Health Inspectorate warns of counterfeit hearing aid sold on AliExpress

Latvia’s Health Inspectorate has warned about a counterfeit hearing aid sold on the AliExpress online platform, LSM reports.

The Belgian competent authority informed the inspectorate about a device marketed as a rechargeable medical device with Bluetooth connectivity and 16 sound channels. An assessment found signs that the manufacturer’s identity, the details of its authorised European representative and the conformity marking had been falsified.

The product is listed under the name “Hearing Aid with Bluetooth 16 CHANNEL Hearing Aids Rechargeable for Deafness High Quality with Noise Cancelling audifonos”. The stated manufacturer is Austar Hearing Science and Technology of China, while the authorised European representative is Obelis S.A. of Belgium. The notified body is SGS Belgium, with notified body number 1639. The model is identified as 5216B.

Austar Hearing Science and Technology has said that model 5216B does not exist and that it neither designed nor manufactured it. The inspectorate said a third party had used the manufacturer’s name, the authorised representative’s details and the CE marking together with identification number 1639, creating a misleading impression that the product complied with European Union requirements.

Consumers are urged to check whether they have bought a hearing aid with model number 5216B. If such devices are found on the Latvian market, information should be provided to the Health Inspectorate’s Medical Device Supervision Division by calling 67081611 or emailing [email protected].