In a groundbreaking announcement, the U.S. Food and Drug Administration has approved the first over-the-counter hearing aid software device called Hearing Aid Feature. This software is designed to work with compatible Apple AirPods Pro headphones and is intended for individuals aged 18 and above with mild to moderate hearing impairment. The FDA’s decision represents a significant advancement in accessibility and availability for those suffering from hearing loss. The ease of use and effectiveness of the software has been demonstrated in a clinical study, showing comparable results to professionally fitted devices. This innovative approach aligns with the FDA’s commitment to providing safe and effective solutions for individuals with hearing loss.
https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software