American Academy of Otolaryngology-Head and Neck Surgery: https://www.enthealth.org/be_ent_smart/ear-tubes
5 Tula Pivotal study interim data. 12-month retention by ear. N=290. Data on file.
6 The procedure typically lasts about 35 minutes. Tula Pivotal Study. Data on file.
The information presented about the Tula System is for educational, informational, and illustrative purposes only. It does not constitute and is not a substitute for medical advice and does not provide any indication, guide, or guarantee as to the response a child may have during a Tula System procedure.