Soundwave Hearing's Sontro OTC Hearing Aid Gains FDA 510k Clearance

Chicago-based Soundwave Hearing has announced receiving FDA 510k clearance for its Sontro^® Self-Fitting Over-the-Counter OTC Hearing Aids. The hearing aids, developed by a team of hearing industry veterans in Oak Brook, Ill, are one of the more intriguing entrants in the OTC market and will be offered at $749 per pair.

"The 510k FDA Clearance for the Sontro Self-Fitting OTC Hearing Aids is particularly timely, given the regulations for OTC hearing aids and the growing demand for telemedicine-based services,” said Anthony Florek, president and co-founder of Soundwave Hearing in a press statement. “We are extremely proud of our ability to create a personalized, self-fitting OTC hearing aid, a true milestone. It's a leap forward in making hearing healthcare more accessible, patient-friendly, and ensuring a brighter cognitive future for many,"

Sontro is a receiver-in-canal (RIC) hearing aid launched in January 2022 that uses a size 312 battery. The otoTune app, available for Android and Apple iOS, is designed to test your hearing in 3 minutes while wearing them. The aid then calibrates itself for your hearing loss and offers four listening programs (Quiet, Noise, Entertainment, and Automatic). The hearing aid also automatically adjusts to different sound environments.

According to Soundwave, Sontro OTC Self-Fitting Hearing Aids are the first self-fitting OTC hearing aids on the market to offer Automatic Mode Selection and Adaptive Directionality. Automatic Mode selection is designed to intelligently monitor the environment and automatically select the most appropriate sound mode to help the user hear their best in every listening situation, allowing them to move more seamlessly from quiet to noisy listening situations. Adaptive Directionality, now fairly common in advanced prescription hearing aids, enables users to follow a conversation easily by using directional microphones to identify speech in noisy environments like crowded restaurants.

Along with automatic mode selection and adaptive directionality, the device features 16-channel wide dynamic range compression (WDRC), noise reduction and feedback cancellation. It currently does not feature streaming for music, phone calls, or other media, although Soundwave has told HearingTracker it plans to offer this in a future version.

Soundwave reports that Sontro has a 45-day risk-free guarantee, 1-year warranty, and lifetime customer support. The hearing aids are eligible for FSA and HSA reimbursement.

Soundwave says its partnership with Amptify DTx makes Sontro one of the first OTC hearing aids to offer aural rehabilitation (AR), providing a hearing health coach, listening games, an interactive curriculum, and a support community. Purchasers of Sontro receive one month free of the Amptify program, which is an evidence-based AR program that uses a proprietary digital toolkit to provide ongoing and personalized hearing rehabilitation. Audiologists at the Audiovisual Speech Perception Laboratory at the Washington University in St. Louis School of Medicine developed the program.

A paper in the September 6, 2023 edition of Nature Scientific Reports examined the effectiveness of the otoTune app. Funded by Resonance Medical, LLC and Soundwave, this research suggests that a patient-controlled hearing assessment with the hearing aid and app in a non-clinical setting is statistically comparable to an audiologist-controlled hearing assessment in a clinical environment.

For more information about the Sontro OTC hearing aid, visit the Soundwave website.