Preceptis Medical, a medtech company based in Minnesota, created the Hummingbird Tympanostomy Tube System. The device allows ear, nose, and throat (ENT) surgeons to insert ear tubes in the comfort of their office. The procedure requires only local anesthetic and is intended to be less distressing for pediatric patients than the conventional approach, which requires general anesthesia.
The Hummingbird device provides a “one-pass” approach to ear tube placement, with an ear drum incision and tube placement occurring with a few simple manipulations of the device. Medgadget spoke with Steve Anderson, CEO of Preceptis Medical, back in March 2021. Since then, the Hummingbird system has received FDA clearance for an expanded indication in all children aged 6 months and up.
Medgadget had the opportunity to speak with Greg Mielke, Chief Commercial Officer at Preceptis Medical, about the technology and what the latest FDA clearance meant for the company.
See a video demonstrating the procedure below.
Conn Hastings, Medgadget: Please give us some background on fluid build-up and infections in the middle ear, and their consequences for pediatric patients.
Greg Mielke, Preceptis Medical: Today, approximately one million children undergo ear tube procedures annually in an operating room in the United States. Ear tubes are the primary surgical treatment option for children that have persistent fluid buildup in their middle ear and/or chronic middle ear infections. Ear fluid buildup and middle ear infections (also known as otitis media) happen due to swelling in the eustachian tubes, which allow mucus to drain from the middle of the ear into the throat. Swollen eustachian tubes can be caused by a cold, allergies, or acid reflux, and fluid can build as the virus or bacteria grow. Otitis media generates about 25 million annual office visits to general physicians and pediatricians, with the highest prevalence occurring in children 3-6 months.
If left untreated or if the fluid buildup reaches a high enough level, the eardrum can rupture. Fluid buildup and middle ear infections can also lead to hearing loss that can result in delayed speech development and poor school performance.
Medgadget: Please give us an overview of the technology and how it works.
Greg Mielke: The groundbreaking Hummingbird Tympanostomy Tube System enables ear, nose and throat (ENT) surgeons to provide parents and their children a safe and less expensive option for pediatric ear tube procedures in the convenience of the ENT’s office.
The Hummingbird device combines the separate steps of making a myringotomy (an incision created in the eardrum to relieve pressure caused by excessive buildup of fluid) while positioning the pressure equalizer tube and placing the tube using alligator forceps or picks. Using Preceptis’ patented One-Pass® technology, an incision is made, and the tube is placed by scrolling back on the slider. A topical anesthetic helps numb the eardrum and the entire procedure is completed efficiently in the office.
Medgadget: How does the procedure compare with conventional tube placement in terms of convenience, patient stress/comfort, ease of use, and speed?
Greg Mielke: Traditionally, ear tube procedures have been performed under general anesthesia due to the surgical limitations and pain associated with using standard instruments to treat children. However, ear tube procedures conducted in an operating room under general anesthesia can be traumatic for both children and parents well before the procedure begins and after it ends. It is reported that 57% of children with ear tube procedures experience post-general anesthetic emergence delirium (e.g., restlessness, agitation, thrashing, crying or moaning, and disorientation) and require a minimum of three minutes of physical restraint. There are also potential safety concerns about the use of general anesthetics in very young children, which prompted an FDA Safety Alert in 2016. Conventional ear tube placement can also be costly due to the use of anesthesia and the operating room environment.
The Hummingbird device is an innovative pediatric technology that reduces surgical trauma for patients, enabling safe and efficient in-office ear tube placement for children. Hummingbird allows clinicians to make an incision and place an ear tube in one single pass. It combines the separate tools and steps performed in standard ear tube procedures into a comprehensive one-pass device. Ear tube procedures using the Hummingbird device are completed right in the comfort of the doctor’s office using only a topical anesthetic to numb the eardrum, and parents can attend the procedure with their child to provide further comfort. Shifting the procedure to the doctor’s office enables the same surgery and clinical outcomes of conventional ear tube surgery at a safe, efficient, and less expensive site of care. Also, children recover quickly and can return to normal activities immediately following the procedure. We believe the Hummingbird device overcomes many obstacles associated with conventional tube placement as it was developed by parents with their children in mind.
Medgadget: Congratulations on the recent FDA clearance to use the system in all children 6 months and up. What impact will this have on the adoption of the technology?
Greg Mielke: The recent U.S. FDA clearance for expanded indication was an exciting accomplishment as we are now able to offer our clinically-proven device to more eligible pediatric patients. The device is now cleared for all eligible patients over six months of age, which expands our addressable market by over 50%. Additionally, the clinical evidence we accumulated for the application of the expanded label may increase adoption of the Hummingbird device. We anticipate more pediatricians and ENTs to be intrigued and motivated to use this device as it is now more applicable and proven even further to be safe and effective.
Medgadget: How has the system been received to date? Have clinicians enjoyed being able to provide this treatment in an office?
Greg Mielke: The Hummingbird device has been well received to date as ENTs and pediatric patients continue to experience successful outcomes. Many of the pediatric otolaryngologists that we’ve recently spoken to have expressed excitement and gratitude for a solution that simplifies ear tube procedures while reducing the use of general anesthesia in children.
We also received positive feedback and recommendations from parents in our clinical studies. It is very rewarding to continue to hear favorable remarks about our device and the impact it has on the physician and patient community. With proven results, strong interest from ENT surgeons, and favorable feedback from parents, we believe in-office ear tube procedures may become the standard of care for pediatric ear tube placement.
Medgadget: Where is the system available at present? Do you have any plans to expand to other markets?
Greg Mielke: The Hummingbird device is FDA cleared and commercially available in the U.S. We are currently focused on addressing the current product demand and increasing patient access in collaboration with the insurance community. However, we look forward to the possibility of extending the use of the Hummingbird device worldwide.
Medgadget: Do you have any plans to develop other medical technologies or further develop the Hummingbird system? Where do you see these types of technologies progressing?
Greg Mielke: The Hummingbird device has the potential to become the standard of care for pediatric ear tube procedures. We are excited to be at the forefront of advancements for pediatric patients, and we expect ENT technology to evolve to confront the unmet need of safe, comfortable, and cost-effective solutions to common pediatric ENT conditions.