What is the FDA?
The FDA, or Food and Drug Administration, is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.
The FDA is a leading organization that is recognized worldwide.
Why has the FDA approved the STARband family helmets, the STARscanner, and the SmartSoc Screening Systems?
The STARband family of 5 helmet designs as well as the STARscanner and the SmartSoc screening systems are FDA approved.
STARband helmets have been approved by the FDA for two reasons. First STARband helmets comply with FDA enforced safety protocols. Second, they perform the function they are designed to carry out, which is to correct the shape of the skull.
The FDA has also approved the STARscanner and the SmartSoc scanning systems due to the following:
- Scanning accuracy
- Reliability to determine the severity of the head shape deformity
- State of the art comparative reporting capabilities, verifying the effectiveness of the STARband helmet.
What Do You Do on the First Visit to CRANIAL Tedavi Merkezi?
Our cranial specialists will discuss your baby's history with you to provide an accurate assessment and recommendation. They will also inform you about the STARband helmet treatment.
In most cases, our cranial specialists will take clinical pictures of your baby. The photographs taken of your baby's head shape deformity at the beginning of the treatment will be filed and will also be a reference for the process of helmet treatment continuation. Then, after some physical tests, your baby's skull shape will be scanned with the STARscanner or the SmartSoc systems which are approved by the FDA. The results from the report will be compared to the CHOA (Children’s Hospital of Atlanta) severity scale, which has been validated by research. Then the severity of the head shape deformity will be shared with you. A copy of the report will also be given to you and your doctor. In the report, the quantitative measurements of the skull showing the deformity in millimeters and the image of the head shape deformity will be presented.
After starting the STARband helmet treatment, the improvement will be compared with periodic scans. A copy of the comparison report will also be shared with you and the baby’s physician.
What Will Happen Next, If My Baby Needs a STARband Helmet?
Once you as a family have decided to start the treatment, the STARband will be fitted to your baby within 7-14 days. In the first week after the fitting, you will be educated on how to check your baby's skin during the adjustment period program. In the first five days after the Starband has been fitted, your baby will wear the helmet for 23 hours a day. You will only remove the helmet for bathing, skin control and cleaning. On your next visit about a week later, the technician will check how the helmet holding up and answer your questions. The frequency of subsequent visits is usually every 2-3 weeks, but will vary according to the baby's age, head shape deformity and the progress of the treatment. At each appointment, the cranial specialist will check to see if STARband helmet is properly placed on your baby's head, that there is no discomfort to the baby's skin and that the helmet is functioning properly.
At your follow-up visits, the cranial specialist will make some adjustments on the helmet. Before your next visit, if you think your baby’s helmet needs to be adjusted, call your technician immediately.
How Long Will My Baby Need To Wear the STARband?
The STARband helmet treatment usually takes about 3-4 months if treatment is started prior to 6 months. Studies have shown that it becomes harder to achieve the targeted correction of the head shape in infants over 8 months of age due to a decrease in the rate of brain growth. However Significant improvement can still be achieved. Although early diagnosis is ideal, STARband treatment can still be successful for up to about 18 months. That is why it is recommended to start the treatment at 10-12 months at the latest. As age increases, the growth of the head slows down and the bones thicken, so recovery is much slower.
How Will I Know When My Baby’s Treatment Is Over?
The technician will document reports taken from STARscanner or SmartSoc and clinical pictures of the baby's head shape during the treatment program. Periodically, the first and current scans will be compared to see how much improvement has been made. Typically, the STARband treatment will be over when the head shape has achieved the targeted symmetry and proportion. The final decision will be based on the comparative report and head shape images shared with you and your doctor.
Who manufactures the STARband Head Remolding Orthoses
Orthomerica Products Inc. designs and manufactures many unique Cranial Remolding Orthoses, such as the FDA (American Food and Drug Administration) approved side opening STARband & STARlight.
Orthomerica’s objective is to provide high-quality education and support for orthotists, therapists, doctors and parents for the treatment of infants with head shape abnormalities. Orthomerica is in constant communication with its Certified Orthotist team, providing online courses and training programs worldwide.
Orthomerica has trained thousands of certified cranial specialists and provides the STARband treatment program all over the world. Orthomerica is committed to making the best cranial remolding orthoses and providing clinical training worldwide.
Can head shape deformities be treated with a helmet only during infancy?
The STARband helmet treatment is only applied to the infants with head shape deformations between 3-18 months of age. Older children or adults cannot benefit from the treatment. After 18 months of age, sutures naturally close in the skull. In addition, at this age, the skull will have reached 85% of adult age growth.
However, STARband helmets are used in older children for protective purposes only after surgery or head trauma.
Do you charge for the STARscanner or the SmartSoc Scanning and evaluation at visits?
There is absolutely no charge for your visits to CRANIAL Tedavi Merkezi or for the scanning with the STARscanner and evaluation. Our cranial specialist will discuss with you what can be done to improve the deformity of your baby's head or face, the type of deformity and how much of a deformity your baby has. If the asymmetry or flatness severity requires STARband helmet treatment, our cranial specialist will advise you to start the treatment.
There is no charge for your visits regardless of frequency, such as follow ups after your baby’s physiotherapy for tension in the SCM muscle in the neck or measuring the response to repositioning.
Does My Baby’s Head Deformity Have Any Negative Effects on the Brain?
There has been no scientific data found to support that deformational head shape abnormalities have a detrimental effect on the brain. Even in severe and very severe deformities, there has been no damage found to the brain.
However, if one or more sutures are closed (craniosynostosis), the brain can experience intracranial pressure. This is because there is no additional room for growth inside the skull due to the closed sutures. Consequently, the skull becomes deformed. Due to the intracranial pressure, there can be severe effects on hearing and vision. Furthermore, motor and mental developmental delays can result. In such cases, it is important to operate on babies in the earliest months.
Does the STARscanner Data Acquisition System Emit Radiation?
No! The STARscanner data acquisition system does not emit any radiation. It is a non-invasive scanning system. The system is approved by the FDA (American Food and Drug Administration) and takes only the surface measurement of the skull.
Is the STARband Helmet Harmful to My Baby’s Skull, Brain, or Development?
NO! The STARband treatment does not do any harm to your baby’s skull, brain, or his/her physical and psychological development.
The goal of the STARband helmet is to correct the skull which is deformed due to external factors. Just as there is no damage to the development of the brain due to the deformation of the skull, there is no harm to the brain during the correction process with the STARband treatment.
So far, more than 500,000 babies have benefited from the STARband helmet treatment. Babies continue their normal activities and developmental progress. Since 2000, neither negative physical nor psychological developmental effects have been observed due to the use of the STARband helmet.
How Much Does the STARband Helmet Weigh? Will the weight of the helmet put strain on my baby’s neck?
The STARband helmets are fitted to infants at around three months of age since they can hold up their head using their neck muscles. The total weight of a STARband helmet is between 170 and 220 grams. This weight is exceptionally light, and your baby will be able to wear the helmet without any problems. The weight slightly differs for each child depending on age and helmet design.
After Treatment, Does My Baby's Skull Have the Risk of Flattening Again?
Absolutely not! After the STARband helmet treatment, there is no such risk. External factors that cause flatness (such as prolonged lying on the back, complications at birth and so on) will not be present since your child will continue to grow and reach developmental milestones, such as sitting, and turning while sleeping. In addition, the skull will be harder, and the sutures will be nearly closed.
Will my 8-month-old baby's flatness get worse if it is not treated?
During the 6th month, most babies start to sit during the day and can turn to the right or left in a reclining position. Therefore, it is not usually observed that the flatness present in the skull worsens. On the other hand, if the baby does not receive helmet therapy, improvement will not be seen, especially in moderate to severe cases.
My baby is only 3 months old. Could I wait and visit your center for measurement and evaluation in the 6th month?
Monitoring the development of your baby's head from the earliest age is important. First, to identify the severity of the flatness using quantitative measurements instead of relying on subjective evaluation. Second, to monitor the response to repositioning efforts using comparative reports.
Remember that your visits, measurements, and evaluations are conducted free of charge at our centers.
Do You Operate on Babies that You have Treated with Helmet Therapy
No, we do not! Infants with deformational/positional head shape deformity do not require any surgery. Corrections to the skull are made solely with the STARband helmet treatment. The criterion is that infants’ sutures must be open. However, for patients with craniosynostosis who have closed sutures, a helmet is fitted to correct skull deformity after having less invasive endoscopic strip craniectomy surgery. STARband helmets are rarely used after open surgery, except in cases where not enough correction was achieved during the operation.
Can STAR band Helmet Be fitted to an Infant With a Premature Closed (Craniosynostosis) Suture without an Operation?
No, this is not recommended! Although it sounds nice, fitting a helmet to a baby with a premature closed suture is dangerous. If the suture is still closed and a helmet is fitted, the baby’s skull and brain growth would be impeded.