# Shenzhen Flysounds Medical Technology Co., Ltd. (foreign exporter, Shenzhen Guangdong, CN): 1 new FDA device listing, incl. hearing aid, air-conduction with wireless technology, prescription

**Score:** 40/100

| Field | Value |
|---|---|
| Establishment | Shenzhen Flysounds Medical Technology Co., Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 1 |
| Devices | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Product codes | OSM |
| Device classes | Class II |
| Medical specialties | Ear, Nose, Throat |
| Brand names | Hearing aids with models PO1 PO2 PO3 PO4 PO5 PO6 PO7 PO8 PO9 PO10; Hearing aids with models PB1 PB2 PB3 PB4 PB5 PB6 PB7 PB8 PB9 PB10; Hearing aids with models PC1 PC2 PC3 PC4 PC5 PC6 PC7 PC8 PC9 PC10; Hearing aids with models PH1 PH2 PH3 PH4 PH5 PH6 PH7 PH8 PH9 PH10 PH11 PH12 PH13 PH14 PH15 PH16 PH17 PH18 PH19 PH20; Hearing aids with models PR1 PR2 PR3 PR4 PR5 PR6 PR7 PR8 PR9 PR10 PR11 PR12 PR13 PR14 PR15 PR16 PR17 PR18 |
| First new listing | 2026-08-12 |
| Latest new listing | 2026-08-12 |
| FDA registration number | 3034733579 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.