Otoplasty or EarFold: what the implant is, what the evidence says and why we do not offer it

earFold is an implant placed under the skin of the ear to fold the cartilage, with no internal sutures and under local anaesthetic, in a procedure of about twenty minutes. On paper it sounds like a quick version of an otoplasty.

We do not offer it, and the reason is not that it is dangerous: it is what the published series describe when you read them in full and look at who signed them. This page sets out what there is, with the figures, so that you can decide for yourself.

How a prominent ear is corrected surgically is covered in the otoplasty guide.

What it is exactly

It is a curved strip of metal alloy, a few millimetres long, inserted through a very small incision and deployed over the cartilage of the antihelix. As it springs back to its shape, it folds the ear and brings it closer to the head. It is placed under local anaesthetic and the procedure is short.

It has one advantage from the outset that deserves acknowledging: it lets you preview the result before implanting anything, by marking the position on the ear. That is more than conventional surgery offers, where the result is explained but not shown.

And it has a feature that is sometimes mentioned only in passing: the implant stays inside. It is not a procedure that is done and gone; it is a permanent foreign body under skin that on the ear is particularly thin.

What it corrects, and what it does not

Here is the first limitation, and it is anatomical before it is statistical.

An ear stands out for three reasons: an antihelix that did not fold, a concha that is too deep and an angle greater than usual. They are explained in why prominent ears happen.

The implant acts on the first. It folds the antihelix, and that is all it does. It does not reduce a concha, does not reposition it, does not remove surplus skin and does not correct a lobe that stands away.

That means that, even before looking at any complication, there are ears for which the implant is simply not an option. Not a lesser option: one that does not solve what needs solving.

What the published series say

This is the part that is rarely told in full, so here it is with the figures and with who signed them.

The pilot study (2016), 39 patients. A total of 131 implants were placed in 75 ears, in adults and children, with a minimum follow-up of 18 months. There were complications in 8 patients: implant extrusion, infection, hypertrophic scarring and a pointed deformity. And the figure that weighs most: 21 of the 39 patients requested removal of the implant at 6, 12 or 18 months. Only 18 kept them. The authors concluded that the results were comparable to suture techniques.

The large series (2018), 403 patients and 1,200 implants. It is the reference safety study for the device. It describes adverse effects requiring intervention in 9.7% of patients: implant revision in 4.2%, mostly for visibility; skin erosion in 3.7%; infection in 1.7%. There was no bleeding, haematoma or adverse scarring. The authors attribute the complications to patient selection or to technical errors.

Two qualifications belong alongside those figures. The first is follow-up: of the 403 patients, only 145 — 36% — came back for review, at a mean of 7.7 months. For a permanent implant, that is not much time and not many people. The second is authorship: both the pilot and the large series come from the group linked to the development and promotion of the technique.

An independent series (2025), 19 patients. Long-term follow-up by two surgeons outside that group. Six patients had to have the implant removed because of complications and a seventh asked for removal. The authors concluded by discontinuing its use.

What emerges when you put them side by side is not that the technique is dangerous. It is that the most favourable figures come from those who developed it, that the published follow-up is short, and that when others have followed it up over the long term the results have been worse. That asymmetry is worth knowing before deciding.

How it compares with conventional otoplasty

Surgery has a body of evidence on another scale altogether. Recent meta-analyses describe a combined recurrence rate of 2.8% and reoperation of 2.1%, with mean follow-up of more than two years, and the largest systematic review puts reoperation or recurrence at around 5%. Its characteristic complication — suture extrusion, at 5.4% — is dealt with in clinic.

In exchange, surgery involves what the implant avoids: an incision and a scar, even though it stays hidden in the groove behind the ear. That is the real argument in the implant’s favour and it deserves saying.

There is also a middle route that we do perform: the percutaneous technique, which works with sutures through needle punctures and leaves no scar line. Its indication is narrow — mild cases with a deficient antihelical fold — but it leaves nothing inside.

Why we do not offer it

With all of the above, our position is this: given that there are techniques with decades of follow-up and reoperation rates of around 2-5%, we find no sufficient reason to take on a permanent implant whose long-term behaviour is described better by those who developed it than by those who have followed it up since.

That does not mean anyone who offers it is doing it badly. It is a device with regulatory approval, with a large published safety series, and there are thoughtful surgeons who use it in selected cases. It is a clinical decision, and this is ours. If your surgeon proposes it and explains these figures to you, they are doing their job.

If you already have an implant

Two things.

If you are well and notice nothing, nothing needs doing: there is no recommendation to remove implants that are not causing problems.

If you can feel the implant under the skin, if it shows through, if the area becomes irritated or if there are signs of infection, that does need looking at. In the published series, visibility and skin erosion are the most frequent reasons for revision. We can assess it, and if removal is appropriate, it is removed.

What to ask if it is offered to you

• Which cause predominates in my ear? If it is not the antihelix, the implant is not the answer.
• How many have you placed and with how much follow-up?
• What happens if it becomes noticeable or shows through? Who covers the removal?
• What surgical alternative would I have, and why are you ruling it out?
• What proportion of your patients have asked you to take it out?

That last one is the useful question, and it is the one the pilot study answers with 54%.

Frequently asked questions

What is earFold?

A metal alloy implant, a few millimetres long, placed under the skin of the ear through a small incision, which folds the cartilage of the antihelix to bring it closer to the head. It is placed under local anaesthetic and the implant stays inside permanently.

Is it better than an otoplasty?

They are different things. The implant acts only on the antihelical fold; surgery can also reduce or reposition the concha, remove skin and correct the lobe. And the body of evidence is very uneven: otoplasty has meta-analyses with thousands of patients and years of follow-up, while the implant has small series or short follow-up.

Do you offer it at ICPM?

No. With alternatives that have decades of follow-up and reoperation rates of around 2-5%, we find no sufficient reason to take on a permanent implant. It is our clinical judgement, not a criticism of those who use it.

Can it be removed?

Yes, and in fact removal is a significant part of what has been published: in the pilot study 21 of 39 patients requested it, and in an independent 2025 series it was removed in 6 of 19 because of complications.

What complications does it have?

Those described are visibility or show-through of the implant under the skin, skin erosion, infection, extrusion and hypertrophic scarring. In the largest series, 9.7% of patients had an adverse effect requiring intervention, with skin erosion in 3.7%.

Does it really leave no scar?

It leaves a small incision, much smaller than that of conventional surgery. That is its real advantage. The question is what you accept in exchange: a permanent foreign body under thin skin.

I have been told you can see the result before it is placed. Is that true?

Yes, and it is a genuine advantage of the system: it allows the correction to be previewed by marking the position on the ear before anything is implanted. Conventional surgery does not offer that.

I already have one and I am fine. Do I have to have it taken out?

No. There is no recommendation to remove implants that are not causing problems. If at some point it becomes noticeable, shows through or the area becomes irritated, then it is worth having it looked at.

Is there a scar-free option that you do offer?

The percutaneous or incisionless technique, which places the sutures through needle punctures and leaves no scar line. Its indication is narrow: mild cases whose only problem is the antihelical fold. Unlike the implant, it leaves nothing inside.

Sources

• Kang NV, Kerstein RL. Treatment of Prominent Ears with an Implantable Clip System: A Pilot Study. Aesthet Surg J. 2016;36(3):NP100-16. PMID 26673575 — 39 patients aged 7 to 57, 131 implants in 75 ears, with a minimum follow-up of 18 months: 18 patients kept the implants permanently and 21 requested their removal at 6, 12 or 18 months; complications in 8 patients (extrusion, infection, hypertrophic scarring and a pointed deformity).
• Kang NV, Sojitra N, Glumicic S, Vlok JA, O’Toole G, Hannan SA, Sabbagh W. Earfold Implantable Clip System for Correction of Prominent Ears: Analysis of Safety in 403 Patients. Plast Reconstr Surg Glob Open. 2018;6(1):e1623. PMID 29464160 — 403 patients and 1,200 implants: adverse effects requiring intervention in 39 patients (9.7%), implant revision in 17 (4.2%) mostly for visibility, skin erosion in 15 (3.7%) and infection in 7 (1.7%); no bleeding, haematoma or adverse scarring. Only 145 patients (36%) came back for review, at a mean of 7.7 months.
• Pauwels J, Cambier B. The Long-term Results of Earfold Implantable Clip for the Correction of Protruding Ears. J Plast Reconstr Surg. 2025;4(2):69-74. PMID 40657175 — 19 patients: six had a complication and had the implant removed, and one further patient requested removal, which led the authors to discontinue its use.
• Kang NV, Sabbagh W, O’Toole G, Silberberg M. Earfold: A New Technique for Correction of the Shape of the Antihelix. Laryngoscope. 2018;128(10):2282-2290. PMID 29658102 — Description of the technique and comparison with conventional otoplasty; it is the reference for how the device works and for previewing the result.
• Kaleeny JD, Janis JE. Otoplasty Surgical Techniques and Clinical Outcomes: A Practical Review. Plast Reconstr Surg Glob Open. 2026;14(1):e7404. PMID 41567352 — Meta-analysis of 18 studies, 1,590 patients and 3,060 ears, with a mean follow-up of 24.5 months: combined recurrence 2.8%, reoperation 2.1% and suture extrusion 5.4% as the most frequent complication. It is this page’s comparator.
• Sadhra SS, Motahariasl S, Hardwicke JT. Complications after prominent ear correction: A systematic review of the literature. J Plast Reconstr Aesthet Surg. 2017. PMID 28602268 — 28 studies and 3,493 patients: reoperation or recurrence at around 5%.
• Salmerón-González E, García-Vilariño E, Gutiérrez-Ontalvilla P, Miró-Rubio I, López-Blanco EM. Evaluation and comparison of two different cartilage-sparing techniques in 356 otoplasties performed in children. Ann Pediatr Surg. 2018;14(3):143-145. DOI 10.1097/01.xps.0000535042.94193.2 — The ICPM team’s own study: comparison of two cartilage-sparing techniques in 356 otoplasties performed in children.

Book your consultation

If you are considering an implant, the question that settles the decision is not which is better: it is which cause predominates in your ear. If it is not the antihelical fold, the implant does not address your problem, and that is settled in five minutes of examination.

At the assessment we will tell you which technique fits your case, what the alternatives are — including the one that leaves no scar — and what result is realistic. And if you still think the implant is for you, at least you will go with the questions ready.

Clinical confirmation by the surgeon

Dr Enrique Salmerón González

Specialist in Plastic, Aesthetic and Reconstructive Surgery
Registration no. 46/4624077

Dr Elena García Vilariño

Specialist in Plastic, Aesthetic and Reconstructive Surgery
Registration no. 46/4624503

Last reviewed: 6 September 2026. This content is for information only and does not replace an individual assessment by a healthcare professional.