FDA Approves Device For Ear Tube Surgery Without Anesthesia

Pediatrician using otoscope

Pediatrician using otoscope to examine baby's ear

Getty

Ear infections and ear pain are the most common reason that a child goes to see a doctor. The vast majority of all children will have at least one or more ear infections by their third birthday. Ear infection symptoms can include severe ear pain, as well as cold-like symptoms including cough, runny nose, fever, headache, and irritability. And as with most medical issues in children, symptoms are always worse late at night, making for irritable, sleep-deprived parents along with their irritable, sleep-deprived children. While most ear infections are caused by viruses similar to cold viruses, overuse of antibiotics for ear infections has contributed substantially to the current state of affairs when it comes to antibiotic resistance. While published guidelines were created to better delineate which children are best served with antibiotics and which are better served with pain control (ibuprofen in children over age 6 months and acetaminophen in all infants and children), there has been little headway in reduction of antibiotic overuse in this patient population.

An ear infection is defined as infected fluid behind the ear drum. The ear drum itself is a piece of thin skin protecting the middle ear, which is in connection with the back of the nose via the eustachian tube. When fluid/viruses/bacteria from the back of the nose get trapped in the middle ear space, the ear drum, which contains many nerve fibers, bulges, causing pain.

With ear infections being the most common reason for a child to visit a doctor, ear tube surgery is the most common surgery performed in children. The annual cost of ear infection care, not including costs of ear tube surgery, is over $3 billion. The number of children undergoing ear tube surgery ranges from 500,000 to 1,000,000 annually in the United States alone. Ear tubes (also known as pressure equalization tubes) act as tiny ‘mature drainage systems’ to prevent fluid accumulation, infections, and hearing loss in young children with recalcitrant ear infections and/or chronic fluid leading to hearing loss and speech delay. Just as antibiotic overuse has come in to question in the treatment of ear infections, the question of ear tube overuse has been raised and studied, with indications and guidelines for surgery now routinely assessed and updated.

Check out this video of a young child undergoing ear tube surgery. While every surgery is different, in general, it’s a five to ten minute procedure (sometimes as short as one or two minutes) under general anesthesia. Usually no intravenous line is needed, nor is an endotracheal (breathing) tube placed. Most kids go home 30-60 minutes after the procedure, and they resume their usual activities the next day. Relief of symptoms is usually immediate.

Despite this being a short surgery with excellent outcomes, folks have raised concerns about needing general anesthesia, even for such a brief period of time. But keep in mind a few things: most kids who need ear tubes are between ages one and three years, a microscope is used to obtain best visualization, a precise, tiny incision is made in the ear drum and the fluid is suctioned, and a tube just over one millimeter in size is inserted carefully in the ear drum. While it seems simple, otolaryngologists train years to do this quickly and correctly.

A new system was recently approved by the FDA which will enable ear tubes to be performed in the office under local anesthesia, avoiding potential risks of general anesthesia, a second visit for surgery, and will likely lower costs as well. The system, known as Tula (Tubes under local anesthesia) utilizes a small electrical current to administer local anesthesia to the ear drum. A second device provides an automated insertion of an ear tube into the ear drum. The company that designed the system, Tusker Medical, sponsored a study of 222 pediatric patients, and reported up to 89% successful tube insertions. Dr. Douglas Sidell, Assistant Professor in the Division of Pediatric Otolaryngology at Stanford, has some concerns about any new technology, especially one that is being compared to a “a procedure in the OR that requires 1-2 minutes of inhalational anesthesic and is performed in a safe and comfortable fashion.” He further voices the issue of whether improving something that is already the “gold standard” and is safe and effective is really beneficial. “I always consider the physical and emotional consequences of each environment on the child, the potential for adverse effects...and the ability to perform the procedure effectively.”

In principle, tube surgery in the office sounds like a great idea: avoiding general anesthesia, minimizing delay in intervention, with painless surgery in the doctor’s office. While FDA vetting recently brought this technology to many press outlets, the concept of in-office ear tube placement is not new. In the late 1990’s, office-based laser-assisted myringotomy (known as OtoLAM) met with some success in some institutions. In this procedure, topical anesthetic drops were place onto the ear drum for numbing, followed by making the ear drum incision with a laser, followed by placing a tube.

Many surgeons, however, found the mechanics of laser-assisted myringotomy to be cumbersome, and the need to restrain young patients to get a perfect view of their tiny ear drum prior to making a precise hole and inserting a tiny tube was potentially more traumatic, and even riskier to the ear drum, than five minutes of monitored anesthesia with a perfectly magnified view of the ear under a microscope. Dr. Michael Cunningham, Professor at Harvard Medical School and Otolaryngologist-in-Chief at Boston Children’s Hospital, had experience trying OtoLAM, and raises similar concerns for the new technology: “Such devices are most useful in patients with large ear canals. In younger children with small ear canals, one is placing a tube with quite limited visual access of the actual placement site.” He also points out that if there is any discomfort in performing the procedure on the first side, “the child is not going to let you perform the procedure on the [second ear].”

While new technology is important to explore, especially for such a commonly performed procedure, we must all keep in mind that technology is no substitute for technique. In addition, perhaps innovation should focus more on prevention and less on intervention. According to Dr. Sidell, “Although ear tube placement remains one of the most common procedures in children worldwide, the development of a device or strategy to reduce the incidence of middle ear disease (ear infections and ear fluid) before ear tubes are required would be one step in a better direction.”

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Ear infections and ear pain are the most common reason that a child goes to see a doctor. The vast majority of all children will have at least one or more ear infections by their third birthday. Ear infection symptoms can include severe ear pain, as well as cold-like symptoms including cough, runny nose, fever, headache, and irritability. And as with most medical issues in children, symptoms are always worse late at night, making for irritable, sleep-deprived parents along with their irritable, sleep-deprived children. While most ear infections are caused by viruses similar to cold viruses, overuse of antibiotics for ear infections has contributed substantially to the current state of affairs when it comes to antibiotic resistance. While published guidelines were created to better delineate which children are best served with antibiotics and which are better served with pain control (ibuprofen in children over age 6 months and acetaminophen in all infants and children), there has been little headway in reduction of antibiotic overuse in this patient population.

An ear infection is defined as infected fluid behind the ear drum. The ear drum itself is a piece of thin skin protecting the middle ear, which is in connection with the back of the nose via the eustachian tube. When fluid/viruses/bacteria from the back of the nose get trapped in the middle ear space, the ear drum, which contains many nerve fibers, bulges, causing pain.

With ear infections being the most common reason for a child to visit a doctor, ear tube surgery is the most common surgery performed in children. The annual cost of ear infection care, not including costs of ear tube surgery, is over $3 billion. The number of children undergoing ear tube surgery ranges from 500,000 to 1,000,000 annually in the United States alone. Ear tubes (also known as pressure equalization tubes) act as tiny ‘mature drainage systems’ to prevent fluid accumulation, infections, and hearing loss in young children with recalcitrant ear infections and/or chronic fluid leading to hearing loss and speech delay. Just as antibiotic overuse has come in to question in the treatment of ear infections, the question of ear tube overuse has been raised and studied, with indications and guidelines for surgery now routinely assessed and updated.

Check out this video of a young child undergoing ear tube surgery. While every surgery is different, in general, it’s a five to ten minute procedure (sometimes as short as one or two minutes) under general anesthesia. Usually no intravenous line is needed, nor is an endotracheal (breathing) tube placed. Most kids go home 30-60 minutes after the procedure, and they resume their usual activities the next day. Relief of symptoms is usually immediate.

Despite this being a short surgery with excellent outcomes, folks have raised concerns about needing general anesthesia, even for such a brief period of time. But keep in mind a few things: most kids who need ear tubes are between ages one and three years, a microscope is used to obtain best visualization, a precise, tiny incision is made in the ear drum and the fluid is suctioned, and a tube just over one millimeter in size is inserted carefully in the ear drum. While it seems simple, otolaryngologists train years to do this quickly and correctly.

A new system was recently approved by the FDA which will enable ear tubes to be performed in the office under local anesthesia, avoiding potential risks of general anesthesia, a second visit for surgery, and will likely lower costs as well. The system, known as Tula (Tubes under local anesthesia) utilizes a small electrical current to administer local anesthesia to the ear drum. A second device provides an automated insertion of an ear tube into the ear drum. The company that designed the system, Tusker Medical, sponsored a study of 222 pediatric patients, and reported up to 89% successful tube insertions. Dr. Douglas Sidell, Assistant Professor in the Division of Pediatric Otolaryngology at Stanford, has some concerns about any new technology, especially one that is being compared to a “a procedure in the OR that requires 1-2 minutes of inhalational anesthesic and is performed in a safe and comfortable fashion.” He further voices the issue of whether improving something that is already the “gold standard” and is safe and effective is really beneficial. “I always consider the physical and emotional consequences of each environment on the child, the potential for adverse effects...and the ability to perform the procedure effectively.”

In principle, tube surgery in the office sounds like a great idea: avoiding general anesthesia, minimizing delay in intervention, with painless surgery in the doctor’s office. While FDA vetting recently brought this technology to many press outlets, the concept of in-office ear tube placement is not new. In the late 1990’s, office-based laser-assisted myringotomy (known as OtoLAM) met with some success in some institutions. In this procedure, topical anesthetic drops were place onto the ear drum for numbing, followed by making the ear drum incision with a laser, followed by placing a tube.

Many surgeons, however, found the mechanics of laser-assisted myringotomy to be cumbersome, and the need to restrain young patients to get a perfect view of their tiny ear drum prior to making a precise hole and inserting a tiny tube was potentially more traumatic, and even riskier to the ear drum, than five minutes of monitored anesthesia with a perfectly magnified view of the ear under a microscope. Dr. Michael Cunningham, Professor at Harvard Medical School and Otolaryngologist-in-Chief at Boston Children’s Hospital, had experience trying OtoLAM, and raises similar concerns for the new technology: “Such devices are most useful in patients with large ear canals. In younger children with small ear canals, one is placing a tube with quite limited visual access of the actual placement site.” He also points out that if there is any discomfort in performing the procedure on the first side, “the child is not going to let you perform the procedure on the [second ear].”

While new technology is important to explore, especially for such a commonly performed procedure, we must all keep in mind that technology is no substitute for technique. In addition, perhaps innovation should focus more on prevention and less on intervention. According to Dr. Sidell, “Although ear tube placement remains one of the most common procedures in children worldwide, the development of a device or strategy to reduce the incidence of middle ear disease (ear infections and ear fluid) before ear tubes are required would be one step in a better direction.”

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