Details checkedStrong evidenceCheckedregulatory

Envoy Medical Esteem Fully Implanted Hearing System

Also known as: Esteem, Esteem Totally Implantable Hearing System, FI-AMEI

Envoy Medical

Primary source

Company

Envoy Medical

Program Type

Device

Modality

Active Middle Ear Implant

Stage

Marketed

Status

Marketed

Target Gene

—

Route / Mode

Fully implantable middle-ear device

Confidence

97%

Status Confidence

Status confirmed

Evidence Strength

Strong evidence

Last Reviewed

2026-06-10

Geography

United States, selected global markets

Population

adult, moderate-severe, post-lingual, active-middle-ear-implant, fully-implantable-hearing-device

Trial IDs

Mechanism

A totally implanted active middle-ear hearing system that uses the ear's natural anatomy and an internal electromechanical transducer without an external processor.

Indications

Hearing Loss Sensorineural Hearing Loss

Notes

The only FDA-approved fully implanted active middle-ear hearing device and therefore strategically significant despite a smaller commercial footprint than mainstream hearing aids. Classified under bone-conduction/middle-ear taxonomy because Esteem is an active middle-ear implant, not a cochlear implant.

Evidence & Sources

3 structured sources

company

Supports: canonicalName, aliases, company, mechanism, indications, status, route

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regulatory

Supports: stage, status, populationTags, notes, keyEvents

IDs: P090018

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company

Supports: notes, status

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