Medical precept, a Minnesota-based medical technology company, created the Hummingbird Tympanostomy Tube System. The device allows ear, nose and throat (ENT) surgeons to insert ear tubes from the comfort of their office. The procedure requires only local anesthesia and is intended to be less painful for pediatric patients than the conventional approach, which requires general anesthesia.
The Hummingbird device offers a “one pass” approach to ear tube placement, with an incision of the eardrum and tube placement occurring with a few simple manipulations of the device. Medgadget spoke with Steve AndersonCEO of Preceptis Medical, in March 2021. Since then, the Hummingbird System has received FDA clearance for an expanded indication in all children 6 months of age and older.
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 provide some information on fluid accumulation and infections in the middle ear, and their implications for pediatric patients.
Greg Mielke, Preceptis Medical: Today, approximately one million children undergo ear procedures each year in an operating room in the United States. Ear tubes are the primary surgical treatment option for children who have persistent fluid buildup in their middle ear and/or chronic middle ear infections. Fluid buildup in the ear and middle ear infections (also called otitis media) are caused by swelling of the Eustachian tubes, which allows 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 up as the virus or bacteria grows. Otitis media generates around 25 million annual visits to general practitioners and paediatricians, with the highest prevalence occurring in children aged 3 to 6 months.
If left untreated or if the fluid buildup reaches a high enough level, the eardrum can rupture. Fluid accumulation and infections in the middle ear can also lead to hearing loss which can lead to delayed speech development and poor academic performance.
Medgadget: Please give us an overview of the technology and how it works.
Greg Mielke: The revolutionary Hummingbird Tympanostomy Tube System enables ear, nose, and throat (ENT) surgeons to offer parents and their children a safe, less expensive option for pediatric ear tube procedures from the comfort of the ENT office.
The Hummingbird device combines the separate steps of performing a myringotomy (an incision created in the eardrum to relieve pressure caused by excessive fluid buildup) while positioning the pressure-equalizing tube and placing the tube at the using alligator clips or picks. Use of Preceptis’ patented One-Pass® technology, an incision is made and the tube is placed by scrolling backwards over the slider. A topical anesthetic helps numb the eardrum and the whole procedure is done efficiently in the office.
Medgadget: How does the procedure compare to 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 performed in an operating room under general anesthesia can be traumatic for children and parents long before the procedure begins and after it is completed. It has been reported that 57% of children undergoing ear tube surgery experience emergence delirium after general anesthesia (eg, restlessness, restlessness, thrashing, crying, or moaning and disorienting) and requiring minimal three minutes of physical restraint. There are also potential safety concerns regarding the use of general anesthetics in very young children, which triggered 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 a single pass. It combines the separate tools and steps performed in standard ear tube procedures into a complete, single-pass device. Ear tube procedures using the Hummingbird device are performed in the comfort of the doctor’s office using only topical anesthetic to numb the eardrum, and parents can attend the procedure with their child for added comfort. Transferring the procedure to the doctor’s office provides the same surgical and clinical results as conventional ear tube surgery in a safe, efficient, and less expensive site of care. In addition, children recover quickly and can resume normal activities immediately after the procedure. We believe the Hummingbird device overcomes many of the barriers associated with conventional tube placement because 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 older. What impact will this have on technology adoption?
Greg Mielke: The recent US FDA clearance for an expanded indication was an exciting achievement 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, expanding our potential market by more than 50%. Additionally, the clinical evidence we have accumulated for expanded label enforcement may increase adoption of the Hummingbird device. We anticipate that more pediatricians and ENTs will be intrigued and motivated to use this device as it is now more applicable and proven to be even safer and more effective.
Medgadget: How has the system been received so far? Did clinicians like being able to provide this treatment in a practice?
Greg Mielke: The Hummingbird device has been well received to date as ENT and pediatric patients continue to see good results. Many pediatric otolaryngologists we spoke to recently expressed their excitement and gratitude for a solution that simplifies ear tube procedures while reducing the use of general anesthesia in children.
We have also received positive feedback and recommendations from parents in our clinical studies. It is very gratifying to continue to hear positive feedback 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 that in-office ear tube procedures could become the standard of care for pediatric ear tube placement.
Medgadget: Where is the system currently available? Do you have expansion plans to other markets?
Greg Mielke: The Hummingbird device is FDA cleared and commercially available in the United States. We are currently focused on meeting current product demand and improving patient access in collaboration with the insurance community. However, we look forward to the possibility of expanding 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 advancing?
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 expect ENT technology to evolve to meet the unmet need for safe, comfortable and cost-effective solutions to common pediatric ENT conditions.