FAQ — Frequently Asked Questions  
  How common are baby head shape deformities?
  Why should parents pick Orthomerica’s line of products?
  Is it a cosmetic concern?
  Are STARscanner and STARband covered by insurance?
  How long does treatment take?
  How does the scanner work?
  Do any outside medical experts endorse Orthomerica?
  Is the scanner technology safe?
  How long does it take to make the headband?
  Which is better, CTI’s DOC Band or your STARband?
  Which is better, your STARband, STARlight or Clarren Helmet?
  Like everyone else today producing widgets in large volumes, you must have some small country manufacturing your headbands?
  Does Orthomerica have plans to introduce any new products?
   
 
 

How common are baby head shape deformities?

Studies vary, but most concur that roughly 20% of babies are born with a head shape deformity, also known as plagiocephaly. Science and societal trends, like increased time babies spend on their backs and cramped conditions in utero with multiple-baby births, have added to the incidence rate. With the cutting-edge data collection and analysis technology provided by the STARscanner and STARband’s success rate, treated babies grow up to have normal head shapes, growth and development, providing peace of mind for parents.

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Why should parents pick Orthomerica’s line of products?

By virtue of being the world’s largest headband manufacturer, Orthomerica’s experience is unmatched. Plus, its eye-safe scanner captures head shape dimensions in 1.5 seconds that are accurate to within 0.5 mm. This technology is much faster and more precise than any traditional technique. Most importantly, it results in an effective, least stressful treatment for the baby and parent. Orthomerica’s STARscanner is also the only one to show head shape changes in babies before, during and after treatment. This gives parents and clinicians – not to mention insurance companies – proof that treatment is effective.

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Is it a cosmetic concern?

Many insurance companies believe that it is. However, serious medical conditions can result as the baby grows if head shape problems are left untreated and if they’re not treated early enough.

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Are STARscanner and STARband covered by insurance?

Many insurance companies have historically considered them to be cosmetic issues, not medically necessary to treat. As advocates for the healthy, normal growth and development of babies with head shape problems, Orthomerica works to enable insurance coverage by:

Working with government, regulatory agencies and insurance companies to expand patient access and reimbursement for cranial headbands.
Asking parents to first verify whether their insurance plan covers orthotics and prosthetics, and specifically cranial remolding orthoses.
Suggesting parents and clinicians ask for the Orthomerica STAR family of products by name with insurance companies.
Directing clinicians to get pre-approval and provide 3-D head shape information collected via STARscanner to prove medical necessity of the headband.
Giving clinicians billing and coding tools to facilitate proper insurance filing.

Orthomerica also conducts an ongoing public awareness campaign and is implementing online educational programs and cranial remolding coursework in the curricula of such world-renowned institutions as UT Southwestern, Northwestern University and others.

If insurance doesn’t cover cranial remolding orthoses, parents should discuss payment plans with the clinician. If left untreated, babies’ developmental skills, vision, jaws and alignment of facial features may be affected.

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How long does treatment take?

For babies who begin treatment between 4 and 7 months of age, it usually lasts three to four months. Visits with the clinician are weekly or bi-weekly, and head measurements may be taken at each one.  This enables fine-tuning of the headband to ensure effective treatment.  Orthomerica knows the traditional casting process can be stressful for the baby and parent, which is a key reason why Orthomerica developed the STARscanner. The measurements are taken in 1.5 seconds instead of the 15 to 30 minutes it takes with plaster casting. Plus, the detailed head shape information it offers is unrivaled in the industry. It gives our parents comfort to see their babies’ head shapes improving over time.

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How does the scanner work?

Scanners are less intrusive than plaster casting, making the process easier on the baby and parents. The baby lies on the open STARscanner bed, which is similar to the weighing scale found in most pediatricians’ offices. The parents and clinician stand alongside, touching the baby, while a 1.5-second scan collects all the needed head shape measurements. The data is immediately viewable on the clinician’s computer and is emailed directly to Orthomerica to create a precisely fitting, custom headband. During future visits, STARscanner’s software offers unique reporting that shows changes in the baby’s head shape – a technology not offered through any other provider.

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Do any outside medical experts endorse Orthomerica?

Pediatric neurosurgeon Dr. Sterling Clarren paved the way in cranial remolding for babies with head shape problems by his creation of the first cranial remolding orthosis at Seattle’s renowned Children’s Hospital and Regional Medical Center in the 1970s. He was also the first to be published on the topic in 1979. Dr. Clarren and Children’s Hospital and Regional Medical Center selected Orthomerica to be the preferred manufacturer of his headband – the Clarren Helmet. Orthomerica is proud to team up with the industry’s forefather to continue giving babies the very best in cranial orthotic care. The STARscanner and STAR cranial remolding headbands are used at some the country’s top children’s hospitals, including Mayo Clinic and Children’s Healthcare of Atlanta.

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Is the scanner technology safe?

The scanner is a safe device. It is classified and cleared by the FDA as a Class I laser-scanning device because it emits very low-power laser energy. Other examples of Class I laser products include laser printers, CD players and CD-ROM devices. Orthomerica developed the STARscanner to meet Class I laser specifications to ensure patients’ safety. Many other scanning technologies, however, are Class II, which means their lasers are stronger and may not be as safe. Orthomerica urges parents to make sure whatever device they select has FDA clearance.

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How long does it take to make the headband?

Orthomerica understands parents will be eager to start treatment as soon as possible, and the STARscanner streamlines the whole process. It gathers immediate and accurate measurements that can be emailed directly to the insurance company and to Orthomerica to begin making the headband right away. This is important because the quicker the headband is made, the more effective the headband is. Alternately, if plaster casting is used, the impression is shipped to Orthomerica. Either way, manufacturing the headband takes just four days once the measurements or cast impression is received at Orthomerica.

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Which is better, CTI’s DOC Band or your STARband?

Orthomerica has treated more babies than any of its competitors and is the only provider with scanning technology able to show the baby’s head shape progress over time. Orthomerica believes parents find comfort knowing their baby is being treated by the industry leader.

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Which is better, your STARband, STARlight or Clarren Helmet?

No two heads are the same, which is why Orthomerica created different headband designs. Each is constructed differently to direct head growth where needed. For instance, the basic STARband design treats moderate to severe plagiocephaly and brachycephaly, while the bi-valved STARlight is for babies with severe scaphocephaly. The cranial specialist will determine which headband is needed.

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Like everyone else today producing widgets in large volumes, you must have some small country manufacturing your headbands?

Orthomerica makes more headbands than any other provider around the globe, but maintains quality controls by having their own, trained technicians make them in our 70,000-square-foot manufacturing and distribution center in Orlando, Florida.

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Does Orthomerica have plans to introduce any new products?

Orthomerica is dedicated to remaining the leader in providing products for treating babies with head shape deformities, and continues its research and development in that regard. Visit www.starbandkids.com, or our corporate web site www.orthomerica.com, for updates.

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Resources
Caregiver Guide
 
 
- Spanish (available soon)
Repositioning Guide
 
 

STARband Kids
c/o Orthomerica Products, Inc.
6333 North Orange Blossom Trail, Orlando, FL 32810

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Please direct all inquires to your medical practitioner.

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