Esteem Totally Implantable Hearing System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM FDA PMA
- Generic Name
- Implant, hearing, active, middle ear, totally implanted FDA PMA
Identifiers
- PMA Number
- P090018 FDA PMA
- FDA Product Code
- OAF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ear, Nose, Throat FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Esteem Totally Implantable Hearing System is an active middle ear implant designed to alleviate hearing loss by replicating the ossicular chain and providing additional gain. This totally implanted device is intended for adults with stable bilateral sensorineural hearing loss who meet specific criteria including age, hearing thresholds, speech discrimination scores, and normal middle ear anatomy.
The Esteem implant is surgically placed in the middle ear and requires adequate space as determined by high-resolution CT scan. It is intended for patients with at least 30 days of experience with appropriately fitted hearing aids and normally functioning Eustachian tubes. The device received FDA PMA approval in 2010 and is manufactured by Envoy Medical Corporation in White Bear Lake, Minnesota.
Frequently asked questions
What is the Esteem Totally Implantable Hearing System?
The Esteem is an active middle ear implant that alleviates moderate to severe sensorineural hearing loss in adults by replicating the ossicular chain and providing additional gain. It is a totally implanted device that surgically placed in the middle ear, unlike traditional hearing aids that sit outside the ear.
Who is a candidate for the Esteem implant?
Candidates must be 18 years or older with stable bilateral sensorineural hearing loss defined by specific pure tone averages and speech discrimination scores. They must have normally functioning Eustachian tubes, normal middle ear anatomy and tympanic membrane, and adequate space for the implant as determined by CT scan. Additionally, candidates must have at least 30 days of experience with appropriately fitted hearing aids.
How does the Esteem implant differ from traditional hearing aids?
Unlike traditional hearing aids that amplify sound and sit outside the ear, the Esteem is surgically implanted in the middle ear and works by directly stimulating the ossicular chain. It is designed to provide more natural sound quality and is completely hidden, with no external components visible.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P090018 | Class III | Active |
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Manufacturer
- Manufacturer
- Envoy Medical Corporation
Sources (1)
- FDA PMA P090018 24 fields · synced Sep 18, 2026