Cranial Technologies

Clinical testing shows a least a >90%+ success rate (Byrd 2010) 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.

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.

EarWell is a 4-6-week course of therapy for each procedure. 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 provider 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 provider.

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

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.

No, the ear system 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.

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.

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.

We strongly advise parents to gently wash the hair and skin around the Ear system 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).

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.

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.

The latest studies show that nearly 1 in 2 (47%) infants today have some degree of plagiocephaly. 1 in 4 babies have a severe enough degree that experts would recommend treatment with a cranial orthotic.

Yes, having babies sleep on their backs saves lives! According to the American Academy of Pediatricians, the move to back sleeping, known as the Back to Sleep campaign, has reduced SIDS (Sudden Infant Death Syndrome) by more than 50%.

Plagiocephaly won’t have any lasting harmful effects on your baby’s neurological development. However, if left untreated it is possible the head will remain misshapen into adulthood.

Simple at-home practices including supervised tummy time and repositioning techniques are known to prevent and improve abnormal head shapes up until about four months of age. Additionally, limiting the use of convenience devices, such as car seats, infant carriers and swings, is also recommended.

Yes! Evaluations are 100% free of charge. Our evaluations produce an accurate measurement of your baby’s head shape to determine if they will benefit from treatment. From there, parents can make an informed decision on the best course of treatment for their little one(s).

We typically treat infants between the ages of 3 to 18 months.

The optimal time to begin treatment with a DOC Band is between 4-6 months of age. However, the DOC Band is a proven plagiocephaly treatment for babies 3-18 months of age.

Our banded treatment relies on natural brain growth which is rapid during the first 6 months of life, steady from six to 18 months, then slows through 24 months of age. Starting treatment early has been shown to reduce overall treatment time.

The treatment of plagiocephaly is time sensitive. Because the shape of the head is fully formed by age 2, cranial helmet therapy can no longer correct flattened areas.

You can follow our at-home assessment to get a better understanding of your baby’s head shape.

Please note that this assessment is not meant to replace the diagnosis of a medical professional. If you’re concerned about your baby’s head shape, you can schedule a no-cost evaluation at the clinic location nearest you.

On average, treatment times are between 5 weeks and 4 months. However, treatment time will depend on your baby’s age and the severity of the condition.

The earlier treatment begins, the quicker the result can be achieved. The DOC Band relies on natural brain growth, which is rapid during the first 6 months of life, steady from six to 18 months, then slows through 24 months of age. The more severe the condition, regardless of age, the longer it will take to correct the shape of the head.

Starting treatment earlier between the ages of 4 and 6 months, a period of rapid head growth, has been shown to reduce overall treatment time. Though, noticeable improvement can be achieved using the band between three and 18 months of age.

Each band is custom-made for your baby’s head and is made within 7–14 days following the imaging appointment.

Typically, we will adjust your baby’s DOC Band every 1-2 weeks, depending on your baby’s growth rate.

The band must be regularly adjusted to accommodate head growth and optimize your baby’s outcome. Follow-up visits also ensure the band fits your baby and is functioning properly.

You’re not alone – there’s an extensive network of parents of DOC Band babies who have found ways to make the treatment process fun and engaging. Many parents will decorate their little ones’ DOC Band or take the opportunity with curious bystanders to educate them about plagiocephaly.

You can also join our online DOC Band Parent Support Group to chat with others who currently have or have had a baby in helmet therapy.

Research has shown if left untreated, a misshapen head can persist into adolescence and adulthood. Since the shape of the head is fully formed by age 2, cranial helmet therapy is no longer a viable treatment option beyond this point.

When deciding whether or not to move forward with the DOC Band, it’s important to consider some issues that may arise in later years without treatment:

• Noticeable facial asymmetry
• Poor-fitting eyeglasses and/or safety equipment like sports helmets
• Visible flat areas with short or cropped hairstyles
• Jaw misalignment resulting in a crossbite or underbite

Due to the increasing severity of head shapes today, our research has not shown self-correction in most cases. Remember that an external force was present to cause the deformity, therefore an external force must also be present to correct it. Once your baby is sitting up and moving about, the skull will continue to harden without any external force directing the head’s growth into a symmetrical shape.

For children less than 4 months old, supervised tummy time and repositioning techniques can sometimes be enough to correct an abnormal head shape.

Yes, twins (or multiples) can both be treated simultaneously. In fact, twins tend to have a higher risk of plagiocephaly due to restricted space in the womb.

The DOC Band is a medically necessary treatment, meaning that we only recommend treatment for babies who present with moderate to severe head shapes. Our no-cost evaluations provide a detailed report of the baby’s head shape so that parents can make an informed decision about treatment.

It is ultimately up to the parent(s) to decide the best course of action for their child.

Yes, a prescription is necessary to begin treatment.

The DOC Band is a class II FDA regulated orthotic device therefore must be prescribed by a physician or other state approved medical provider. The type of provider who must prescribe the DOC Band may vary by insurance plan or state law.

Often, all it takes a simple request for a prescription. You can ask your doctor at your next appointment. Or, feel free to schedule a no-cost evaluation at one of our clinics where we will provide you with a recommendation regarding whether to treat or not that you can share with your doctor.

Because of our relationships with many local pediatric offices, if our clinicians recommend treatment for your baby, we may be able to help you with the process of getting the prescription from your doctor.

Because the shape of the head is fully formed by age 2, cranial helmet therapy cannot be used to correct an abnormal head shape in adults.

No, the DOC Band is not used to treat craniosynostosis but doctors may refer patients to Cranial Technologies after completing surgery.

Craniosynostosis is the premature fusion of one or more bony plates in the skull, often resulting in restricted brain growth and an abnormal skull shape. The condition can be corrected with surgery followed by post-operative helmet therapy.

Since the band is custom-made to fit your baby’s head, adjusting to the band is usually a quick process, often in the matter of a day.

No, the DOC Band will not affect your baby’s personality or social development. It’s well reported that infants adapt easily to the DOC Band without issue.

In practice, we find that only ~15% of babies are recommended for a second band through treatment.

Most parents are pleased with their baby’s head shape after one DOC Band and do not continue treatment with another. It is possible, though, given that the severity, complexity, age and growth of each case is unique, that you and your clinician may decide your baby would benefit from a second DOC Band to complete treatment.

Please note that there is an additional cost if a second band is used for treatment. Although any decisions required will always be at your discretion and guided with the help our plagiocephaly experts on staff.

No, your baby will not experience withdrawals from the band once treatment is complete.

Although the DOC Band can easily become part of a baby’s personality, especially with some creative decorating, children are resilient and adjust quickly.

Yes, DSi technology is 100% safe for your baby. Independent safety experts have confirmed that the DSi is similar to an ordinary camera flash and poses no harm to your baby.

Yes, you’ll stay with your baby during the imaging process. You’ll be there to observe as the clinician positions your baby and quickly captures the image of their head shape.

The stockinette is used to smooth down your baby’s hair and conform to shape of the head. This allows the for the cameras to capture a highly accurate picture of your baby’s “true” head shape which is critical to creating a DOC Band with a precise fit.

To achieve the best possible results for your baby, every person who provides care to your baby (mom, dad, grandparents, aunts and uncles, babysitters, daycare employees, etc.) should understand how important it is to follow all treatment protocols carefully and consistently.

This includes measures like:

• Ensuring your baby wear the band 23 hours per day
• All growth adjustment appointments should be attended
• If needed, your baby's neck muscles should be stretched and exercised daily

Holes have been said to serve several purposes: To provide ventilation for the infant or to allow change to be seen through the helmet. Some orthotists use the holes to measure the depth between the helmet and the infant’s skull, to monitor change over time.

The DOC Band doesn’t have holes for several reasons:

• Holes drilled into the device can compromise the device’s structural integrity, much like the perforations in a sheet of paper
• Depending upon the location, the holes can trap fluids and cause swelling
• We’ve found there are better ways to assess progress than peering through holes

The outer shell of your baby’s DOC band is a blank canvas waiting to be personalized. You can decorate it using paint, stickers and other “child-friendly” materials. See our Decorating Guide for more tips.

Our Cool Car Tips offer some tips to keep your little one cool during those warm summer months.

To cancel or reschedule your initial no-cost evaluation consult appointment use this link: book.cranialtech.com/reschedule.

No fees apply for cancelling or rescheduling your appointment.

There is no cancellation or reschedule policy. Patients can cancel or reschedule up to the day of their appointment, we ask that you try to cancel or reschedule your appointment as soon as possible.

Yes, you can use our online cancel/reschedule too to make changes to your initial no-cost evaluation consult appointment. To cancel or reschedule use this link: book.cranialtech.com/reschedule.

Yes, once you reschedule, you will receive a confirmation email or message to verify the appointment changes. For cancellations, you will receive on screen confirmation but no email.

To reschedule or cancel your appointment you will need patient first name, patient last name, patient date of birth.

S1040-Cranial Remolding Orthosis is the one and only procedure code for the DOC Band (for Plagiocephaly and Craniosynostosis).

Could be any of the following depending on your specific insurance plan:

• DME
• Orthotic
• Prosthetic
• All other types of service

Due to individual insurance contracted rates and your specific policy benefits, we will be able to give a better quote of your estimated cost share once our Insurance Liaisons have verified your benefits after the no-cost evaluation.

Prior authorization is a pre-service review that is required by your insurance policy. Insurance typically reviews for either medical necessity, benefit coverage, or both. If authorization is not submitted prior to treatment, your insurance plan can penalize or deny paying for treatment solely on this basis. Additionally, many cases require waiting for a final determination before beginning treatment.

A pre-determination is a voluntary pre-service review. Your insurance plan will not penalize you for not submitting the review, but it is offered to you due to the specific nature of the DOC Band treatment. Like a prior authorization, the review is for medical necessity, benefit coverage, or both.

Neither prior authorization or a pre-determination is a guarantee of payment from an insurance provider, even when approved.

To maintain the quality of our product, the expertise of our staff, and consistency of our treatment process, the DOC Band is only available at our clinics and satellite centers. We are, however, growing and always looking for new locations to offer our patients more convenient care.