Nuheara Receives FDA Clearance for Self-Fitting OTC Hearing Aids and Launches HP Hearing PRO
Australian hearable pioneers Nuheara announced that the company has received the "historic and first of its kind" FDA 510(k) premarket clearance for both an 874.3325 Self-fitting Hearing Aid and the 800.30 Over The Counter (OTC) hearing aid classification. This gives clearance for Nuheara to launch a "Self-Fitting Air-Conduction Hearing Aid, Over The Counter" product, which will be launched in the US market as the HP Hearing PRO.