Medical Device Manufacturer · US , Oak Brook , IL

Soundwave Hearing, LLC - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2023

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Soundwave Hearing, LLC Ear, Nose, Throat ✕

1 devices

1-1 of 1

Cleared Oct 26, 2023

Sontro® OTC Hearing Aids (AI)

Ear, Nose, Throat · 149d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 16, 2026