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Did You Hear? Ear Tubes are Changing!

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Publishing Organization: Metagadget.com
Publishing Author: Conn Hastings, PhD

Innovation: Hummingbird Tympanostomy Tube System (TTS)
Company: Perceptis Medical
CEO: Steve Anderson

(Hastings, C. 2021.)

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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.

Link: Hummingbird TTS product page...

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Hummingbird Device for Ear Tube Placement: Interview with Steve Anderson, CEO of Preceptis Medical |

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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.

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2/2/2021

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With 700,000 to 1 million American children annually undergoing surgical intervention to manage recurrent infections of acute otitis media, tympanostomy tube placement is the most common pediatric surgical procedure performed using general anesthesia (Hastings, 2021; Truitt et al., 2021). To address parental concerns of general anesthesia, Preceptis Medical developed the Hummingbird Tympanostomy Tube System (TTS) to allow for this procedure to be performed in-office using local anesthetic (Hastings, 2021).

Standard tympanostomy tubes include either short-term grommets (metal, silicone, or fluoroplastic) or long-term tubes; their surgical placement from an otolaryngologist involves general anesthesia and the use of multiple tools to clear the ear canal, make an incision in the tympanic membrane, suction and irrigate the middle ear to remove any effusion, place, and finally position the ear tube (Issacson, 2020; Spaw and Camacho, 2022). The Hummingbird TTS is a “single pass delivery device” that is “safe, successful, and well tolerated;” when tested in children ages 6 months-2 years and 5-12 years, at 10 clinical sites, 98.7% of the children experienced successful ear tube placement using this device (Truitt et al., 2021).

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"Placing a grommet type tube" (Isaacson G., 2020).
Above images show all steps of standard tube placement practices under general anesthesia.

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Innovative Hummingbird insertion process (Preceptis Medical, 2019).

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"Tympanostomy tube used with the Hummingbird Tympanostomy Tube System" (Truitt et al., 2021). 

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· Avoidance of acute general anesthesia complications, as well as long term behavioral or developmental risks, through use of topical anesthesia (Truitt et al., 2021).

· Successful use of various topical anesthesia would also accommodate for various patient allergies

· Rapid procedure time; tube placement achieved in mostly a single pass in 84.4% of all studied cases; completed in two instrument passes in 98.2% of the studied cases (Truitt et al., 2021) Average placement time was 4 minutes and 53 seconds (Truitt et al., 2021).

· Decreased recovery time; 94.3% of children studied were classified as calm and/or no inappropriate crying upon being reunited with parents (Truitt et al., 2021).

· Can be successfully performed on awake child, when immobilized with use of protective restraint in younger children and optional restraint with older compliant children; Clinicians reported placement procedure was “tolerated acceptably” by the pediatric patients (Truitt et al., 2021).

· Patents could opt to be present during procedure to assist with calming and distracting their child, at discretion of otolaryngologist; this occurred in 66.8% of the cases studied (Truitt et al., 2021).

· Decreased cost and scheduling inconveniences in this office alternative opposed to surgery in an Operating Room (Truitt et al., 2021).

· No dietary restriction required prior to procedure (Truitt et al., 2021).

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· Limited access to this alternative as it is not offered by all providers.

· Potential for procedure to have limited coverage by insurance if patient has to go to out of network clinics, or if newer procedure is not approved by all insurance companies.

· Learning curve for providers of this skill; newer procedure, and historically “much of clinical practice is guided by shared experience” (Issacson, 2020).

· Questionable tolerance; evaluation of the child’s tolerance did not include feedback from the parents or older verbal children, but was determined by clinician (Truitt et al., 2021).

· Procedure may fail and required standard intervention under general anesthesia with cases of anatomical challenges or patient movement (Truitt et al., 2021).

· Adverse events include: tube extrusion and tube dislocation during placement if patient is not properly restrained (Truitt et al., 2021).

· Other risks (that are also standard of all ear tubes): clogging, lost inside middle ear, limited duration of function, infection, persistent perforation, retention (Issacson, 2020).

· Incomplete evidence due to study limitations below: (Truitt et al., 2021)

A-Not tested in children between 2-5 years old.

B-Investigator excluded children with developmental delays, bleeding risks, or other conditions they decided placed patient at greater risk.

C-Study excluded children who had previous ear tubes when they were age 6months-2 years.

D-Does not account for long term use; study listed follow up data from 3-10 weeks post op, but not any further

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While not a perfect solution, in designing the Hummingbird TTS, Perceptis Medical has given parents a much needed alternative treatment option to standard tympanostomy tube placement and its associated general anesthesia risks.

In pediatric patients with chronic ear infections, it can be difficult to navigate and process sensory input when everything they hear is muffled. They may feel constantly off balance due to these ear infections causing a buildup of fluid behind their eardrum. Frequent Acute Otitis Media can even be associated with hearing loss, speech delays, or gross motor delays in infants as they are learning to speak and walk. Having various treatments available is helpful in their treatment and prevention of long term problems. Parents who might otherwise decline surgical intervention due to perceived and actual risks will now have a solution that is more aligned with their treatment goals. 95.1% of parents studied agreed an alternative treatment was important to them, and 97.5% stated they would recommend the Hummingbird TTS procedure to other parents (Truitt et al., 2021).

That said, more studying of this device is necessary before it can be championed as a full replacement for the standard intervention. Performance of a Randomized Control Trial comparing the Hummingbird TTS to the standard method of placing ear tubes and addressing the current limitation of the study, as addressed in the Cons section of this investigation, would improve the study validity in a more diverse pediatric population.

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Imagine what this would sound like to children with fluid buildup in their inner ears.

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Below are my top five strengths, and how they will help the team:

1. Input - Strategic Thinking

My pursuit of knowledge will help me in gathering and storing information to make well-informed decisions.

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My dedication and ownership to my commitments will help me deliver high quality outcomes.

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My desire for fairness and justice will help set predictable routines and clear boundaries.

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My authenticity in relationships built on mutual trust will help others feel valued

(Gallup, n.d., 2023).

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Go Deeper With the 34 CliftonStrengths Themes

To truly succeed using your CliftonStrengths, you need to move past their definitions and spend time developing them.

Our research finds that people who use their CliftonStrengths:

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Take the following steps to start using your CliftonStrengths themes to maximize your potential and become your best you.

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What Are the 34 CliftonStrengths Themes?

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Get definitions and learn ways to use each of the 34 CliftonStrengths themes popularized in StrengthsFinder 2.0 and Now, Discover Your Strengths.

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Below are the top five team members I have selected:

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(Gallup, n.d., 2023).

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Gallup (n.d.). What are the 34 CliftonStrengths Themes? Gallup.com. https://www.gallup.com/cliftonstrengths/en/253715/34-cliftonstrengths-themes.aspx

Hastings, C. (2021, March 30). Hummingbird device for ear tube placement: Interview with Steve Anderson, CEO of Preceptis Medical |. Medgadget. Retrieved February 1, 2023, from https://www.medgadget.com/2021/03/hummingbird-device-for-ear-tube-placement-interview-with-steve-anderson-ceo-of-preceptis-medical.html

Isaacson G. (2020). Tympanostomy Tubes-A Visual Guide for the Young Otolaryngologist. Ear, nose, & throat journal, 99(1_suppl), 8S–14S. https://doi.org/10.1177/0145561320929885

Preceptis Medical (2019). Hummingbird Tts Product Animation. YouTube. Retrieved January 31, 2023, from https://youtu.be/RIFYx2M4xIk.

Spaw, M., & Camacho, M. (2022). Tympanostomy Tube. In StatPearls. StatPearls Publishing. Spaw, M., & Camacho, M. (Update 2022). Tympanostomy Tube. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK565858/

Truitt, T. O., Kosko, J. R., Nimmons, G. L., Raisen, J., Skovlund, S. M., Rimell, F., & Cofer, S. A. (2021). In-office insertion tympanostomy tubes in children using single-pass device. Laryngoscope investigative otolaryngology, 6(2), 325–331. https://doi.org/10.1002/lio2.533