Device Dossier

Hearing aid fitting/programming application software

Device Dossier for Hearing aid fitting/programming application software (Hearing aid fitting/programming application software, Class IIa, sponsor…

Intended purpose

A software program intended to assist with the evaluation of a patient’s hearing capability, and/or function of a hearing aid including programming according to patient-specific requirements. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet) with a wireless connection to the hearing device, or on a remote control.

TGA Public Summary