The non-operative correction of congenital ear anomalies

5% of Dutch babies is born with a congenital ear anomaly. These anomalies may
lead to bullying at a young age, causing psychosocial consequences to affect
the child. Due to this reason, children often want an early treatment, which is
only possible through operative correction at the minimal age of 5-7. Such a
surgery, also known as an otoplasty, will not always solve the psychosocial
consequences, while children may experience additional ones due to the surgery.
Possible surgical complications, such as hematoma, excessive scarring or skin
necrosis, may lead to additional operative interventions.
Since the twentieth centrury, a new treatment method has arisen; ear molding.
Ear molding uses external pressure to reshape the ear to its normal shape.
Treatment is initiated at a neonatal age, which leads to evasion of surgical
complications and bullying, including their psychosocial consequences. Since
2010, a system has been developed able to treat almost all different kinds of
ear anomalies through a standardized use, the EarWell Infant Corrective System.
Research has shown that more than 90% of treated ears shows favorable,
satisfactory results. Despite being researched in multiple countries, EarWell
and ear molding remain relatively new techniques in need of further
investigation before it can root in Healthcare.

Through this research, we want to further investigate the concept of ear
molding through the use of the EarWell Infant Corrective System, this time in
the Dutch population. We hope to investigate the opinion on the treatment
within the Dutch population and evaluate the results of its use. Eventually, we
hope to collect enough evidence for the effectivity and satisfaction in an
attempt to let ear molding be included in insured healthcare.

Neonates will be included and be treated for their ear anomaly with the EarWell
system. They will come to follow-up visits every 2 weeks to evaluate correction
grade and complications. Treatment will last a minimal of 6 weeks. If there is
no correction after 6 weeks or if complications arise which cannot be solved
through moving the system, treatment will be terminated. Collected data will be
used. With every visit, a questionnaire will be filled out.

Treatment will take place in the following manner:
1. Patients will come to the outpatient clinic with their parents for treatment
information and consent.
2. The treatment system will be applied if parents agree with the treatment.
3. Every two weeks, patients will return to the outpatient clinic to evaluate
the treatment effect.
4. If after 6 weeks, no effect is objectified by both parents and physician,
the treatment will be terminated.
5. If complications such as pressure ulcers are seen during the treatment
period, the system will be reapplied to relieve pressure on the site of the
pressure ulcer.
6. If complications arise that are untreatable through temporary relief of the
system or topical treatment, the treatment will be terminated.
7. Treatment will be continued for two weeks after stabilisation of correction
8. In case parents do not give their consent to start treatment, they will be
asked to return at 6 months of age and at 12 months of age to evaluate the
self-correction of the ear anomaly.
9. In case treatment needs to be terminated due to complications or
ineffectiveness, participants will be asked to return at 6 months of age and at
12 months of age to evaluate the self-correction of the ear anomaly.

There have been several reports of potential complications. There have been
reports of skin excoriations or pressure ulcers and skin irritation/rash. All
of the complications were minor in kind and most spontaneously resolved.
Another potential *risk* described in the studies is the recurrence of the ear
anomaly. This often involved the prominent ears, which have been known to
develop during the first year of life, possibly due to posterior pressure from
lying supine.
Benefits of the treatment outweighed the risks involved. Due to the high
satisfactory correction rate, most children no longer needed operative
treatment later in life, which would have exposed the children to more severe
possible complications, such as skin necrosis and hematoma. Correction also led
to not being exposed to bullying, which annihilated the psychosocial
consequences children experienced from this ear-related bullying.