Xiamen NewSound Technology Co.,Ltd

Xiamen NewSound Technology Co., Ltd. specializes in hearing aids, offering a variety of models to address different hearing needs. Their portfolio includes rechargeable hearing aids like the ASANA PRO 800 and VIVO Pro 400, as well as non-rechargeable options such as the VIVO 206 and Primo E101. They also provide customizable solutions like the Puretone and specialized devices, including the BEE III 800 and Rocker 201, which cater to diverse user requirements.

The company is headquartered in China. While the specific location within the country is not provided, this geographical context is relevant for understanding the manufacturer’s regulatory and operational framework, particularly when assessing compliance with international standards and market-specific requirements.

The manufacturer’s devices are registered in the euDAMED database, which is the official European Union database for medical devices. This registry is used to track devices placed on the EU market, ensuring transparency and compliance with regulatory requirements.

The company’s devices fall under EU Class IIa, which is the second-lowest risk classification for medical devices in the European Union. This classification applies to devices that pose minimal risk but still require compliance with specific safety and performance standards, such as hearing aids, which are considered low to moderate risk.