Study Examines Effects, Complications of Tympanostomy Tube Placement in Children with Cleft Palate

Alyssa KirkmanACPA News, Journal

  • Most children with cleft palate will likely need tympanostomy tubes.
  • The age of first tube placement may affect the total number of tympanostomy procedures.
  • The benefits of tube placement before palatoplasty should be weighed against possible complications, including calcification, perforation, and thickening of the eardrum.

CHAPEL HILL, N.C. / July 16, 2019 – Almost all children with cleft palate will eventually need surgery to insert tympanostomy tubes. A recent study examined the impact of when these tubes are placed with regard to complications and tube replacement. The study, “The Impact of Timing of Tympanostomy Tube Placement on Sequelae in Children With Cleft Palate”, was published in the July 2019 issue of The Cleft Palate-Craniofacial Journal (CPCJ).

Otitis media with effusion—fluid in the middle ear—occurs in more than 80 percent of otherwise healthy children before the age of 2 years. Children with cleft palate (CP) experience nearly universal middle ear effusion, with 91 to 100 percent occurrence, based on previous studies. Although some research indicates that early tympanostomy tube placement in children with CP can optimize hearing, speech, and language, other studies caution that this approach can damage the eardrum, leading to calcification, perforation, or thickening.

“To our knowledge, no previous studies examined how the timing of tympanostomy tube placement might influence the total number of tubes received and the frequency of tube-related complications within a group with routine tube placement at or before palatoplasty,” said lead researcher Amber D. Shaffer, PhD. “In this study we wanted to determine whether children who received their first tympanostomy tubes at palatoplasty went on to undergo more or fewer tube surgeries and tube-related complications than their peers who received tubes earlier—before palate repair.”

Researchers included 147 children born between April 2005 and April 2010 who were seen at the Cleft Craniofacial Clinic at UPMC Children’s Hospital of Pittsburgh. Patients with CP with or without cleft lip were included if they underwent cleft repair and were at least 5 years old at the time of their last clinic visit. Tympanostomy tube history was noted and included the child’s age and middle ear findings when initial tubes were placed; the total number of tube placements, with and without myringotomy; whether the child received tubes after palatoplasty; whether a long-term tube was placed; and the child’s age when the last tube was placed and/or lost.

Of the 147 children included in the study, 65 had isolated CP, 55 had unilateral cleft lip and palate, and 27 had bilateral cleft lip and palate. Tubes were placed in 145 children and the median age of first tube placement was 6.5 months. Most children (119) received tubes before palatoplasty, while 26 received tubes at the time of palatoplasty. The remaining 2 did not need any tube placement. More than one tube surgery was needed in 99 cases, including 85 of the 147 patients with additional tube surgeries after palatoplasty.

Otorrhea (ear drainage) was the most common complication (103 of 145), followed by myringosclerosis (scarring of the eardrum) (51 of 145), granulation (an inflammatory reaction of the eardrum) (33 of 145), and perforation (a hole in the eardrum) (26 of 145). Tube placement before palatoplasty was associated with otorrhea, and children who were younger at the time of their first tube placement often developed otorrhea and bilateral effusion. Additionally, cleft lip and palate and otorrhea were associated with tube placement before palatoplasty, and patients with tubes before palatoplasty, genetic disorders, failed newborn hearing screen, otorrhea, and granulation received a greater number of tubes.

“We found that patients who received tubes before palatoplasty received significantly more tubes overall than those who did not receive tubes before palatoplasty,” Shaffer noted. “Therefore, we recommend that the potential for developing otorrhea and a need for additional tubes should be weighed against the risks associated with prolonged effusion when considering tube placement prior to palatoplasty.”

“The prevalence of middle ear infection is very high in infants one to two years of age. It is even higher in children with cleft palate due to the difficulty in opening the Eustachian tube. Almost 100% of the children with cleft palate in the U S will receive pressure equilibrating tubes,” stated Jack C. Yu, DMD, MD, MS ED, Editor of CPCJ. “This article examines the outcome of such ear tube placement surgery and found that earlier placement, before palate repair, is associated with more ear drainage and higher number of sets of tubes. It is important to keep in mind that the design of the study is retrospective case review and as such the infants receiving tubes early may have more severe diseases. To decrease the incidence of ear infections, the CDC recommends all mothers breastfeed during the first six months after delivery and keep babies’ vaccination up to date.”

To learn more about the American Cleft Palate-Craniofacial Association and cleft and craniofacial conditions, please visit

About the American Cleft Palate-Craniofacial Association
The American Cleft Palate-Craniofacial Association (ACPA) is a nonprofit 501(c)(3) association of interested individuals and health care professionals who treat and/or perform research on oral cleft and craniofacial conditions. Since 1943, ACPA has worked to optimize outcomes for individuals with oral cleft and craniofacial conditions through education, support, research, advocacy and interdisciplinary team care. ACPA also provides information to affected individuals and families and seeks to educate the public about facial differences through its ACPA Family Services program. For more information, please visit