FDA device listing
Fortell AI Hearing Aids,Fortell Charging Case
FDA device listing 1856836202 · Fortell Research Inc.
Key facts
| Proprietary names | Fortell AI Hearing Aids,Fortell Charging Case |
|---|---|
| Owner/operator | Fortell Research Inc. |
| Owner/operator number | 10094317 |
| Product codes | OSM |
| Device names | OSM - Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | FORTELL RESEARCH INC., Fortell Research Manufacturing |
| Establishment registrations | 3041897366, 3042472334 |
| FEI numbers | 3041897366, 3042472334 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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