Device typeAudiometric/hearing device software: A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).
FDA categoryActive Implantable Bone Conduction Hearing System, Implant, Hearing, Active, Middle Ear, Partially Implanted
Device ID09008737531065
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information