How the New Tube Delivery Systems Work
Tula is a two-part system: Local anesthesia is delivered by a unique iontophoresis system (which includes individually fitted disposable ear plugs, ear sets, and Tymbion, a lidocaine and epinephrine solution that’s specifically FDA approved for use with the Tula System) and the tube insertion device, which creates an incision in the tympanic membrane and places the tube.
Explore This IssueSeptember 2020
The tube placement device is “very user friendly,” said John Gavin, MD, an otolaryngologist in private practice in Albany, N.Y., who participated in the clinical trials. The iontophoresis system, he said, can be a bit trickier.
“You have to make sure you get a good seal around the device to deliver the medication into the ear. You also have to be really careful to ensure that you don’t have air in the ear canal during iontophoresis, because then you may not achieve adequate anesthesia,” Dr. Gavin said.
Parents or guardians should be with the child throughout the procedure. They can play games with or otherwise distract the child during the numbing process and can hold and comfort the child during tube placement.
Placing the tympanostomy tubes using the device is a one-step procedure. “You just press a button, and an incision is made simultaneously with tube placement. It’s very fast,” Dr. Moss said. However, there is a learning curve.
“When you try to deploy the tube, if you don’t have the device lined up just right, the tube can bounce off the eardrum back into the ear canal; it doesn’t actually end up where you want it to be,” said Scott Schoem, MD, head of otolaryngology at Connecticut Children’s Medical Center in Hartford. “It takes a little bit of practice to get the right angle, to position it properly before you engage the device,” he said.
The entire procedure—from anesthetizing through tube deployment—takes approximately 40 minutes. A clinical trial found that physicians were successful in placing ear tubes in 86% of children (103/120) ages 6 months to 4 years and 89% (92/102) of children ages 5 to 12 years. Twelve patients were determined to have inadequate anesthesia in one or both ears after iontophoresis. Thirteen patients reported mild ear pain, with six of those reports coming within the first postoperative month (Laryngoscope. 2020;130:S1-S9).
No serious adverse events were noted in the clinical trial. One patient experienced tongue numbness that lasted for hours after iontophoresis; one experienced iontophoresis-related erythema, and another reported pain at the site of the return electrode. Approximately 2% (5/269) experienced otitis externa and 0.4% (1/269) experienced tympanosclerosis, transient mild ear bleeding, transient mild tympanic membrane inflammation, ear pressure, and dermatographia (Laryngoscope. 2020;130:S1-S9).
Unlike Tula, the Hummingbird system doesn’t include a specialized anesthesia process. Instead, the physician applies local anesthetic to the eardrum using a swab. After sufficient numbing, the physician uses the patented Hummingbird one-pass device to make a myringotomy and place and position the ventilation tubes.
According to Steve Anderson, CEO of Maple Grove, Minn.-based Preceptis Medical, maker of the Hummingbird, a clinical study involving more than 200 children ages 6 to 24 months showed a 99% success rate for tube placement. Results posted on www.clinicaltrials.gov show a 100% success rate for 199 patients and 393 ears, with zero adverse events. Preceptis plans a commercial launch of the Hummingbird device in select markets in the second half of 2020.