Our Certifications

Internationally Recognized Quality Standards for Hearing Aid Manufacturing

ISO

ISO 13485

Medical Device Quality Management

CE

CE

European Compliance

FDA

FDA

FDA-Ready Products

MDR

MDR

Medical Device Regulation

FCC

FCC

Electromagnetic Compatibility

RoH

RoHS

Hazardous Substances Compliance

GMP

GMP

Good Manufacturing Practice

TUV

TUV / SGS

Factory Audited

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