Frequently Asked Questions about EarWell

What causes ear deformity?

Most abnormalities occur in the upper third of the ear and are caused by fetal ear development. It is often a failure of the tissue to properly migrate. Some other anomalies may be a result of positioning while in the uterus and others may be genetically driven (e.g. prominent ears).

At what age should the EarWell be applied?

Clinical testing shows a 98%+ success rate when treatment is started before 3 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 correction take?

The average course of therapy for an EarWell procedure is between 4 and 6 weeks. A 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.

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 any EarWell procedure. A baby who is treated in the first week of life 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 challenging 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.

Is the procedure painful to the child?

No. The child may cry during the application but not because there is any pain.

Is EarWell uncomfortable or will it interfere my baby’s sleep?

EarWell is painless and will not interfere with your child’s sleep. No special adjustments or precautions need to be taken with your baby’s sleeping position.

Will the EarWell affect my child’s hearing?

No, the EarWell has perforations and a front opening that permit the admission of sound waves. Its presence will not affect hearing while the device is on the child or after it is removed.

Is it necessary to shave my child’s hair?

Yes. The adhesive bond must be attached directly to the skin. If there is hair under the adhesive it can cause irritation and failure to hold the components in their proper position.

Does EarWell affect nursing?

EarWell should not impact nursing. We recommend that a soft cloth be strategically placed during feeding to prevent milk from entering the cradle of the EarWell.

Will EarWell Cause Skin Irritation?

The rare reported incidents have been limited to yeast infection following the untreated entry of milk or “spit-up” into the interior of the EarWell. It’s important to protect the EarWell from this type of spillage. If it does occur, call your provider and return for examination and cleaning. If any redness does occur, see your provider.

Skin redness can occur with the placement of an EarWell. The combination of the adhesive, alcohol wipes and alcohol pads or swabsticks can cause irritation to tender infant skin. Mild redness following removal of the device and after skin prep is common and not of concern. The adhesive used to attach the EarWell device is proprietary to Becon Medical Ltd., and was developed together with the 3M™ Company. It is a porous, hypoallergenic, continuous contact tape that has been extensively human tested for biocompatibility and biotoxicity.

There have been few reports of allergies despite its use on thousands of infants. When the rare allergy is observed, it typically is evidenced by a premature release of the adhesive with an underlying moist and erythematous skin. The skin may also have a rough and scaly texture, similar to that of eczema. The majority of these occurrences have been among infants with more severe “infant acne” or seborrhea (cradle cap), i.e., infants who already have more sensitive skin types. These reactions will not typically become evident until after one or two cradle applications. If you see any irritation of your baby’s skin, please contact your EarWell provider for evaluation and treatment right away.

Can The EarWell Get Wet?

We strongly advise parents to gently wash the hair and skin around the EarWell with a soft washcloth rather than immersing the baby’s head under running water, which can prematurely loosen what is called the “posterior cradle” (the bottom piece of the EarWell that attaches to the head).

Is My Baby 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 drop sharply after three weeks of age. If your provider agrees to apply EarWell after three weeks of age, you should be aware of a decline in successful outcomes after that point.

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 of age. 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.

When To Call Your EarWell Provider?

• At your initial call for evaluation
• If the posterior cradle (bottom piece of the EarWell that attaches to the head) becomes loose
• If milk or spit up gets inside the EarWell
• If baby develops a rash around or under the EarWell