FDA in the United States of America has established over-the-counter (OTC) hearing aids in 2022 to make them more accessible and affordable for adults aged 18 or older with mild and moderate hearing loss. It was established to improve hearing function and prevent Depression and Cognitive Decline. Our OTC hearing aids are also designed and manufactured to meet the objectives of FDA. Our OTC hearing aids can be used freely via smart phones with dedicated application software, including a patented brain training software with newly developed functions to improve hearing loss.