Sonova AG - FDA 510(k) Cleared Devices

Sonova AG, is a global hearing healthcare company headquartered in Zurich, Switzerland. The company designs and manufactures hearing aids and cochlear implant systems for patients with hearing loss.

Sonova has received 2 FDA 510(k) clearances from 2 total submissions. The company specializes in Ear, Nose, Throat devices, which represent 100% of its FDA submissions. Recent cleared devices include the Lyric4 Hearing Aid and the All-Day Clear series. First clearance: 2023. Latest clearance: 2024. The company remains active in FDA regulatory submissions.

Sonova operates a diverse portfolio of hearing aid brands and cochlear implant solutions through its retail and wholesale channels worldwide. The company serves patients across multiple continents through established distribution networks and specialized hearing care centers.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Hymann, Phelps, & Mcnamara P.C. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.