Data / Medical devices / Face Plate Hearing Aid
Face Plate Hearing Aid (LRB): 20 FDA-registered makers in 6 countries
20 establishments in 6 countries are registered with the FDA to make Face Plate Hearing Aid (product code LRB, Class 1, 21 CFR 874.3300). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on February 20, 1998, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LRB
- Device class
- 1
- Regulation
- 874.3300
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| China | 11 |
| United States | 3 |
| Denmark | 2 |
| Malaysia | 2 |
| Poland | 1 |
| Mexico | 1 |
Makers of Face Plate Hearing Aid
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 |
|---|---|---|---|---|---|---|---|---|
| Audina Hearing Instrument, Inc | Longwood, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Austar Hearing Science & Technology (xiamen) Co., Ltd | Xiamen City Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demant Operations Poland Sp. z o.o. | Mierzyn Zachodniopomorskie, Poland | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demant Operations, S.a. De C.v. | Tijuana Baja California, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Hearing A/S | BALLERUP Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Resound China, Ltd. | XIAMEN Fujian, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN ReSound (Malaysia) Sdn Bhd. | Kulai Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN ReSound (Malaysia) Sdn. Bhd | Senai Johor, Malaysia | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magnatone Hearing Aid Corp. dba Persona Medical | Casselberry, FL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oticon A/S | Smorum Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Byring Hearing Technology Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Zhongde Audio-Technical Co., Ltd. | Shenzhen City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Melosound Technology Co.,ltd | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Newsound Technology Co., Ltd | Xiamen Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Realink Hearing Technology Co., Ltd | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Retone Hearing Technology Co., Ltd. | Xiamen Fujian, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Vienatone Medical Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Xin Hongsheng Technology Co.,ltd | Zhongshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 20, 1998. 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.