Acclaim Cochlear Implant by Envoy Medical: status and timeline

Acclaim Cochlear Implant

Provide fully invisible, battery-free cochlear implant restoring hearing to patients with severe-to-profound loss.

PilotStage 3 of 5

Enrollment complete (56 patients, Mar 2026). All activated Apr 2026. 12-month follow-ups underway.

Updated 22 Apr 2026Checked 11 Oct0 updates this week

Milestones

Next · 12-month follow-up completion

FDA Breakthrough Device Designation29 Jun 2020Complete.
Pivotal trial enrollment complete11 Mar 2026Complete.
All 56 patients activated22 Apr 2026Complete.
12-month follow-up completionTarget 2027Current milestone.
FDA PMA filingTarget 2027Not yet reached.

Most important updates

Envoy Medical completes activation of all 56 patients in pivotal Acclaim cochlear implant trial22 Apr 2026

Upcoming

202712-month follow-up completion (next)
2027FDA PMA filing

Current obstacles

Surgical expertise neededAcclaim requires specialized otologic training. Building network of capable surgical centers is critical.
Reimbursement pathwayInsurance coverage for experimental implants is uncertain. Establishing reimbursement requires long-term efficacy data.

Physics limits

Anatomic variationMiddle ear size and structure vary, requiring surgical customization for proper implant positioning.
Sensor fidelitySensor-based detection may not capture full hearing range of external microphones.

How it works

4 parts

Sensor placement

Implanted audio sensor

Surgically implanted in middle ear; detects vibrations from eardrum rather than using external microphone.

Sound detection

Natural ear anatomy

Sensor leverages ear's natural anatomy to detect vibrations, bypassing external sound conversion.

Stimulation

Direct nerve stimulation

Implanted processor converts vibrations to electrical signals; directly stimulates cochlear nerve.

Invisibility

Fully internal

All components implanted; provides 24/7 hearing without visible devices or daily insertion.

Spec sheet

Spec	Acclaim Cochlear Implant
Pivotal trial patients	56^R (reported)
FDA designation	Breakthrough Device^R (reported)

^R reported by the company

Update log

1 update

Wed 22 Apr

Major: Envoy Medical completes activation of all 56 patients in pivotal Acclaim cochlear implant trialPressTest

About Envoy Medical

The team behind Acclaim Cochlear 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

Spec

Acclaim Cochlear Implant

Pivotal trial patients

56^R (reported)

FDA designation

Breakthrough Device^R (reported)