PMA
P090018: ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
FDA PMA · Implant, hearing, active, middle ear, totally implanted · Envoy Medical Corporation
Key facts
| PMA number | P090018 |
|---|---|
| Trade name | ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM |
| Generic name | Implant, hearing, active, middle ear, totally implanted |
| Applicant | Envoy Medical Corporation |
| Owner/operator | ENVOY MEDICAL CORPORATION |
| Product code | OAF |
| Approval date | Mar 17, 2010 |
| Docket number | 10M-0244 |
| Notice date | May 20, 2010 |
| Establishment registration | 3004007782 |
| FEI number | 3004007782 |
At a glance
- 10–99 Supplements
- Jun 3, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: