Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation number
874.3305
Review panel
EN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is a prescprition hearing aid.