Cearvol Wave Lite brings AI-enhanced hearing aid to OTC market with 40dB gain

Shenzhen-based Cearvol launched the Wave Lite on August 26, 2025, an over-the-counter in-the-ear hearing aid targeting mild to moderately severe hearing loss. The device delivers 40dB gain through AI 2.0 noise reduction and eliminates the need for professional fitting or audiologist supervision. The move extends the OTC hearing aid expansion that began after the FDA's 2022 deregulation, bringing consumer electronics manufacturers deeper into a market historically dominated by prescription devices.