Soundwave Hearing Announces FDA Clearance for Sontro Self-Fitting OTC Hearing Aids and otoTune App

sontro self fit otc hearing aids
November 11, 2023

OAK BROOK, ILLINOIS – Soundwave Hearing has received 510k FDA clearance for its Class II Medical Device, Sontro® Self-Fitting OTC Hearing Aids, marking a significant step in providing affordable hearing aids to Americans. Leveraging the capabilities of mobile phones and innovative self-fitting AI technology, Soundwave Hearing introduces personalized customization for its Sontro Self-Fitting OTC Hearing Aids, eliminating common barriers to hearing aid accessibility.

A recent study in The Lancet underscores hearing loss as the primary modifiable risk factor for cognitive decline in older adults. Despite 37.5 million Americans experiencing hearing challenges, 80% of those who could benefit do not utilize hearing aids. Over-the-counter (OTC) hearing aids present a promising and cost-effective solution, with the aim of making hearing health accessible to everyone.

“The FDA Clearance for the Sontro OTC Hearing Aids is timely, given the regulations for OTC hearing aids and growing demand for telemedicine services. We are proud of our ability to create a personalized, self-fitting OTC hearing aid, a true milestone. It represents a leap forward in making hearing healthcare more accessible, patient-friendly, and ensuring a brighter cognitive future.”

–Anthony Florek, President and Co-Founder of Soundwave Hearing

What Makes Self-Fitting Sontro Hearing Aids Different?

sontroPersonalized Self-Fit:

    • Soundwave Hearing utilizes groundbreaking AI technology, allowing users to personally fit their hearing needs without predetermined settings. Each device is programmed based on the individual user’s specific hearing requirements.
    • How Does Soundwave Achieve Personalized Self-Fit?
      • The Sontro Self-Fitting OTC Hearing Aids, along with the otoTune® app, employ a 3-minute in situ hearing test to customize the self-fitting process (in situ: a hearing test administered while wearing the devices, paired to the app).
      • The patented otoTune app simultaneously tests both ears using the devices, providing clinically validated test results and programming tailored to the user’s unique hearing and listening needs.

Unique State-of-the-Art Customization:

    • Sontro OTC Self-Fitting Hearing Aids stand out as the first self-fitting OTC hearing aids on the market offering Automatic Mode Selection and Adaptive Directionality.
    • Why does this matter?
      • Automatic Mode selection intelligently monitors the environment, automatically choosing the most suitable sound mode to optimize the user’s hearing in various listening situations, facilitating a smooth transition from quiet to noisy settings.
      • Adaptive Directionality enables users to effortlessly follow conversations by utilizing directional microphones to enhance speech identification in noisy environments such as restaurants.

Aural Rehabilitation:

  • Soundwave Hearing’s collaboration with Amptify DTx places a strong emphasis on consumers’ hearing health. It stands as one of the pioneering OTC hearing aids to include Aural Rehabilitation with the purchase. This offering encompasses a hearing health coach, engaging listening games, an interactive curriculum, and access to a supportive community. [Learn More]

Soundwave’s Published Research:

  • A collaborative research study conducted in partnership with esteemed institutions has established that a patient-controlled hearing assessment, facilitated by a hearing aid in a non-clinical setting, is statistically comparable to an audiologist-controlled hearing assessment in a clinical environment. At the heart of this study is Soundwave’s acclaimed otoTune® app, utilized for patient-controlled hearing assessments. Noteworthy, Resonance Medical, LLC, and Soundwave Hearing, LLC, provided funding for the research, and the findings have been published in Scientific Reports, a respected and widely-read scientific journal. [Link to Study]

OTC Hearing Aid Features:

  • The Sontro Self-Fitting OTC Hearing Aids seamlessly connect via Bluetooth® to the otoTune® app, boasting a receiver in the canal (RIC) design, 16-channel wide dynamic range compression, noise reduction, feedback cancellation, automatic mode selection, and adaptive directionality. Users have the flexibility to effortlessly adjust volume, frequency tones, and listening modes. Backed by a 45-day Risk-Free guarantee, a 1-year warranty, and lifetime customer support, these hearing aids are eligible for FSA and HSA reimbursement. The otoTune technology is compatible with iOS and Android platforms. Importantly, the devices are user-adjustable, requiring no preprogramming or hearing test. Specifically designed for over-the-counter (OTC) sale and use without the involvement of a hearing care professional, they are competitively priced at $749 per set. Self-fitting OTC hearing aids target individuals aged 18 or older experiencing perceived mild to moderate hearing impairment.



Soundwave Hearing, LLC stands as a dedicated health tech company fervently championing the belief that optimal hearing health enhances lives. Rooted in the conviction that everyone should have access to top-tier hearing technology without the hindrances associated with traditional hearing aids, Soundwave Hearing, LLC is committed to breaking down barriers and making quality hearing solutions widely accessible.


Source: Soundwave Hearing LLC

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