FDA device listing
Go Ultra OTC Hearing Aids,Lexie H1 OTC Hearing Buds
FDA device listing 1094265915 · hearX
Key facts
| Proprietary names | Go Ultra OTC Hearing Aids,Lexie H1 OTC Hearing Buds |
|---|---|
| Owner/operator | hearX |
| Owner/operator number | 10057906 |
| Product codes | QUG |
| Device names | QUG - Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | HEARX SA, hearX USA |
| Establishment registrations | 3014337591, 3015246392 |
| FEI numbers | 3014337591, 3015246392 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database