An implantable clip system may be used as permanent implant to correct prominent ears, according to study results.
The earFold implant, a permanent metal implant for minimally-invasive correction of prominent ears, has received CE mark approval for use in the United Kingdom but is not approved in the United States.
Researchers in the United Kingdom conducted a prospective, nonrandomized study between July 2011 and September 2013 of 39 patients (22 females; average age, 24 years), including 22 adults aged 16 years and older and 17 children aged 7 to 15 years. Patients had a helical-mastoid distance (H-M distance) of greater than 20 mm.
There was a final follow-up assessment for 37 patients at 18 months, with some patients continuing follow-up beyond that point. There were 131 earFold implants to treat 75 ears.
Insertion and removal of the implant was done under location anesthetic. It took approximately 3 minutes to insert each implant and an average of 1.7 minutes to remove each implant.
There were 21 patients who agreed to have their implants removed at 6, 12 or 18 months after insertion, while 18 patients requested that the implants be permanently left in place.
The was a 29.67 mm average H-M distance per ear, with a 37% reduction in prominence per ear at 3 months after treatment. Patients who had their implants left in place had a 33.5% reduction in H-M distance after 3 months and 34.6% reduction after 18 months.
Among patients who had the earFold removed after 6, 12 or 18 months after insertion, adults with earFold treatment alone experienced a 3.4% reduction in H-M distance after 12 months and a 12.6% reduction after 18 months in place. Children experienced a 10% in H-M distance after 12 months and 13.7% reduction after 18 months in place with the earFold treatment alone.
Survey results showed a statistically significant improvement in patient satisfaction between baseline and final assessments.
Eight patients reported adverse events, including extrusion, infection, hypertrophic scarring and Spock-ear formation at up to 12 months after insertion.
“This pilot study confirmed that earFold can be used to achieve this objective as part of a local anesthetic procedure which is rapid, simple to perform, and simple to master,” the researchers wrote. “Importantly, using preFold positioners for preoperative assessment allows treatment with earFold to have more predictable outcome compared with standard ostoplasty.”
“As for all surgical techniques, earFold has its own risks and drawbacks,” the researchers concluded. “Moreover, it cannot be used to treat every case of prominent ear.” – by Bruce Thiel
Disclosure: The researchers report no relevant financial disclosures.