Sonova
Medical device makerAI in SwitzerlandAI. FDA records under its name, each linked to the record.
- Records across the group: 135, 7 entitiesAI
- 510(k) clearances: 121
- Device recalls: 14
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sonova and its 6 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Apr 11, 2024 | Lyric4 Hearing AidK232999 · ESD | 510(k) clearances |
| Jun 16, 2023 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidK230538 · QUH | 510(k) clearances |
| Jun 27, 2013 | LYRIC2K130790 · ESD | 510(k) clearances |
| May 7, 2013 | UNITRON TINNITUS MASKER FEATUREK130494 · KLW | 510(k) clearances |
| Feb 11, 2013 | PHONAK TINNITUS BALANCEK123450 · KLW | 510(k) clearances |
| Sep 14, 2007 | HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to proClass II · Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting i | Device recalls |
| Oct 28, 1998 | MAICO MA42K982723 · EWO | 510(k) clearances |
| Apr 22, 1998 | MAICO MA53K981142 · EWO | 510(k) clearances |
| Dec 15, 1997 | OPUS 2 - CANAL SERIES (ITC)K974069 · ESD | 510(k) clearances |
Subsidiaries and Divisions
6 firms in the Sonova group, most records first- Unitron Industries69 records
- Phonak39 records
- Advanced Bionics14 records
- Bernafon-Maico9 records
- Unitron1 records
- Unitron Hearing1 records
Canada and Imports
Across the Sonova group, matched by company nameNames and Identifiers
- Appears as
- Website
- sonova.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built