Aurora, CO (CBS Colorado) – Thousands of kids in Colorado get ear tubes every year. It’s one of the most common pediatric procedures, even though it can get expensive and requires general anesthesia.

But, that’s now changing at Children’s Hospital Colorado.

Like many toddlers, 18-month-old Bryson has had a few ear infections.

“Before he turned one, he had his first ear infection,” said his mother, Taylor Pinkus. “We really didn’t think much of it because he got over it really quickly. Then we started daycare in February of this year, and that was when they were just nonstop.”

That meant it was time for little Bryson to get ear tubes. Typically, ear tube procedures happen in an operating room with the child under anesthesia. However, just before Bryson’s scheduled surgery in early June, his mom learned of a new device that wouldn’t require her son to go under.

“And I was able to be right next to him, which was the best part because going into the operating room, parents don’t get to go back there,” Pinkus told CBS Colorado’s Kelly Werthmann.

Dr. Gregory Allen at Children’s Hospital Colorado did Bryson’s ear tube procedure using the FDA-approved device called The Hummingbird.

“In kids, their eustachian tube doesn’t work well, so they cannot pop their ears and equalize the pressure as easily as we can as adults,” he explained. “To put tubes in the ears, it’s necessary to make a small hole or small incision in the eardrum. After that incision is made, a tube is inserted into that incision. [The Hummingbird] allows us to make the hole in the ear drum and to place the tube all at one time.”

It’s almost like a piercing gun, he said. Using localized anesthesia on the ear drum, The Hummingbird device allows doctors to quickly place the tube in both ears in just a matter of minutes.

“Because it’s very quick and the device makes it very safe to do in young children,” said Allen, “We can do it in the office with minimal discomfort… and it’s more cost-efficient because we avoid operating room time and general anesthesia.”

Pinkus said her little boy was calm and comfortable during his procedure.

“Honestly, he did great,” she said. “They had a little papoose wrap on the table; it was just Velcroed around him. The entire procedure lasted
maybe three to four minutes, and as soon as he was unwrapped and in my arms, he was fine.”

Since Bryson got his ear tubes earlier this summer, Pinkus said her son has been ear infection-free.

“It was a great experience,” she said.

Bryson is among the first patients to receive ear tubes with The Hummingbird at Children’s Hospital. Allen said he’s treated only a half dozen children or so with the new device over the last several months, but he expects it to become more widely used soon.

While Allen said 18 months of age or younger is ideal for using The Hummingbird, the device has been approved for ages 6 months through adult. It is best to consult with your child’s pediatrician or your physician.

All parents know that when it comes to kids’ favorite summer activities, swimming is often at the top of the list. We understand that some parents may have concerns and questions regarding swimming after ear tube placement.

If your question is, “Can my child swim with ear tubes?” The answer is yes.

To answer this question more thoroughly and provide helpful insight, we’ve developed a guide with tips and resources to help parents better understand how to safely swim with ear tubes.

Understanding Ear Tubes

Ear infections in children are the most common reason families visit their pediatrician’s office each year in the United States. Studies show that 75% of pediatric patients will have at least one ear infection by the time they are 3 years old, and 1 in 15 children will have ear tubes placed.¹

Ear tubes, also known as tympanostomy tubes, are very small, hollow tubes that are placed in the eardrums. They are often recommended for children who develop repeat ear infections in a short period of time. Ear tubes help drain fluid from the middle ear and equalize pressure, helping reduce the risk of future ear infections and improving hearing that is decreased due to fluid in the middle ear.

How Are Ear Tubes Placed?

Most commonly, ear tube placement is performed in an operating room setting, which involves fasting, pre-operative requirements and general anesthesia. The process may take up to a full day with post-recovery care and at-home monitoring.

There is also an alternative to ear tube surgery, called the “Hummingbird procedure.” Ear tube placement with the Hummingbird is performed in an ENT’s office without general anesthesia. Children undergoing the Hummingbird procedure receive a topical numbing medicine, allowing them to be awake during the process. Completed in minutes, recovery time is typically not required and children may return to normal activities immediately following treatment.²

Swimming With Ear Tubes: Important Questions and Their Answers

Regardless of how ear tubes are placed, swimming with ear tubes is generally considered safe. However, it is recommended that parents take precautions to avoid infections of the ear when enjoying the water.

Below are some helpful guidelines and tips for families.

How Soon Can You Swim After Getting Ear Tubes?

With any medical procedure, there should be a period of downtime for sufficient recovery; this is no different after ear tube placement. Typically, the surgeon will recommend at least a day of recovery before your child can swim with tubes in their ears.³

Can You Swim Underwater With Ear Tubes?

When the head is submerged underwater, there is a possibility that water may make its way to the eardrum. If the eardrum contaminated, this fluid can cause an infection leading to pain and ear drainage. The longer the head is submerged, or the deeper the swimmer goes (e.g. diving), the higher the likelihood that water will enter the eardrum.

While ear tubes are in place, children do not always need to wear ear plugs for swimming and bathing. However, recommended ear protection can be particularly helpful in the following situations:

• For older children who may be more active in the water, especially when submerging the head
• For children who experience pain or discomfort when water enters the ear canal
• For children that swim in lakes or non-chlorinated pools that may have high bacteria concentrations

There are several types of soft ear plugs or ear putty available, as well as neoprene headbands to cover the ears. Never use Play-Doh or Silly Putty as an ear plug — these materials can become trapped in the ear canal and even require surgical removal.⁴

What About Swimming After Ear Tubes Fall Out?

When ear tubes fall out, water precautions are often unnecessary as the opening in the eardrum is no longer present. However, a medical provider should assess the ear to ensure that the perforations have completely healed. If there is still an opening where the tube used to be, parents should continue to take precautions while children are swimming.

Swimming With Ear Tubes: Final Thoughts

Remember to consult with your surgeon, ENT or healthcare provider for personalized advice and guidance on swimming with ear tubes or other ear-related concerns.

Keeping these tips in mind, swimming with ear tubes doesn’t need to change your child’s ability to enjoy the water.

Contributors
Thank you to our contributing author, Dr. Theodore O. Truitt of St. Cloud Ear, Nose & Throat.

References
1) National Institutes of Health; Ear Infections in Children; 2022.
2) Overall procedure times vary.
3) The Center for Minimally Invasive Surgery; When Can I Swim After Ear Tube Placement or Removal; 2022.
4) American Academy of Otolaryngology-Head and Neck Surgery (AAO-HSN); Clinical Practice Guidelines: Patient information for Ear Tubes – A Caregiver’s Guide. 2022.
5) Children’s Health; How to Get Rid of Swimmer’s Ear. Tips for Preventing and Treating this Painful Ear Infection; 2023.

MARCH 5, 2024—MINNEAPOLIS—Preceptis Medical, an innovative medical technology company dedicated to providing less invasive ear tube options for children, announced today the launch of its new website for the Hummingbird® Tympanostomy Tube System (TTS).

The introduction of this online resource reflects the company’s growth and increased parental and physician demand for the Hummingbird in-office ear tube procedure. The FDA-cleared device eliminates the need for general anesthesia and the operating room, and only requires a topical numbing anesthetic.

“Preceptis Medical’s new website demonstrates our continued commitment to changing the lives of parents and pediatric patients through decreasing costs and eliminating risks associated with traditional ear tube surgery,” commented Steve Anderson, CEO and Co-Founder of Preceptis Medical. “We are confident this digital resource will deliver helpful decision-making tools for parents, while balancing the needs of ENT surgeons and pediatricians in their research for a safe, simple and less expensive ear tube placement option.”

The website, created with end user experience in mind, includes functionality to help visitors quickly locate required information and resources. Features include an easy-to-use provider locator, documents to help facilitate family / physician discussions regarding the procedure and physician-focused resources.

The Hummingbird, which continues to play a key role in alleviating operating room scheduling constraints and delays in pediatric care, enables ear tubes to be placed in minutes.¹ Parents can be present during the procedure, and children may return to normal activities immediately following treatment.

About Preceptis Medical
Founded in 2011, Preceptis Medical is an innovative medical technology company dedicated to providing less invasive ear tube procedure options for pediatric patients. The FDA-cleared Hummingbird® Tympanostomy Tube System (TTS) streamlines ear tube placement and addresses risks associated with pediatric general anesthesia use. The Hummingbird, indicated for use in patients 6 months of age and older, provides a simple and efficient option for ENTs and parents while reducing healthcare costs. Web: https://www.hummingbirdeartubes.com/

References
¹Procedure times vary.

Media Contact
Leah Davidson, Sr. Director of Marketing
Preceptis Medical
763.568.7810
leah@preceptismedical.com

NEWBERRY, S.C. (FOX Carolina) – Ear infections in children can be painful, and are very common. If a child gets too many in a short period, ear tubes are often the answer. Usually, the procedure is done in a hospital setting with anesthesia, but a new medical device is changing the game.

“We had one big cluster of ear infections that may have been the same one, or may have been multiple ones, but for a month or two, he just has had constant ear infections,” father Stephen Flower said.

Flowers says his one-year-old son, Banks, was constantly fussy due to his ear infections.

“We were really frustrated because we tried all the different antibiotics and the antibiotics upset his stomach,” Flower said.

Newberry ear, nose and throat Dr. Wayne Harsha at Carolina Pines ENT says kids often get ear infections because their eustachian tubes, which connect to your eardrum, are smaller than adults.

“So it doesn’t work as well,” Dr. Harsha said. “A vacuum will form in that space and it will suck bacteria from the nose and cause an ear infection.”

When a child gets three or more ear infections in a six-month period, ear tubes are often recommended.

“We put a hole in the eardrum to equalize the pressure there and it reduces the number of ear infections a kid will get,” Dr. Harsha said.

This usually requires a hospital visit with anesthesia, but a new medical device called the Hummingbird can be done in the office.

“It takes about a minute per side and there is no anesthesia,” Dr. Harsha said.

The handheld device is used to insert the ear tube into the eardrum.

“Our child handled it really well,” Flowers said. “He cried a little bit. But it wasn’t wasn’t bad. It didn’t hurt.”

It doesn’t cure ear infections, but makes it much more comfortable if the child gets one. Flowers says his son has been much better since his procedure in December.

“Before when he got your infections that fluid was trapped behind the eardrum, and it would get really bad,” Flower said. “He pulled from his ears. And he was just fussy all the time.”

Flowers said when his son got an ear infection after the procedure it was much better. The fluid drained and his ear didn’t bother him much.

Right now this procedure is mostly geared for children. It’s not always covered by insurance, but in the case of this family, Flowers said it was cheaper to pay out of pocket than with insurance at the hospital.

MINNEAPOLIS, Minn. – (BUSINESS WIRE) – Preceptis Medical, Inc., an innovative surgical technology company dedicated to providing less invasive ear tube procedure options for pediatric patients, announced today that children will have expanded access to the Hummingbird in-office ear tube procedure through a collaboration with one of the largest Medicaid payers in the United States.

This expanded coverage will help meet increased demand for ear tubes by alleviating operating room (OR) schedules and reducing delays in care for pediatric patients, resultant from the COVID-19 Pandemic. With one million children undergoing OR-based ear tube procedures annually¹, the pilot program shows promise to increase care access and address current health equity challenges encountered by Medicaid populations.

Pilot program participant, Dr. Paula Harmon, MD, MBA, FAAP of Pediatric Ear, Nose & Throat of Atlanta (PENTA) commented, “The Hummingbird device has allowed our practice the opportunity to address rising challenges facing pediatric patients due to OR scheduling constraints and healthcare access inequities.” Voted as a Top ENT Doctor in a national listing of Top Doctors in 2022, Harmon continued, “Our partnership with Preceptis Medical (makers of the Hummingbird TTS) and the Medicaid pilot program will help in our endeavor to remove healthcare disparities, a goal of PENTA since its inception.”

The FDA-cleared Hummingbird device uniquely combines the separate tools and steps performed in surgical ear tube procedures into a comprehensive, single-step process. Utilizing Preceptis Medical’s patented One-Pass® technology, ENT surgeons make an incision and deliver, position and place ear tubes with a single pass device in the office setting.

Available for use in children 6 months of age or older, the Hummingbird eliminates the need for general anesthesia and the OR, as the procedure only requires a topical numbing anesthetic. The Hummingbird, delivering a 98% success rate in clinical studies,² allows parents to be present during treatment and children to return to normal activities immediately following the procedure.

“We are thrilled to collaborate with one of the most respected, well-known managed care payers in the United States on this important initiative. This new partnership is critical as parental and provider demand rises for ear tube placement alternatives that do not involve general anesthesia,” stated Greg Mielke, Preceptis Medical’s Chief Commercial Officer. “The pilot program serves as a critical step in not only increasing healthcare access, but also in expanding coverage and commercial growth initiatives,” Mielke concluded.

To locate a Hummingbird provider, or to learn more about Preceptis Medical’s innovative technology, please visit. www.hummingbirdeartubes.com.

About Preceptis Medical

Founded in 2011, Preceptis Medical is an innovative medical technology company dedicated to providing less invasive ear tube procedure options for pediatric patients. The FDA-cleared Hummingbird® Tympanostomy Tube System (TTS) streamlines ear tube placement and addresses risks associated with pediatric general anesthesia use. The Hummingbird, safe for use in patients 6 months of age and older, provides a simple and efficient option for ENTs and parents while reducing healthcare costs.
Web: https://www.hummingbirdeartubes.com/

References

¹ IBM Marketscan® Commercial Claims and Medicaid Database.

² Truitt, TO, Kosko, JR, Nimmons, GL, et al. In‐office insertion tympanostomy tubes in children using single‐pass device. Laryngoscope Investigative Otolaryngology. 2021;1-7.

Media Contact

Leah Davidson, Sr. Director of Marketing
Preceptis Medical
763.568.7810
leah@preceptismedical.com

12NEWS KPNX-PHOENIX

Thanks to new technology at Phoenix Children’s Hospital (PCH), Dr. Nathan page says ear tube procedures can be accomplished without a trip to the OR.

“The Hummingbird system is designed to facilitate putting in tubes on younger kids in the office. PCH is the first hospital in the state to use the Hummingbird to do ear tube procedures.

The tube is contained in the device, so you push it through a portion of the eardrum and essentially withdraw the device and leave the tube in place, making the process a lot simpler, yet still just as effective,” says Dr. Page.

MAPLE GROVE, Minn.–(BUSINESS WIRE)—Preceptis Medical, Inc., an innovative medical technology company dedicated to providing less invasive options for pediatric patients, today announced U.S. FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children 6-24 months, this new labeling allows in-office procedures in all children six months and older.

The Hummingbird TTS uniquely combines the separate tools and steps performed in standard ear tube procedures into one comprehensive device. With the Hummingbird, otolaryngologists or ear, nose and throat specialists (ENTs) can now make an incision and deliver an ear tube using a single pass in the office environment. The device eliminates the need for fasting, general anesthesia, and an operating room – all with 98% success in the office setting.¹ The procedure requires only a topical anesthetic, and parents can be present with their child to provide further comfort.

“This device has been a gamechanger for patients and families. Having their child’s ear tubes placed in a quick office visit is comforting to parents, and they have been happy with the results. We look forward to offering this procedure to even more eligible patients,” said Dr. Nathan Page, pediatric otolaryngologist at Phoenix Children’s, one of the nation’s largest pediatric health care systems.

“When I first began working with the Preceptis team on the clinical study, my hope was that one day the Hummingbird would be available for all of my pediatric patients,” said Dr. Shelagh Cofer, Division Chair of Pediatric Otolaryngology at the Mayo Clinic. “I am proud to have been a part of the study and excited to see the culmination of years of work in this fully expanded label.”

Approximately one million children undergo ear tube procedures annually in an operating room in the United States alone.² In-office ear tube placement using the Hummingbird can save thousands of dollars per patient by shifting the procedure from the operating room to the office setting.

“Our goal when we started Preceptis was to provide a safe, simple, and less expensive ear tube procedure option to all families. This final label expansion represents the work of many ENTs, clinical study coordinators, and team members, and I appreciate the trust parents put into Preceptis and our ENTs while participating in the study,” said Steve Anderson, Chief Executive Officer, Preceptis Medical.

“Parent and ENT feedback has been extremely positive, and we have seen ever increasing demand for the in-office ear tube procedure option as more parents, pediatricians, and ENTs become aware of the product,” shared Greg Mielke, Chief Commercial Officer for Preceptis. “We have also received strong support from the insurance community both locally and nationally, and this expanded label will increase patient access and improved health equity in our communities.”

Preceptis Medical has successfully completed its initial launch and plans to build on strong momentum and demand from parents and providers through a larger commercial launch to expand access to this option in the future.

About Preceptis Medical

Preceptis Medical was founded by parents, including a pediatric anesthesiologist, who wanted to design products focused on improving the lives of children. The Hummingbird device was developed 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. The Hummingbird® Tympanostomy Tube System (TTS) is FDA 510(k) cleared for use in children 6 months and older. For more information, visit www.hummingbirdeartubes.com.

¹ FDA 510(k) files K200952 and K221254
² IBM Marketscan® Commercial Claims and Medicaid Database.

Contacts

Greg Mielke
Preceptis Medical
763.568.7810
Greg@preceptismedical.com