Soundwave Hearing has obtained FDA 510k clearance for Sontro, its over-the-counter hearing aids.

Soundwave Hearing offers over-the-counter hearing aids that can be self-fitted and customized using AI and mobile technology. Its product, “Sontro Self-Fitting OTC Hearing Aids,” is designed for individuals over the age of 18 with mild to moderate hearing impairment and allows users to take an AI-based hearing test and adjust their hearing aid settings according to their personal preferences and requirements. The company’s companion app also enables features such as noise reduction, feedback cancellation, and adaptive directionality. 

Analyst Quicktake: Soundwave Hearing is the most recent hearing aid provider to benefit from the FDA’s decision to approve over-the-counter (OTC) sales of hearing aids to individuals with mild to moderate hearing loss. Last year, hearing aid provider Yes Hearing noted that this ruling would help raise sales and awareness for its hearing aids when it raised USD 10 million. Going forward, more interest might appear in the OTC hearing aid market now that companies have had time to take this ruling into consideration.