At what age should the device be applied?
Clinical testing documents a 90% success rate when treatment is started before three weeks of age. New data suggests equivalent, or perhaps higher, success rates with a much shorter duration of treatment when the device is applied in the newborn nursery at or before two days of age.
How long does the correction take?
The average course of therapy for an EarWell™ procedure is between 4 and 6 weeks. A recent study from NY-Presbyterian Hospital indicates that if the procedure is initiated before the child is 48 hours old, the course of therapy may be reduced to 2 weeks. The guiding principle is that the ear should be held/retained in its normal shape until the cartilage has stiffened.
When is a child too old or too big for EarWell™ therapy?
While successful treatment has been reported in infants 4, 6, 8 and 10 weeks old, successful outcomes diminish sharply after three weeks of age. If the physician opts to apply EarWell™ after three weeks of age, the parents should be apprised of a decline in successful outcomes after that point.
Ears may also grow beyond the size of the Large Cradle in older, larger infants. The Technical Variations section provides recommendations for altering the Cradle to accommodate larger ears. Additionally, advances in motor skills and hand coordination introduce the possibility of the older child manually dislodging the device. If applied beyond the recommended dates of therapy, arm splinting should be considered.
Becon recommends beginning the procedure prior to 3 weeks of age.
What about preemies?
An apparent unique exception to the recommended timing of the initial application appears to reside with the premature infant. Although not clinically documented, nor necessarily recommended by Becon, preemie therapy initiation may be based on gestational age as opposed to their chronological age.
EarWell™ providers have reported the treatment of multiple premature infants with a chronologic age of up to 2 months and a gestational age of less than one week, with treatment success and outcomes matching those of the gestational age. Becon does not recommend beginning therapy on infants of less than 4 to 4.5 pounds nor later than 3 weeks post natal.
However, due to the reports of consistent successful outcomes for premature babies whose therapy was begun at a gestational age of 1 to 2 weeks, physicians may well want to consider these factors in their procedural decision.
What is the determination for selecting a 4- or 6-week course of therapy?
Becon recommends a 6-week course of therapy for each procedure.
Physician providers report that the duration of therapy can be reduced to 4 weeks under certain conditions. The type of deformity, its severity and the age of the patient are factors that can contribute to an abridged regimen.
“The earlier the better” has become a reliably accurate axiom for the conduct of any EarWell™ procedure. A child who is treated in the first post-natal week with a comparatively minor deformity (helical rim or Stahl’s) may become a candidate for a 4-week course of therapy. Upon removal of the Cradles at 4 weeks, the physician must make a subjective evaluation regarding the successful completion of therapy and the relative rigidity of the ear cartilage.
Conversely, any child who initiates therapy beyond a week and who presents more egregious types of deformity (prominent ear, cup ear, cryptotia) should be treated to a full, 6-week course of therapy (certain conditions may warrant expansion to 8 weeks).
The duration of EarWell therapy is a decision made entirely by the physician. As mentioned, Becon recommends a 6 week course of therapy for each EarWell procedure.