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Postoperative restenosis in patients with external ear canal (EEC) atresia or stenosis is a common complication following canaloplasty. Our aim in this study was to explore the feasibility of using a three dimensionally (3D)-printed, patient-individualized, drug ((dexamethasone (DEX)), and ciprofloxacin (cipro))-releasing external ear canal implant (EECI) as a postoperative stent after canaloplasty. We designed and pre-clinically tested this novel implant for drug release (by high-performance liquid chromatography), biocompatibility (by the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay), bio-efficacy (by the TNF-α (tumor necrosis factor-alpha)-reduction test (DEX) and inhibition zone test (for cipro)), and microbial contamination (formation of turbidity or sediments in culture medium). The EECI was implanted for the first time to one patient with a history of congenital EEC atresia and state after three canaloplasties due to EEC restenosis. The preclinical tests revealed no cytotoxic effect of the used materials; an antibacterial effect was verified against the bacteria Staphylococcus aureus and Pseudomonas aeruginosa, and the tested UV-irradiated EECI showed no microbiological contamination. Based on the test results, the combination of silicone with 1% DEX and 0.3% cipro was chosen to treat the patient. The EECI was implantable into the EEC; the postoperative follow-up visits revealed no otogenic symptoms or infections and the EECI was explanted three months postoperatively. Even at 12 months postoperatively, the EEC showed good epithelialization and patency. Here, we report the first ever clinical application of an individualized, drug-releasing, mechanically flexible implant and suggest that our novel EECI represents a safe and effective method for postoperatively stenting the reconstructed EEC. [ABSTRACT FROM AUTHOR]

Objectives/Hypothesis: This study was undertaken to assess a transcanal osteotome technique for removing symptomatic ear canal exostoses. Outcome measures included healing rates and the rate of complications. Study Design: Prospective study in a private practice. Methods: A straight 1-mm osteotome and a curved 1-mm osteotome were used by way of a transcanal approach to incrementally remove obstructive ear canal exostoses. If anterior or superior bone growths were closely approximating the tympanic membrane, they were partially removed with a 1.5 mm cylindrical end- and side-cutting burr. Healing rates were monitored with weekly postoperative visits. Results: Two hundred twenty-one ear canals (140 patients) were consecutively treated with this technique. Healing was achieved at 2 to 8 (average 3.50) weeks, with 90% healed by 4 weeks. There were 4 mobilizations of a full-thickness segment of anterior bony canal wall; 3 exposures of periosteum anterior to the anterior bony wall; 1 tear of the tympanic membrane requiring a tympanoplasty; 18 anterior and 11 posterior tympanic membrane tears that healed spontaneously; 3 instances of sensorineural hearing decrease; 3 cases of new-onset postoperative tinnitus; and 1 instance of postoperative positioning vertigo. There were no lacerations of the tympanic membrane by an osteotome, no facial nerve injuries, no soft tissue stenoses of an ear canal, and no skin grafting of an ear canal. Conclusions: The described technique of using osteotomes transcanal for removal of symptomatic obstructive ear canal exostoses promoted rapid healing and was effective and safe. [ABSTRACT FROM AUTHOR]