By: Conn Hastings, Medgadget
In the United States approximately 1 million children undergo ear tube placement every year. The tubes are typically needed when there’s excess fluid in the middle ear and to address chronic ear infections. The tubes help to prevent this fluid build-up but require placement under general anesthesia.
General anesthesia can be distressing for children and parents, and Preceptis Medical, a medtech company based in Minnesota, has developed an in-office solution for ear tube placement that requires only a local anesthetic. The Hummingbird device allows an ENT surgeon to place an ear tube in a single pass, and provides a convenient and less expensive option for ear tube placement.
A multicenter study recently investigated the safety, tolerability, and efficacy of the approach, and the results were published in journal Laryngoscope Investigative Otolaryngology.
Medgadget had the opportunity to speak with Steve Anderson, Preceptis Medical’s CEO, about the Hummingbird and the latest study results.
Conn Hastings, Medgadget: Please give us an overview of ear tubes and the reason they are inserted.
Steve Anderson, Preceptis Medical: Ear tubes, also called tympanostomy tubes (TT), are the primary surgical treatment option for children that have persistent fluid buildup in their middle ear and/or chronic middle ear infections.
If left untreated, these infections can lead to hearing loss that can result in delayed speech development and poor school performance. During the procedure, tiny cylinders are implanted to create an airway that ventilates the middle ear and prevents the accumulation of fluids behind the eardrum. The tubes usually fall out on their own six to twelve months after the procedure and the holes will heal on their own.
Medgadget: What are the limitations associated with how the tubes are currently inserted?
Steve Anderson: Approximately one million children undergo ear tube procedures annually in an operating room in the United States alone. These procedures are done under general anesthesia due to the surgical limitations and pain associated with using standard instruments to treat children.
Ear tube procedures conducted in an operating room can be traumatic for both children and parents well before the procedure begins and after it ends. Preoperative fasting to avoid reactions to general anesthesia can increase the child’s anxiety about the procedure. It is also estimated that 57% of children experience post-general anesthetic delirium symptoms, such as restlessness, agitation, thrashing, crying or moaning, and disorientation.
Medgadget: Please give us an overview of the Hummingbird device, and how it works.
Steve Anderson: The FDA-cleared Hummingbird Tympanostomy Tube System (TTS) is a breakthrough pediatric technology that reduces surgical trauma for patients and enables safe and efficient in-office ear tube placement for children. The Hummingbird is proven to eliminate the need for general anesthesia with 99% procedure success in the office.
The Hummingbird TTS allows ENT surgeons to provide parents and their children a safe, convenient, and less expensive option for pediatric ear tube procedures by eliminating the need for general anesthesia and an operating room.
The Hummingbird creates an incision and places an ear tube in one single pass. The device combines the separate steps and tools for making an incision, positioning the ear tube, and placing the tube using standard instruments required for traditional procedures. Using the Hummingbird, an incision is made using the cutting sheath at the tip of the device and the tube is placed by scrolling back on the slider.
With the Hummingbird, ear tube procedures are completed right in the comfort of the doctor’s office using only a topical anesthetic to numb the eardrum. The office-based procedure takes about five minutes, and parents can stay in the room with their child to provide further comfort. Children recover quickly and can return to normal activities immediately following the procedure.
Medgadget: How was the device conceived and designed? What inspired Preceptis Medical to develop such a solution?
Steve Anderson: Preceptis Medical was founded by parents, including a pediatric anesthesiologist, who wanted to design products focused on improving the lives of children. The founders understood the stress and costs associated with putting young children to sleep for surgery. They developed the Hummingbird in partnership with leading pediatric ENTs to simplify ear tube procedures while reducing the risks associated with the use of general anesthesia in children. The company’s goal is to broaden the options available to ENTs and parents, focusing on the safety and comfort of the child, while reducing healthcare costs.
Medgadget: Is the device easy to use? Does it require much training before a clinician can use it?
Steve Anderson: The device was designed collaboratively with pediatric ENTs to be straightforward for ENT surgeons to learn to use. Surgeons are trained on the Hummingbird in the comfort of their office on a simulated head model. The surgeons are then observed over a series of in vivo cases to complete the certification requirements.
The device’s simplicity is a key reason why interest from both surgeons and parents has been very strong, further reinforcing the unmet need and desire for alternative options to procedures performed in the operating room.
Medgadget: Please give us an overview of your recent published study assessing the safety, tolerability, and efficacy of the approach.
Steve Anderson: Results from a prospective, multicenter study assessing in-office pediatric ear tube placement using the Hummingbird were recently published in Laryngoscope Investigative Otolaryngology. The study showed that ear tube placement with the Hummingbird device in awake young children using only a topical anesthetic was safe, successful, and well tolerated.
The study enrolled 211 children age 6–24 months who were treated at 10 sites by 13 ENT investigators. TT placement was successfully and safely completed in the office setting in 99% of cases for this age group, with a median intraoperative procedure time of fewer than five minutes for bilateral TT placement. Tolerability of the procedure was validated by assessments from the ENT surgeons and their staff members, as well as procedure reviews from independent clinicians.
Additionally, a survey showed that 97% of parents with children treated with the Hummingbird would recommend the procedure to other parents. Further, the American Academy of Otolaryngology released a Position Statement supporting in-office TT placement in appropriate children.
With the results of the study, strong interest from ENT surgeons, and favorable feedback from parents, Preceptis believes that in-office ear tube procedures may become the standard of care for pediatric ear tube placement.