For Parents
FOX Carolina News: Ear Tube Procedure for Children can be Done in 5 Minutes
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.
Brochure: Talking to your Doctor
We want to make it easy to talk to your doctor about the Hummingbird procedure. We’ve developed the following brochure to assist with this conversation and to help educate your provider on the innovative Hummingbird device.
Overview
Each year, nearly one million children will require ear tube placement in the United States alone. A growing number of these families are seeking alternatives to traditional operating room-based approaches. In fact, 93% of these parents have concerns associated with general anesthesia. Now, there is a option for families wishing to avoid general anesthesia and the operating room – the Hummingbird in-office ear tube procedure.
Provider Brochure
View DownloadParent Experience: Lizzie and Jon
Lizzie and Jon’s son, Elliott, experienced frequent ear infections, contracting five infections in just eight months. Ear tube surgery was recommended by their pediatrician, however, the family wanted to avoid general anesthesia for their young son. Learn more about their experience with the Hummingbird.
Parent Experience
View DownloadPreceptis Medical Expands Access to the Hummingbird® Tympanostomy Tube System (TTS) through Medicaid Insurer Pilot Program
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
Brochure: Hummingbird Procedure and Cost Information
Ear tubes are often recommended for children who develop many ear infections in a short period of time. Ear tubes create air flow in the middle ear and allow fluid buildup to drain. They also lessen the chance that a child will get more ear infections.
There are two ways to receive ear tubes: via surgery or in-office placement. While both are safe and effective, it is ultimately the choice of parents to pick the best option for their family and child.
To learn more about ear tube placement options and costs, please click here to download our brochure.
Procedure and Cost Brochure
View Download12News KPNX: Arizona Hospital Testing Innovative Treatment for Ear Infections
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.
Preceptis Medical Receives FDA Clearance for Expanded Labeling for Hummingbird System
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
CBS 5: Phoenix Children’s First in State to Use New Ear Tube Placement Device
PHOENIX (3TV/CBS 5) — Phoenix Children’s Hospital is one of the first hospitals in the nation to use a new device created to make ear tube procedures easier and quicker. The device is called Hummingbird and was created by Preceptis Medical in Minnesota. The Mayo Clinic started using it on young patients who had frequent ear infections which required ear tubes. “When we place typical ear tubes, you make a small cut in the ear drum, clear out any fluid that’s in there and then you place the tube and kind of position it in the drum appropriately. What’s really different about the Hummingbird device, what we really like about it, is that it all happens in one step,” explained Dr. Nate Page. “The device itself allows you to make that cut and leave the tube in the eardrum all at the same time. And that’s really what facilitates using it on these younger kids.”
Dr. Page, who specializes in ear, nose and throat at Phoenix Children’s Hospital, worked with the Mayo Clinic to get the device in Arizona. He says it’s a game changer because the patients do not need anesthesia or any of the other pre-op requirements. “The Hummingbird is done in our clinic, so there’s none of the rigmarole that goes into going in our operating room. They come in just like a regular doctor visit,” explained Dr. Page.
One East Valley mom said her daughter, who is just under 2 years old, needed ear tubes after getting constant ear infections. “She started getting consistent ear infections when she was about 7 months old and pretty much she was on a constant antibiotic for almost a year,” said Krystal Arnett. “After like the fourth or fifth ear infection I was like, we need to do something.”
Arnett and her daughter, Phoebe, met with Dr. Page and learned about the Hummingbird. “He said, ‘Hey we just rolled out this new procedure, we’ve only had a couple kids do it. It allows us to put the tubes in her ears in office and she can be awake,’” Arnett said. “If I don’t have to put her under, that was a huge selling point to me.”
Arnett said they were out of the doctor’s office within 10 minutes. “We put her on the table, we wrap her in a little blanket just so she stays still. There were a couple nurses and I just hold her. They numb each ear and just do the procedure. It literally took like two seconds on each side,” Arnett said. “The whole thing start to finish, when she was on the table, was probably five minutes. It was super quick.”
Dr. Page said Phoenix Children’s has been using the Hummingbird since December, but so far, it’s only been used on about 35 patients. “Our numbers are still relatively small with what we’re doing. But we also started very cautiously doing only very specific kids that we chose to help make progress and then as we’ve seen the success now we’re widening that to be able to offer it to more and more kids,” Dr. Page said.
The COO of Preceptis Medical, Greg Mielke, said they plan to further scale and accelerate access for parents and providers to address strong demand throughout the country for this new option. “We are adding sites frequently and driven to make this an option for all parents!” said Mielke.
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For Youngsters, Getting Ear Tubes No Longer Involves Surgery
Small Children With Recurring Ear Infections Can Receive Ear Tubes During a Quick, In-Office Procedure
Like a lot of young children, from the time she was a year old, Cassidy Clapp was plagued by one ear infection after another.
Usually, an ear infection diagnosis meant Cassidy would undergo a round of antibiotics. But when her Orange County pediatrician noticed the fluid wasn’t draining out of Cassidy’s ear, he recommended inserting tubes into the toddler’s ears.
“I think her hearing was 70% affected, by the fluid buildup” said Cassidy’s mother, Brittany Clapp. ”She always sounded like she was underwater and she didn’t have a lot of speech.”
Brittany and her husband, Charlie, tried as many natural remedies as they could to clear Cassidy’s ears–including acupuncture–but nothing worked. Still, the family was hesitant to have Cassidy undergo surgical anesthesia at such a young age.
“It just seemed like a lot of risk and my mom had bad reactions to anesthesia and I didn’t want Cassidy to go through that,” Brittany said.
After numerous calls and doctor visits, the parents made their way to Gene Liu, MD, at Cedars-Sinai Guerin Children’s. Liu, an ear, nose and throat specialist who is also the president of the Cedars-Sinai Medical Group and the director of Academic Otolaryngology for Cedars-Sinai Medical Center, says fluid that gets trapped in the middle ear can sit there for months.
Gene Liu, MD, holding the Hummingbird device. Photo by Cedars-Sinai.
“It can muffle the hearing and delay speech and language development,” Liu said.
Liu routinely places ear tubes in young children’s ears. Traditionally, the placement is done under anesthesia in an operating room. Surgeons poke a hole in the eardrum, drain all the excess fluid and insert the small plastic tube to lessen the pressure and give the fluid a different pathway out of the ear.
Despite the fact that the actual procedure is quick, surgery is often a full-day ordeal for the young child, with no eating or drinking, an early check-in, post-anesthesia grogginess and, often, nausea.
A New Device
A device called the Hummingbird is a game changer for parents, Liu said. “The entire process, by the time we get the child into the room, into position, clean out the ears and put in the tubes is four to five minutes,” said Liu.
The best part, according to Liu: The child is feeling and hearing better within minutes.
The Hummingbird is shaped like its namesake bird and is a single-pass device, meaning that when the needle enters the ear canal, the tube is automatically inserted.
Although the Hummingbird was approved two years ago, the pandemic prevented many parents from learning about this new option. Cedars-Sinai was one of the initial eight institutions across the country involved in clinical trials of the Hummingbird and now the Food and Drug Administration is looking at expanding the approval to older children as well.
Liu performed a Hummingbird procedure on Cassidy in April.
“They wrapped her up kind of like an extreme swaddle and I was holding her hand and he went in and super-fast one ear was done and then the other and we’re done,” mom Brittany Clapp said. “She cried for about a minute and then was high-fiving Dr. Liu as we left the office.”
The change in Cassidy was immediate. “She heard birds chirping for the first time and was so excited,” Brittany said.
But the best part? When her daughter said, “Mama.”
West Michigan Doctor Using First-of-its-Kind Device For Ear Infections
GRAND RAPIDS, Mich. — A West Michigan doctor hopes a first-of-its-kind device that treats ear infections saves families time, money and stress.
“The goal really is for all of us to see what we can do to reduce operating room cases when we can, let’s see what we can do to do more stuff in the office when it’s safe and appropriate,” said Dr. Joseph Taylor, an ENT at Grand Rapids Ear, Nose, & Throat.
Taylor is the first ENT in West Michigan to use the Preceptis Hummingbird device.
The Hummingbird device allows doctors to put ear tubes in from their office in five minutes. The FDA approved the procedure in 2020. The ideal candidates are children ages 6-to-24 months old.
Traditionally, ear tube procedures occur in an operating room and require general anesthesia. It can cost up to $5,000.
“It’s the exact same process, exact same results, exact same benefits, just not the exact same way to do it,” said Taylor.
Lauren and Matt Van Ryn, who live in Byron Center, say The Hummingbird device brought a sense of normalcy to their family.
In three months, their daughter suffered four ear infections.
“We haven’t had to go to the doctors, we haven’t had to deal with fevers or fussiness,” said Lauren. “She always was spiking a fever, she was on pretty heavy antibiotics every couple of weeks, and she was getting sick from the antibiotics because her stomach just wasn’t tolerating them.”
The couple opted for The Hummingbird device because they wanted to avoid putting their daughter under general anesthesia. It also worked better with their work schedules.
They say if their other daughter has issues with ear infections in the future, they would choose The Hummingbird device in a heartbeat.
“We’re not on pins and needles waiting for the next one,” said Matt. “We feel at ease that she’s healthy.”
