About BIGGO

Our product portfolio includes behind-the-ear, in-the-ear and body-worn hearing aids, designed to address different user needs.

BIGGO's hearing aid range includes BTE, ITE and body-worn products for hearing compensation in people with mild to moderate air-conduction hearing loss, within each model's intended use and instructions.

Selected advanced models feature 16-channel digital chips, millisecond-level noise reduction and feedback suppression, WDRC wide dynamic range compression and AI noise reduction for changing listening environments. Bluetooth 5.3 is available on corresponding models for phone calls and music. These capabilities are model-specific and do not describe every product displayed on this website.

BIGGO holds a Chinese Class II medical-device manufacturing licence with a production scope covering Class II category 19 medical rehabilitation devices, and hearing aid registration certificates covering BTE, ITE and body-worn products. The registered products undergo the applicable electrical safety, electromagnetic compatibility, acoustic performance and biocompatibility tests required under China's NMPA framework. The scope of each licence, registration and test report applies to the identified products and manufacturing entities.

BIGGO has completed FDA establishment registration and device listing for applicable products. Classification and premarket requirements depend on the device type: the ESD category covers Class I air-conduction hearing aids with a 510(k) exemption subject to applicable limitations; wireless and other hearing aid categories can have different classifications and requirements. The correct category must be confirmed for each model.

FDA registration and device listing are not FDA approval or certification. A database entry does not represent approval, clearance or authorisation of an establishment or product. BIGGO works to keep product labels, instructions and registration information consistent with the applicable requirements.

For applicable Bluetooth-enabled hearing aid models, BIGGO has completed FCC equipment certification and obtained the corresponding FCC ID under the relevant Title 47 CFR requirements. Authorisation and technical requirements are assessed for each device and wireless configuration.

The FCC's hearing aid compatibility (HAC) rules principally concern the compatibility of telephone handsets with hearing aids. BIGGO considers electromagnetic compatibility and Bluetooth coupling during product development; compatibility must be checked for the particular hearing aid, phone and supported connection method.

BIGGO has completed CE conformity assessment under the EU Medical Device Regulation (MDR 2017/745) for the products covered by its certification. Hearing aids of the relevant type are generally Class IIa devices, with notified-body involvement in quality-system and technical-documentation assessment.

BIGGO has established an MDR-oriented quality management system and obtained a notified-body CE certificate. Applicable products also meet the RoHS substance restrictions under Directive 2011/65/EU. Market placement within EU member states remains subject to the certificate's scope and the other applicable regulatory obligations.

BIGGO holds ISO 9001 and ISO 13485 quality management system certifications, supporting controlled and traceable processes across research, design, production and after-sales service. Certification applies within the scope stated on the relevant certificates.

Hearing health is closely connected to quality of life. BIGGO prioritises product safety, reliable performance and user experience, following the medical-device regulations and quality standards applicable to each market. For healthcare institutions, hearing care centres, distributors and brand partners, we offer services from OEM/ODM product customisation to regulatory documentation and certification support.