Abstract
BACKGROUND: The earFold™ implantable clip system is a new treatment for prominent ears using an implant made from nickel-titanium alloy, forged into a predetermined shape. The implant is fixed to the cartilage then released, causing the cartilage to fold back. OBJECTIVES: The study aimed to test the safety and behaviour of the implant in vivo. METHODS: This was a Phase 1, prospective, nonrandomised study. Thirty-nine patients were recruited, from 7 to 57 years of age (22 adults and 17 children). Thirty-seven patients were followed up for a minimum of 18 months. A total of 131 implants was used to treat 75 ears. All treatments were performed under local anaesthetic. RESULTS: Eighteen patients asked for their implants to be left in place permanently. Twenty-one patients agreed to have their implants removed at 6, 12, or 18 months after insertion. Complications affected 8 patients and included extrusion, infection, hypertrophic scarring, and Spock-ear formation. No new complications have arisen in any of the patients since the conclusion of the study, up to a maximum of 47 months. Patients were overwhelmingly satisfied with the outcome of treatment. CONCLUSIONS: earFold can be used as a permanent implant to correct prominence of the human ear. It is best suited for treating prominent ears with a poorly formed or absent antihelical fold. The procedure is quick and predictable with a complication rate comparable to suture-based otoplasty techniques.