PMA with FDA
FDA Conclusion
In March 2020, Auralsplint Inc. PBC voluntarily submitted the Auralsplint treatment for Pre-Market Approval with the FDA. 9 weeks later, after several discussions, a conclusion was made declaring the Auralsplint a Class 1 Medical Device by definition requiring prescription by licensed veterinarians, as part of a whole treatment in clinic including routine exam and any other needed pathology to determine the 'cause' for the hematoma. It is Auralsplint's understanding the 'cause' of the hematoma is the ear has a broken blood vessel due to the actions by animal to shake the ears for relief from a condition. The condition is important to diagnosis and treat to keep from return behavior. In no way is the Auralsplint replacing a licensed veterinarian. However, with the Auralsplint in location, and the ear canal open and exposed, any underlying condition is treatable after installation. We would recommend the Auralsplint as a first line of defense for the aural hematoma affliction and the underlying conditions treatable at time of veterinary visit. If unable to have vet treat the affliction, then the layperson is left to treat themselves. The Auralsplint treatment kit is suitable for both clinical application, installation in the field, and by the animal owner at home through participation in ongoing study.
