Soundwave Hearing, LLC announces $510,000 FDA approval of over-the-counter self-fitting Sontro® hearing aids and award-winning otoTune® AI

Soundwave Hearing, LLC announces $510,000 FDA approval of over-the-counter self-fitting Sontro® hearing aids and award-winning otoTune® AI

Oak Brook, Illinois, November 06, 2023(BUSINESS WIRE)–Soundwave Hearing today announced $510,000 FDA approval for its Class II medical device, the self-fitting, over-the-counter Sontro® hearing aids, opening the door for Americans to access hearing aids. Affordable hearing aid. By combining the power of mobile phones with unique self-fitting AI technology, Soundwave Hearing creates personalized customization of Sontro self-fitting OTC hearing aids, eliminating common barriers to hearing aid access.

A recent study in The Lancet highlights hearing loss as the greatest modifiable risk for cognitive decline in older adults. Although 37.5 million Americans face hearing challenges, 80% of those who could benefit do not use hearing aids. Over-the-counter (OTC) hearing aids offer a promising and affordable solution, aiming to make hearing health accessible to everyone.

“The FDA’s 510k approval of Sontro self-fitting over-the-counter hearing aids is particularly timely, given regulations for over-the-counter hearing aids and the growing demand for telemedicine-based services. We are extremely proud “Our ability to create a custom, self-fitting device is a real milestone,” said Anthony Florrick, president and co-founder of Soundwave Hearing. “It is a leap forward in making hearing healthcare more accessible, patient-friendly, and ensuring a brighter cognitive future for many.”

What makes Sontro self-fitting OTC hearing aids different from other self-fitting OTC hearing aids?

Personal self-suitability: Uniquely, using revolutionary AI technology, Soundwave Hearing has developed a way for users to tailor it to their personal hearing needs. Soundwave does not use predefined settings. Each device is programmed to suit each user’s specific hearing requirements.

Unique state-of-the-art customization: Sontro OTC Self-Fitting Hearing Aids are the first OTC self-fitting hearing aids on the market to offer automatic mode selection and adaptive direction.

  • Why does this matter?

    • Auto Mode Select intelligently monitors the environment and automatically selects the most appropriate sound mode to help the user hear their best in every listening situation, allowing them to transition more smoothly from quiet to loud listening situations.

    • Adaptive directionality allows the user to easily follow a conversation by using directional microphones for better speech recognition in noisy environments (restaurants).

Hearing rehabilitation: Soundwave Hearing’s partnership with Amptify DTx is focused on consumer hearing health; It is one of the first over-the-counter hearing aids that offers auditory rehabilitation through the purchase of an over-the-counter hearing aid. Providing a hearing health coach, listening games, interactive curriculum and a support community. He learns more

Soundwave’s published research: Collaborative research study with top institutions, demonstrating that a patient-controlled hearing assessment using a hearing aid in a non-clinical setting is statistically comparable to an audiologist-controlled hearing assessment in a clinical setting. The focus of the study was Soundwave’s award-winning otoTune® application, which was used to perform patient-controlled hearing assessments in the study.

  • Resonance Medical, LLC and Soundwave Hearing, LLC provided funding for the research.

  • The article was published in Scientific Report, a respected and widely read scientific journal. Link to study

OTC Hearing Aid Features: Sontro self-fitting OTC hearing aids connect via Bluetooth® to the otoTune® app. Technology includes receiver-in-channel (RIC) design, 16-channel wide dynamic range compression, noise reduction and feedback cancellation, automatic mode selection, and adaptive orientation. Users can also easily adjust volume, frequency tones, and listening modes. Comes with a risk-free 45-day warranty, 1-year warranty, and lifetime customer support. Hearing aids are eligible for FSA and HSA reimbursements. otoTune is available on iOS and Android.

The devices are user-adjustable, and no prior programming or hearing testing is required. It is intended for over-the-counter (OTC) sale and for use without a hearing care professional and will be offered for sale $749/set. These self-fitting, over-the-counter sound amplification hearing aids were developed for individuals 18 years of age or older with mild to moderate hearing loss.


Soundwave Hearing, LLC is a health technology company deeply committed to the idea that good hearing health improves lives and believes everyone should have access to high-quality hearing technology without the barriers associated with traditional hearing aids.

Link to pictures:

otoTune® control screen

Beige and Gray Sontro® Self-Fitting Over-the-Counter Hearing Aids: Beige and Gray

View source version on


Susan Florrick, Vice President of Marketing
Email:, Phone: 708-207-7021, Website:

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