Treatment of Prominent Ears with an Implantable Clip System: A Pilot Study.

Abstract

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. The study aimed to test the safety and behaviour of the implant in vivo. 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. 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. 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.