Soundwave Hearing has received 510k clearance from the US Food and Drug Administration (FDA) for Sontro Self-Fitting over the counter (OTC) Hearing Aids and the artificial intelligence (AI)-based otoTune app.

Sontro Self-Fitting OTC Hearing Aids is a Class II Medical Device that is said to combine the power of mobile phones and self-fitting AI technology to offer affordable hearing aids.

Soundwave Hearing has created custom personalisation for its hearing aids to eliminate common barriers to accessing hearing aids. Every device is set to each user’s particular hearing needs, said the US-based health tech company.

The Sontro hearing aids and otoTune app use a three-minute in situ hearing test to customise the self-fitting process.

The patented otoTune app simultaneously analyses both ears to provide clinically validated test results and customisation to meet each user’s hearing and listening needs, the health tech company said.

The hearing aids are said to be the first on the market to provide both adaptive directionality and automatic mode selection.

Soundwave Hearing president and co-founder Anthony Florek said: “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.

“We are extremely proud of our ability to create a personalised, 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.”

The otoTune app and the Sontro Self-Fitting OTC Hearing Aids are designed to connect via Bluetooth.

Additional technology include feedback cancellation and noise reduction, automatic mode selection, adaptive directionality, 16-channel wide dynamic range compression, and receiver in the canal (RIC) architecture.

Furthermore, volume, frequency tones, and listening modes are easily adjustable by users. The otoTune technology is available on iOS as well as on Android.

According to Soundwave Hearing, users can modify the hearing device without the need for preprogramming or hearing tests.

They will be available for $749 a set and are meant to be purchased OTC and used without the assistance of a hearing care professional.

The hearing aids device is suitable for people who have mild to moderate hearing impairment and are at least 18 years old, the health tech firm added.