SBO BERNAFON ENCANTA HEARING AIDS (BTE) - HSA Registration DE0509036
Access comprehensive regulatory information for SBO BERNAFON ENCANTA HEARING AIDS (BTE) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509036 and owned by SBO Hearing A/S. The device was registered on March 07, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The hearing aid is intended to amplify and transmit sound to the ear. It is indicated for bilateral or unilateral impaired hearing of sensorineural, conductive or mixed type ranging from a slight (16 dB HL*) to profound (95 dB HL*) degree of hearing loss, with an individual frequency configuration. Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief for patients suffering from tinnitus as part of a tinnitus management program. It is a feature built into the hearing aid itself. The target population is the adult population over 18 years of age.