Soundwave Hearing receives 510(k) clearance for Self-Fitting OTC Hearing Aids

Soundwave Hearing announced it received FDA 510(k) clearance for its Sontro Self-Fitting OTC Hearing Aids, which blend mobile technology and artificial intelligence calibration capabilities to self-fit and amplify sound for individuals aged 18 and older with mild to moderate perceived hearing impairment.

The Sontro hearing aids allow for personalization using AI technology to tailor the hearing experience to an individual’s needs without preconfigured settings. Each device is custom-programmed to match the user’s specific hearing requirements.

The hearing aids are used in tandem with the company’s otoTune app, which leverages a three-minute in situ hearing test administered while wearing the hearing aids to customize the self-fitting process. 

The hearing aids connect through Bluetooth to the otoTune app and include 16-channel wide dynamic range compression, noise reduction and feedback cancellation.

Another feature is what the company calls “Adaptive Directionality,” which enhances conversation clarity by using directional microphones to isolate speech in noisy environments.

The company collaborated with hearing health program Amptify DTx to offer Aural Rehabilitation, which includes a hearing health coach, listening games, an interactive curriculum and a support community.

“Our vision has always been clear: to break down the barriers to hearing care,” Anthony Florek, president and cofounder of Soundwave Hearing, said in a statement. “With the launch of the hearing aids, we are not just selling a product–we are offering a self-fitting technology defined for exactly one person at a time.”


According to the National Institute on Deafness and Other Communication Disorders, approximately 15% of adults in the U.S. report some trouble hearing. Individuals over the age of 65 are particularly impacted. 

Last year, the FDA established a new rule allowing the sale of over-the-counter hearing aids to individuals with mild-to-moderate hearing loss. 

Other companies offering tech-enabled hearing aids include TympaHealth, which offers a portable system that uses a smartphone for hearing health assessments, and Yes Hearing, which provides an online platform and at-home treatment for people who are hard of hearing.

In 2022, smart-hearing company Eargo released its sixth-generation hearing aids, which include a sound-adjust algorithm designed to change volume based on surrounding noise without the user manually adjusting the device. 

Eargo also announced a feature dubbed Mask Mode, aimed to help mitigate the challenges those with hearing loss face when speaking to someone wearing a mask.



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