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FDA PMA

Implant, hearing, active, middle ear, totally implanted

PMA Number: P090018 · 2026-06-03

ApplicantEnvoy Medical Corporation
Decision Date2026-06-03
PMA NumberP090018
Product CodeOAF
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeEN

Device Summary

Implant, hearing, active, middle ear, totally implanted is the device name listed in this FDA 510(k) record. The listed applicant is Envoy Medical Corporation. It received FDA 510(k) clearance on 2026-06-03. The device is classified under product code OAF. It was reviewed by the EN advisory panel.

Frequently Asked Questions

What is the Implant, hearing, active, middle ear, totally implanted?

Implant, hearing, active, middle ear, totally implanted is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Envoy Medical Corporation.

When did Implant, hearing, active, middle ear, totally implanted receive FDA 510(k) clearance?

The clearance date for Implant, hearing, active, middle ear, totally implanted can be found in the official FDA records.

Who is the listed applicant for Implant, hearing, active, middle ear, totally implanted?

The FDA 510(k) record lists Envoy Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implant, hearing, active, middle ear, totally implanted?

The FDA product code for Implant, hearing, active, middle ear, totally implanted is OAF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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