Tag: FDA 510(k)

Soundwave Hearing announced 510(k) FDA clearance for its Sontro Self-Fitting OTC Hearing Aids designed to help Americans access affordable hearing aids. By combining the power of mobile phones and unique self-fitting AI technology, Soundwave Hearing has created custom personalization for its Sontro Self-Fitting OTC Hearing Aids, removing common barriers to accessing hearing aids, the company says. A recent study in The Lancet highlights hearing loss as the top modifiable risk for cognitive decline in older adults. Despite 37.5 million Americans facing hearing challenges, 80% who could benefit don't use hearing aids. Over-the-counter (OTC) hearing aids offer a promising and affordable solution, aiming to make hearing health accessible for all. “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,” says Anthony Florek, president and co-founder of Soundwave Hearing. “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 Self-Fitting OTC Hearing Aids Using AI technology, Soundwave Hearing has developed a method for users to self-fit their personal hearing needs. Soundwave does not use predetermined settings. Every device is programmed to each user’s specific hearing requirements. The Sontro Self-Fitting OTC Hearing Aids connect via Bluetooth to the otoTune app. Technology includes receiver in the canal (RIC) design, 16-channel wide dynamic range compression, noise reduction and feedback cancellation, automatic mode selection, and adaptive directionality. Users can also effortlessly adjust volume, frequency tones, and listening modes. The hearing aids are eligible for FSA and HSA reimbursement, and the otoTune technology is available on iOS and Android. The Sontro Self-Fitting OTC Hearing Aids, in tandem with the otoTune app, uses a three-minute in situ hearing test to customize the self-fitting process. The otoTune app tests both ears simultaneously using the devices, delivering clinically validated test results and programming to the user’s unique hearing and listening needs. The Sontro hearing aids also feature Automatic Mode Selection and Adaptive Directionality. The devices are adjusted by the user, and no preprogramming or hearing test is necessary. Photo: Soundwave Hearing

Tag: FDA 510(k)

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