What Is the TULA System?
Ear tube placement is one of the most common procedures performed on children in the United States, with approximately 700,000 surgeries performed every year. Traditionally, this required a trip to the operating room, general anesthesia, fasting beforehand, and separation from parents during the procedure.
The TULA System changes all of that.
TULA is an innovative, FDA-approved system that allows our board-certified pediatric ENT surgeons to place ear tubes right here in our office while your child is awake, comfortable, and by your side. Instead of general anesthesia, TULA uses a gentle, needle-free process called iontophoresis to deliver numbing medication directly to the eardrum. The medication is similar to what a dentist uses, but without any injections.
Once the eardrum is numb, our surgeon uses a specialized one-click delivery device to place the ear tube in less than half a second. Most children return to normal activities, including school, play, and lunch, the same day.
Why Do Children Need Ear Tubes?
Children are especially prone to middle ear infections because of the size and angle of their Eustachian tubes. When infections become frequent or fluid builds up persistently behind the eardrum, it can affect:
- Hearing and speech development
- Sleep quality and behavior
- Attention and school performance
- Overall comfort and daily quality of life
Ear tubes, also called tympanostomy tubes, pressure equalization tubes, or PE tubes, create a tiny opening in the eardrum that allows fluid to drain, air to circulate, and infections to occur far less often. For many children, ear tubes restore normal hearing almost immediately.
Your Child May Be a Candidate for Ear Tubes If They Have:
- 3 or more ear infections within a 3-month period
- 4 or more ear infections within a single year
- Persistent fluid in the middle ear lasting 3 months or longer
- Hearing loss related to fluid buildup in the ear
- Speech or language delays linked to hearing difficulties
- Ear infections that do not clear with antibiotic treatment
How the TULA Procedure Works
The entire TULA procedure takes place in our office during a single visit and is typically completed in about 35 minutes. Here is what families can expect:
Step 1: Ear Exam and Preparation
Your child's doctor will examine both ears and fit your child for specially designed earplugs. The ear canals are gently cleaned to ensure the best possible results.
Step 2: Eardrum Numbing via Iontophoresis
The earplugs are filled with a numbing solution called TYMBION, a combination of lidocaine and epinephrine similar to what a dentist uses. A gentle, low-level electrical current helps the medication absorb into the eardrum over approximately 10 minutes. This current is painless and is often described as a mild tingling sensation. During this time, your child can watch videos, play with toys, or sit comfortably in your lap or by your side.
Step 3: Ear Tube Placement
Once the eardrum is fully numb, the doctor's assistant gently holds your child's head while our surgeon uses the TULA delivery device to place the ear tube. The actual tube insertion takes less than half a second. The tube is similar in size and function to those used in the operating room.
Step 4: You Both Go Home
Once both ears are complete, your doctor will do a final check and your family is free to leave right away. No recovery room. No grogginess. No waiting.
Important: Your child does not need to fast before the TULA procedure. They can eat and drink normally and may even have a snack during the appointment.
TULA vs. Traditional Ear Tubes in the OR
| TULA In-Office | Traditional OR | |
|---|---|---|
| Location | Doctor's office | Operating room / hospital |
| Anesthesia | Local, needle-free | General anesthesia |
| Parent present? | Yes, throughout | Separation required |
| Fasting required? | No | Yes |
| Procedure time | About 35 minutes | Variable plus OR prep and recovery |
| Recovery | Immediate, same day | Grogginess, recovery period needed |
| Return to normal | Same day | Often next day or later |
| Safety record | Zero serious adverse events in clinical studies | Standard surgical risks apply |
Is TULA Right for My Child?
TULA is FDA-approved for children aged 6 months and older who have been recommended for ear tube placement. Our specialists will carefully evaluate your child to determine whether the in-office procedure is the right fit.
TULA May Be a Great Fit If Your Child:
- Has been recommended for ear tube placement by a physician
- Is able to wear earplugs and remain relatively still for a short time
- Does not have certain structural ear anatomy issues that limit access
- Does not have a known sensitivity or allergy to lidocaine or other local anesthetics
- Does not rely on electrically sensitive medical implants, such as a pacemaker
If the in-office procedure is not successful, whether due to the numbing medication being insufficient or your child being unable to remain still, we may reschedule for a traditional procedure in the operating room. Our team will always explain all options clearly and help you make the most informed choice for your child.
Clinical Results You Can Trust
The TULA System has been studied extensively in a prospective, multicenter clinical trial involving 337 children aged 6 months to 12 years. The results demonstrate a strong record of safety and effectiveness:
- 87% procedural success rate overall (86% in children under age 5; 89% in children ages 5 to 12)
- 95% of parents were very satisfied with the TULA experience
- Zero serious device, drug, or procedure-related adverse events in the entire study
- No sedation, anxiolytics, or mechanical restraints were required
- Tubes remain in place for an average of 16.8 months, comparable to OR-placed tubes
- 96.5% of ears with effusion at the time of the procedure were clear at the 3-week follow-up visit
These findings were published in the Laryngoscope, one of the leading peer-reviewed journals in otolaryngology and head and neck surgery.
Insurance Coverage for TULA
Tampa Children's ENT works hard to make TULA accessible to as many families as possible. The TULA procedure is billed under CPT code 0583T. Below is a current summary of insurance coverage:
| Insurance Plan | Coverage Notes |
|---|---|
| Anthem | Covered |
| Cigna | Covered (approx. 50% of billed charges; varies by contract) |
| Florida Blue | Covered (includes Seminole and Memorial plans) |
| United Healthcare | Covered when medical necessity is met; prior authorization with medical records recommended |
| Florida Medicaid | Covered (Simply, Aetna Better Health, Sunshine Health, Humana, and others) |
Coverage and reimbursement can vary based on your specific plan and contract. We strongly encourage you to call our office before scheduling so our team can help verify your benefits, walk you through your options, and assist with any prior authorization that may be required. We never want insurance to stand in the way of care your child needs.
Please note: Not all insurance plans cover CPT code 0583T at this time. Our team will review your plan before your appointment and be fully transparent about what to expect cost-wise. Call us at (813) 262-1330 to check your coverage.
Why Choose Tampa Children's ENT for TULA?
Tampa Children's ENT is one of a select group of pediatric ENT practices in the Tampa Bay Area offering the TULA System. Our surgeons are board-certified, fellowship-trained pediatric otolaryngologists who have completed comprehensive hands-on TULA training, both on-site and remotely, before performing their first procedure.
Every TULA procedure at our clinic is performed by a specialist who has dedicated their entire career to caring for children. You can trust that your child is in experienced, prepared, and confident hands.
When You Choose Tampa Children's ENT for TULA, You Get:
- Fellowship-trained pediatric ENT surgeons with comprehensive TULA-specific training
- A child-friendly office environment designed to keep your child calm and comfortable
- The ability to stay by your child's side throughout the entire procedure
- Clear guidance before, during, and after the appointment so you always know what to expect
- Same-day return to normal activities for most children
- Same-week and same-day appointment availability across our Tampa Bay Area locations
Ready to See If TULA Is Right for Your Child?
If your child has been dealing with repeated ear infections or persistent fluid in the ear, TULA may offer the relief they need without the stress of the operating room.
Call us at (813) 262-1330 to speak with our team, verify your insurance coverage, and schedule a consultation with one of our pediatric ENT specialists. Same-day and same-week appointments are available. We are here when your child needs us.
Your child's health and comfort are our priority. Let us help them feel their best.
Frequently Asked Questions (FAQs)
Most children tolerate TULA very well. The iontophoresis phase produces a mild tingling sensation. Once the eardrum is numb, tube insertion takes less than half a second and is not felt.
The appointment is typically completed in about 35 minutes, which includes ear preparation, the numbing process, tube placement, and a final check before you leave.
Yes. You remain with your child throughout the entire TULA procedure. Your child can sit in your lap or beside you while the eardrum is being numbed.
No fasting is required. Unlike procedures involving general anesthesia, your child can eat and drink normally before the appointment and may even snack during it.
Most children return to school, daycare, and normal play activities the same day as the procedure, with no grogginess or recovery period needed.
If local anesthesia is ineffective or your child cannot stay still, we may reschedule for OR-based tube placement. Our team will explain all options clearly and support your decision.
Yes. TULA is FDA-approved for children as young as 6 months. In clinical studies, children under age 5 had an 86% procedural success rate with zero serious adverse events reported.
Call our office at (813) 262-1330 before scheduling. Our team will verify your coverage, clarify costs, and handle any prior authorization required for your specific plan.