DEVICE DETAILS
| NAME OF DEVICE | STARKEY EDGE AI IN-THE-EAR HEARING AIDS |
|---|---|
| ESTABLISHMENT NAME | BEST HEARING AID CENTRE SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB5867525-218172 |
| BRAND NAME | STARKEY |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Edge AI Hearing Aid Systems are air conduction Hearing Aids. Input to the device is in the form of sound waves, which are converted by a microphone to an electronic signal. This electronic signal is digitally processed utilizing digital signal processing (DSP) technology. The signal is amplified and shaped by internal DSP circuitry and firmware algorithms to compensate for the patient’s hearing loss. The resultant signal is converted to an acoustic output and presented to the patient’s ear canal. |
| DEVICE INTENDED PURPOSE | Air conduction hearing aids are wearable sound-amplifying devices that are intended to compensate for impaired hearing. The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients’ suffering from tinnitus. |
| VALIDITY DATE OF REGISTRATION | 01/12/2025 - 30/11/2030 |