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 Apple).…
- GMDN category: Hearing aid fitting/programming application software
Intended purpose
The Hearing Test Feature is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is an over-the-counter air-conduction hearing assessment intended to profile hearing ability and to produce an audiogram without the assistance of a healthcare professional. The Hearing Test Feature is intended for use by individuals 18 years of age or older.