FDA device listing
Accent,America Hears,Aspire,Assure,Capsure,Ear Back Hearing Aid Model 246,Ear Back Hearing Aid Model 256,Ear Back…
FDA device listing 1308650498 · Hearing Lab Technology, LLC
Key facts
| Proprietary names | Accent,America Hears,Aspire,Assure,Capsure,Ear Back Hearing Aid Model 246,Ear Back Hearing Aid Model 256,Ear Back Hearing Aid Model 446,Ear Back Hearing Aid Model 456,Ear Back Hearing Aid Model 546,Ear Back Hearing Aid Model 556,Ear Back Hearing Aid Model 557,Ear Back Hearing Aid Model 746,Ear Back Hearing Aid Model 756,Elevate,Engage,Freedom,Liberty,Liberty Engage,Member's… |
|---|---|
| Owner/operator | Hearing Lab Technology, LLC |
| Owner/operator number | 10052054 |
| 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 | HEARING LAB TECHNOLOGY, LLC |
| Establishment registrations | 3012213704 |
| FEI numbers | 3012213704 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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