Health Inspectorate warns against counterfeit hearing aid sold on AliExpress

Latvia's Health Inspectorate (VI) is warning residents against purchasing a hearing aid with model number 5216B sold on the e-commerce platform AliExpress, after determining the product is counterfeit.

The VI received information about the device from Belgium's competent authority. The listing advertised the hearing aid as a rechargeable medical device featuring Bluetooth connectivity, 16 sound channels and noise suppression capability.

Signs of forgery found

When the Belgian authority assessed the device, it found indications that the manufacturer's identity, the data of the European authorized representative, and the conformity marking had all been falsified.

The product listing named the Chinese company Austar Hearing Science and Technology as the manufacturer, with the Belgian firm Obélis S.A. listed as its authorized representative in Europe. However, Austar Hearing Science and Technology confirmed that model 5216B does not exist and that it never developed or manufactured such a hearing aid.

The VI states that a third party fraudulently used the manufacturer's name, the authorized representative's details, and the CE marking together with a notified body identification number, creating a misleading impression that the product meets EU regulatory requirements.

Residents urged to check purchases

The Inspectorate is asking residents to check whether they have bought this particular hearing aid. Anyone who finds such a device on the Latvian market is asked to report it to the VI's Medical Device Surveillance Department.