Background: A single practice’s treatment protocol and outcomes following molding therapy on newborn ear deformations and malformations with the EarWell Infant Ear Correction System were reviewed. A classification system for grading the severity of constricted ear malformations was created on the basis of anatomical findings.
Methods: A retrospective chart/photograph review of a consecutive series of infants treated with the EarWell System from 2011 to 2014 was undertaken. The infants were placed in either deformation or malformation groups. Three classes of malformation were identified. Data regarding treatment induction, duration of treatment, and quality of outcome were collected for all study patients.
Results: One hundred seventy-five infant ear malformations and 303 infant ear deformities were treated with the EarWell System. The average age at initiation of treatment was 12 days; the mean duration of treatment was 37 days. An average of six office visits was required. Treated malformations included constricted ears [172 ears (98 percent)] and cryptotia [three ears (2 percent)]. Cup ear (34 ears) was considered a constricted malformation, in contrast to the prominent ear deformity. Constricted ears were assigned to one of three classes, with each subsequent class indicating increasing severity: class I, 77 ears (45 percent); class II, 81 ears (47 percent); and class III, 14 ears (8 percent). Molding therapy with the EarWell System reduced the severity by an average of 1.2 points (p < 0.01). Complications included minor superficial excoriations and abrasions.
Conclusion: The EarWell System was shown to be effective in eliminating or reducing the need for surgery in all but the most severe malformations.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
From Pediatric Plastic Surgery Institute.
Received for publication April 4, 2016; accepted September 1, 2016.
Disclosure: Dr. Byrd has a royalty agreement with Becon Medical for his work designing the EarWell device. Dr. Ha has financial investment in Becon Medical. None of the other authors have any other financial disclosures that might pose or create a conflict of interest with information presented in this article. No funding was received for the work presented in this article.
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H. Steve Byrd, M.D., Pediatric Plastic Surgery Institute, 9101 North Central Expressway, Suite 600, Dallas, Texas 75231, email@example.com