# P090018: Esteem Totally Implantable Hearing System

- Pathway: PMA
- Applicant: Envoy Medical Corporation
- Decided: Mar 17, 2010 after 225 days
- Product code: OAF (Implant, Hearing, Active, Middle Ear, Totally Implanted)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 28, 2018 · Class II · Z-2590-2018: Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled
- Jan 9, 2013 · Class II · Z-0750-2013: Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interferenc

Source page: https://510kreport.com/device/P090018
Methodology: https://510kreport.com/methodology