Otitis media is one of the most common illnesses among children, affecting approximately 25% of children in the first year of life and 50% of children by 3 years of age. It is the most common reason for an antibiotic prescription in children in the United States. ^, Tympanostomy tube (TT) placement is indicated when there is persistent middle ear effusion (MEE), frequent acute otitis media (AOM), or otitis media refractory to medical therapy. TT placement allows ventilation of the middle ear space. It is the most common ambulatory procedure performed in children, with an estimated occurrence of at least 400,000 per year in the United States alone.

In older children and adults, the procedure is often performed in the office setting using local anesthetics. Phenol (carbolic acid) is commonly used to create a partial-thickness chemical burn, which results in local anesthesia of the tympanic membrane (TM). Other, less frequently used options include EMLA cream (a eutectic mixture of local anesthetics, lidocaine 2.5%, prilocaine 2.5%), lidocaine injections, Bonain’s solution (cocaine hydrochloride, menthol, and phenol), and tetracaine injections. ^, These techniques have not been appropriate for younger children in the absence of mechanical restraint due to limited cooperation, discomfort, and a long onset time. Additionally, these local anesthetics are not approved for use on the TM by the Food and Drug Administration (FDA), and ototoxic effects of phenol and EMLA have been reported.

Therefore, in young children, TT placement is almost always done in the operating room under general anesthesia (GA). The risks associated with GA in children undergoing TT placement include laryngospasm, airway obstruction, oxygen desaturation, dysrhythmia, postoperative emesis, and postoperative delirium. ^, There is also increasing concern about the impact on neurodevelopment from GA. One study reported that children who underwent GA before age 3 years were 1.9 times more likely to have a language disability and 1.7 times more likely to have a cognitive disability. Similarly, another study showed that multiple exposures to GA by age 4 years increased the risk of learning disability compared to a single exposure or no exposure. However, a more recent study showed that a single, brief anesthetic exposure during early infancy does not alter neurodevelopmental outcomes compared to awake regional anesthesia. These studies are important to consider as most TT placements are performed at neurodevelopmentally important ages, and around 20% of children will have a second TT placement. Performing this procedure in the operating room under GA also increases the recovery time, can be disruptive to a child and their caregiver with time off from school and work, and can cause distress with preoperative fasting. Additionally, this places a significant economic burden on the healthcare system.

These factors have led to increased interest in performing TT placement in the office setting under local anesthesia. In 2019, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) published a position statement advocating for in-office TT placement for awake children when appropriately selected using shared decision making between the provider and caregiver. Similarly, this position was reinforced in a state-of-the-art review from the AAO-HNS in 2022.

A new technology (Tula System; Smith & Nephew) was created to allow safe and reliable TT placement in the office setting using local anesthesia. It accomplishes this by applying iontophoresis to administer local anesthetic (2% lidocaine/1:100,000 epinephrine; TYMBION; Smith & Nephew) to the TM, followed by an automated tube delivery system that integrates myringotomy and tube placement. ^, TT placement in children is typically performed using short-term grommet tubes, including Armstrong, Donaldson, Paparella I, Reuter Bobbin, Shah, Sheehy, and Shepard tubes. ^, The Tula Tympanostomy Tube is similarly a grommet-style silicone tube with a 1.14 mm inner diameter ( Fig. 51.1 ). This system received approval by the US FDA in 2019 for patients ages 6 months and older. ^,

Tula Tympanostomy Tube dimensions.

(Used with permission from Smith & Nephew, Inc.)

Tula Tympanostomy Tube insertion is a multistep process using highly specialized equipment. A dedicated team working with Child Life experts greatly assists in successful outcomes. Overall procedure time varies but averages 33 minutes per patient. Local anesthesia is applied to the TM using the Tula Iontophoresis System (IPS) through iontophoresis of an otic solution containing 2% lidocaine HCL and 1:100,000 epinephrine ( Fig. 51.2 A and B). The IPS applies a low-level electrical current (0.8 mA) to mobilize the ions of the otic solution, which accelerates tissue uptake. Specialized earplugs are used to optimize contact between the otic solution and the TM, while allowing patient mobility. Therefore, the patient should not require sedatives or anxiolytics. Patients undergoing bilateral TT placement can undergo simultaneous, bilateral iontophoresis. This process takes approximately 10–15 minutes. Anesthesia is confirmed by lightly touching the TM with a dull otologic instrument. Once the TM is anesthetized, the otic solution is drained by gravity or a wick. ^,

The Iontophoresis System earset (A). The Tula Iontophoresis System Control Unit (B).

(Used with permission from Smith & Nephew, Inc.)

The tube delivery system.

(Used with permission from Smith & Nephew, Inc.)

Tube delivery is accomplished using the Tula Delivery System (TDS). The TDS is a hand-held device that automates rapid myringotomy with tube placement while enhancing safety due to its inherent features and sheathed blade. The tip of the TDS is held at the anesthetized TM, and a button permits myringotomy with tube placement in less than 0.5 seconds. The myringotomy blade is within the device and is uncovered for less than 0.25 seconds, ^, maximizing safety during the procedure.

A prospective, single-arm study was performed, consisting of 337 pediatric patients, to evaluate 2-year outcomes following iontophoresis and an automated tube delivery system. Sixty-eight patients had the procedure performed in the OR, while 269 had the procedure performed in the office. The procedural success endpoint was predetermined to be 68% based on a patient preference study by a health economics research firm that determined parents would prefer the in-office Tula TT placement over the traditional OR-based TT placement under GA if the procedure had a success rate of at least 68%. Success rate was 85.8% in children less than 5 years old and 89.2% in those between 5 and 12 years old. At 3 weeks, 99.7% of tubes were in the TM, with 91.7% at 6 months, 67.1% at 12 months, 39.1% at 18 months, and 22.7% at 24 months. The estimated median and mean times to tube extrusion were 15.82 and 16.79 months, respectively. ^,

Treatment failures were associated with behavior/movement (5.0%), inadequate anesthesia (3.2%), discomfort/anxiety (1.8%), anatomic challenges (1.4%), iontophoresis intolerability (0.9%), and partial tube medialization (0.5%). One patient had an unsuccessful tube placement due to oversized myringotomy; this was thought to be due to a weakened TM in the setting of an AOM at the time of the procedure. One patient had a tube that was placed in a medial position, which was then corrected with a pick at a follow-up visit. For the one patient who had a tube that was deployed medial to the TM and could not be retrieved, there were no clinical sequela from this within the study period.

The Faces Pain Scale–Revised (FPS-R) mean score, used to assess pain in patients 5–12 years old, was 3.3 on a scale of 0 (no pain) to 10 (very much pain). This met the study’s predefined endpoint of tolerability, requiring the mean FPS-R score to be less than 4.2, chosen based on published cut-off points for no, mild, moderate, and severe pain. ^, The median FPS-R score was 2.0. The mean FPS-R score 5 minutes after the procedure ended was 1.7; the median was 0.0.

Parental satisfaction was assessed at a 3-week follow-up visit. Ninety-five percent of parents strongly agreed with the statement, “Overall, I am very satisfied with the in-office ear tube procedure” (n = 201). Ninety-four percent of parents strongly agreed or agreed with the statement, “If my child (or a sibling) needed ear tubes again, I would choose this procedure in the office instead of going under general anesthesia in the operating room” (n = 202). Seventy-five percent of parents reported that their child returned to their normal activities immediately following the procedure.