New System Facilitates Tympanostomy Tube Delivery

An innovative tympanostomy (ear tube) delivery system enables placement of tubes in the comfort of an office environment.

The Tusker Medical (Menlo Park, CA, USA) Tubes Under Local Anesthesia (Tula) system is designed to enable delivery of an ear tube to patients under local anesthesia in a physician's office setting, obviating the need for general anesthesia. The system is composed of four concentric components that cut, dilate, shield, and stabilize. The cutter first creates the myringotomy; the dilator opens the incision, while the shield introduces the tympanostomy tube through the myringotomy. The system is approved for use in both adults and children as young as six months of age.

To facilitate painless delivery, an iontophoresis device is used to deliver a low-level electrical charge to the tympanic membrane in order to accelerate uptake of a local anesthetic (Tymbion) into the ear drum, providing needle-free local anesthesia. The automated tube delivery system then provides single-button insertion of a preloaded Grommet tympanostomy tube through the myringotomy. The cutter is exposed only for the very brief moment (less than 500 milliseconds) when the myringotomy is created, and is otherwise recessed within the device, an important safety feature when performing procedures in an awake child.

“The Tusker Iontophoresis System uses a small amount of electrical current to accelerate the uptake of the local anesthetic into the tympanic membrane,” said Amir Abolfathi, president and CEO of Tusker Medical. “This provides an alternative to phenol (a denaturing acid), ear canal injections, or other local anesthesia methods, none of which have FDA approval for pediatric tympanic membrane anesthesia and are often painful or take an unacceptably long time to achieve anesthesia.”

Otitis media is inflammation of the middle ear that occurs in the area between the tympanic membrane and the inner ear, including a duct known as the eustachian tube. Though painful, otitis media is not threatening and usually heals on its own within 2–6 weeks. In chronic cases with effusions, insertion of a tympanostomy tube into the eardrum reduces recurrence rates in the six months after placement, but has little effect on long term hearing. The tubes are recommended in those who have more than three episodes of acute otitis media in 6 month or 4 in a year associated with an effusion.