MAUDE manufacturer profile
SIVANTOS, INC. · OSM
MAUDE profile for Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Key facts
| Manufacturer | SIVANTOS, INC. |
|---|---|
| Manufacturer group | SIVANTOS, INC. |
| Product code | OSM |
| Product code name | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Patient Device Interaction Problem, Overheating of Device, Ear infection, Material Deformation, Foreign Body In Patient, Appropriate Term/Code Not Available, Temperature Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1