Device Dossier
Hearing aid remote control
Device Dossier for Hearing aid remote control (Hearing aid remote control, Class IIa, sponsor WS AUDIOLOGY). ARTG record, intended purpose, GMDN category…
- GMDN category: Hearing aid remote control
Intended purpose
An application software program intended to be used for adjustment of hearing aid acoustical settings (e.g., volume, program changes) by the patient. It is intended to run on a dedicated hearing aid remote control or an off-the-shelf portable computerized device (e.g., smartphone, tablet, laptop), with a wireless connection to the hearing aid.