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
Device ID09321502074193
Catalog numberP2101583
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information