874.3430—Middle ear mold.
               		
               	 	
               	 	
               	 	               	 	               	 	               	 	               	 	
               	 	
    
        
        (a) Identification.
         A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. The device permits an ample air-filled cavity to be maintained in the middle ear and promotes regeneration of the mucous membrane lining of the middle ear cavity. A middle ear mold is made of materials such as polyamide, polytetrafluoroethylene, silicone elastomer, or polyethylene, but does not contain porous polyethylene.
     
    
        
        (b) Classification.
         Class II.