Soundwave Hearing Announces 510K Clearance for
Sontro Self-Fitting OTC Hearing Aids
Oak Brook, IL, November 3, 2023 - Soundwave Hearing today announced 510k FDA clearance for its Class II Medical Device, Sontro® Self-Fitting OTC Hearing Aids, opening the door for Americans to 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. For adults 18 years or older with perceived mild-to-moderate hearing loss.
Soundwave's Published Research
A collaborative research study with top institutions established that a patient-controlled hearing assessment with a hearing aid in a non-clinical setting is statistically comparable to an audiologist-controlled hearing assessment in a clinical environment. Central to the study was Soundwave’s award-winning otoTune® app, which was used to perform patient-controlled hearing assessments in the study.
The Personal Difference
Personalized Self-Fit: Uniquely, using revolutionary 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.
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The Sontro Self-Fitting OTC Hearing Aids and otoTune® app use a 3-minute in situ hearing test to customize the self-fitting process (in situ: a hearing test is administered while wearing the devices, paired to the app).
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The patented 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 Customization
State-of-the-Art Customization: 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 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 move more seamlessly from quiet to noisy listening situations.
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Adaptive Directionality allows the user to follow a conversation easily by using directional microphones to better identify speech in noisy environments (restaurants).
With Sontro® Self-Fitting OTC Hearing Aids,
one size fits exactly one.
Sontro Self Fitting OTC Hearing Aids are available now!