Cranial Molding Orthosis (Helmet Therapy)
The baby helmets used to reshape an infant's head are formally called "cranial molding orthoses" or "cranial remolding orthoses" (CRO), though they are commonly referred to as "helmet therapy" or simply "cranial orthoses." 1
Medical Device Classification
These devices are regulated by the FDA as Class II neurology devices and require premarket notification (510[k]) clearance before being placed on the market 2. The formal generic device category created by the FDA is "cranial orthosis," establishing both general and special controls to ensure safety and effectiveness.
Clinical Terminology
The medical literature and clinical guidelines consistently use the following interchangeable terms:
- Cranial molding orthosis (most common in guidelines)
- Cranial remolding orthosis (CRO)
- Cranial orthosis
- Helmet therapy (colloquial term)
Clinical Context
These custom-fitted helmets are worn 23 hours per day for several months to treat positional plagiocephaly (asymmetric head flattening), deformational brachycephaly (symmetric flattening), and deformational asymmetrical brachycephaly 1, 3, 4. The Congress of Neurological Surgeons guidelines recommend helmet therapy specifically for infants with persistent moderate to severe plagiocephaly after conservative treatment (repositioning/physical therapy) or for those presenting at an advanced age 1.
The devices work by applying gentle, consistent pressure to prominent areas of the skull while allowing growth in flattened regions, achieving correction through the infant's natural cranial growth during the critical period of infancy 5.