Data / Medical devices / Device, Assistive Listening
Device, Assistive Listening (LZI): 6 FDA-registered makers in 5 countries
6 establishments in 5 countries are registered with the FDA to make Device, Assistive Listening (product code LZI, Class 2, 21 CFR 874.3320). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on December 23, 2004, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LZI
- Device class
- 2
- Regulation
- 874.3320
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| China | 1 |
| Switzerland | 1 |
| Vietnam | 1 |
| Canada | 1 |
Makers of Device, Assistive Listening
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aha Technologies, Inc. | Detroit, MI, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonova AG | STAEFA Zurich, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonova Operations Center Vietnam Company Ltd | Ho Chi Minh City, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonova USA Inc. | Aurora, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unitron Hearing, a division of National Hearing Services Inc. | KITCHENER Ontario, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 23, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.