Esteem Active Middle Ear Implant by Envoy Medical: status and timeline

Milestones

No announced next step

FDA approval2010Complete.
Commercial availability in US2010Complete.
16 years of clinical data2026Complete.

Current obstacles

Limited surgeon trainingRequires otologic expertise. Few trained surgeons limits geographic access.

Physics limits

Ossicular integrityRequires intact or partially intact ossicles. Not suitable for complete ossicular loss.

How it works

4 parts

Microphone

External sound detection

Subcutaneous mic detects sound; wirelessly transmits signals to implanted processor.

Processing

Signal conversion

Implanted processor converts acoustic signals to mechanical vibrations for middle ear.

Vibration

Ossicular stimulation

Vibrating element stimulates middle ear bones, bypassing damaged inner ear hair cells.

Implantation

Surgical procedure

Single outpatient surgery; no external devices or daily insertion needed.

Spec sheet

Spec	Esteem Active Middle Ear Implant
Commercial availability	16+ years^R (reported)

^R reported by the company

About Envoy Medical

The team behind Esteem Active Middle Ear Implant

Envoy Medical

Fully implanted cochlear implant, Acclaim

Envoy Medical develops fully implanted hearing solutions. Esteem is FDA-approved for moderate-to-severe loss. Acclaim, the first fully implanted cochlear implant, is in pivotal trials.

Esteem is the only FDA-approved fully implanted hearing device (since 2010) for moderate-to-severe loss.
Acclaim, first fully implanted CI, completed pivotal trial enrollment in Apr 2026 with all 56 patients activated.
Acclaim received FDA Breakthrough Device Designation in 2020; PMA filing expected after 12-month follow-ups.

envoymedical.com (opens envoymedical.com)Company profile →

Founded: 199531 yrs
Headquarters: United States
Status: Public
Valuation: public
Works in: NeurotechCochlear implants
Coverage: 2 programs · 1 updatelatest 22 Apr 2026checked 11 Oct
Partners: FDA (opens fda.gov)
People: Brent Lucas (opens envoymedical.com)CEO