TL;DR
Turn quiet afternoons into listening time
- Thousands of audiobooks, podcasts and originals
- Listen on your phone, tablet or Echo — also offline
- Cancel anytime
Envoy Medical reported third-quarter 2026 financial results and clinical progress for its investigational Acclaim cochlear implant. After the quarter ended, all 56 pivotal-trial participants had passed the six-month follow-up milestone, and the company submitted a second module of its FDA application. The trial’s primary efficacy assessment depends on 12-month data, which the company expects to collect from all participants by early Q2 2027.
Envoy Medical reported its third-quarter 2026 financial results on Nov. 5 and said its pivotal trial of the investigational Acclaim cochlear implant reached six-month follow-up for all 56 participants after the quarter ended. The company also submitted a second module of its application to the U.S. Food and Drug Administration, as the trial moves toward its primary evaluation based on 12-month data.
During the quarter, Envoy reported 12-month results for the first 10 participants in Stage 1 of the pivotal study. The company said their mean Consonant-Nucleus-Consonant (CNC) word recognition score was 53.2%, compared with a pre-implant baseline of 15.2%. That is a reported improvement of 38.0 percentage points. The company also said the improvement had grown from 24.0 percentage points at six months. These results cover the first 10 participants, not the full trial cohort.
After quarter-end, all 56 participants passed the six-month follow-up milestone, according to Envoy. The full cohort had already passed the three-month follow-up window during Q3. The company says the trial’s primary efficacy endpoint will be evaluated using 12-month data; six-month follow-up is an interim milestone and does not establish the primary outcome. Envoy expects all Stage 2 participants to complete 12-month data collection by early in the second quarter of 2027.
Envoy said it submitted the second of four planned modules in its modular Premarket Approval application to the FDA after the quarter closed. The first module was submitted in Q2 2026, and the company expects the final module to contain final clinical trial data. It plans to submit that final module a few months after the remaining 12-month data are collected. The Acclaim device has FDA Breakthrough Device Designation, but remains investigational and is limited by federal law to investigational use.
For Q3, net revenue was $66,000, compared with $42,000 in the same quarter of 2025. Research and development expenses rose to $3.1 million from $2.7 million, which the company attributed largely to increased clinical follow-up and trial and regulatory support. Sales and marketing expenses fell to $157,000 from $405,000, mainly because field clinical specialists were reassigned to research and development activities. General and administrative expenses were $2.1 million, up from $2.0 million.
Envoy reported a net loss attributable to common stockholders of $5.2 million, or $0.50 per basic and diluted share, compared with a $7.7 million loss, or $3.55 per share, in Q3 2025. The company had approximately $14.6 million in cash as of Sept. 30, 2026. Separately, it said a lawsuit brought by Atlas Merchant Capital SPAC Fund I LP was dismissed with prejudice under an Oct. 6 agreement, with no payment by Envoy or the other defendants.
The Trial’s 12-Month Test
The update puts the focus on whether the Acclaim system can meet its clinical endpoint and, eventually, gain FDA approval. Six-month follow-up across all 56 participants marks progress in data collection, while the reported 12-month results from the first 10 provide an early view of performance. They are not a substitute for the full trial’s primary analysis, which depends on the later data.
The device is designed to be fully implanted and capture sound using the ear’s natural anatomy rather than an external microphone. If supported by trial results and authorized by regulators, that design could offer a different option for some adults with severe to profound sensorineural hearing loss. For now, the device remains investigational; the company’s reported financial results also show ongoing clinical-development costs alongside limited quarterly revenue.
Popular right now
Breville Bambino Espresso Machine, Brushed Stainless Steel
Vitamix Touch & Go Advance 32-Ounce Bar Blender, White
Breville Barista Express Espresso Machine with Built-In Grinder, Black Sesame
As an affiliate, we earn on qualifying purchases.
From First Filing to Final Data
Envoy Medical, based in White Bear Lake, Minnesota, is developing Acclaim for adults with severe to profound sensorineural hearing loss not adequately addressed by hearing aids. The company describes it as a fully implanted cochlear implant that uses the natural anatomy of the ear to capture sound. FDA Breakthrough Device Designation applies to the investigational device but is not approval to market it.
Envoy submitted the first module of its modular PMA application in Q2 2026. Its latest update adds a second module and reports progress in follow-up for the pivotal trial, which completed enrollment in Q1 2026. The company also said Canadian and Hong Kong patents granted during Q3 brought its portfolio to 97 granted patents—40 in the United States and 57 abroad—with 35 applications pending. Envoy separately markets the Esteem fully implanted active middle ear implant, which the source says has been FDA-approved for adults with moderate to severe sensorineural hearing loss since 2010.
“We remain on track for all participants to complete their 12-month visits by early in the second quarter of 2027.”
— Brent Lucas, Envoy Medical chief executive officer, in a company release
Full Trial Results Still Pending
The available efficacy figures cover only the first 10 Stage 1 participants. The source material does not provide full-cohort 12-month results, a complete account of trial safety findings, or the final analysis of the primary endpoint. Until those data are collected and evaluated, the results cannot establish whether the device will meet the study’s primary efficacy measure.
The FDA has not approved Acclaim for commercial use. The timing and outcome of the agency’s review remain unknown, including whether it will request additional information after receiving the planned final application module. Envoy’s stated submission schedule is a company expectation, not a regulatory decision.
Remaining Visits and FDA Filing
Envoy expects all Stage 2 participants to complete their 12-month visits by early Q2 2027. The company says it plans to submit the fourth and final PMA module, containing final clinical trial data, a few months after that collection is complete. The next key information will be the full trial results and the FDA’s response to the completed submission.
Until then, Acclaim remains limited to investigational use. The company’s Q3 update does not state a date for a potential FDA decision or provide a forecast for commercialization.
Key Questions
What did Envoy Medical report about the Acclaim trial?
Envoy said all 56 participants had passed the six-month follow-up milestone after Q3 ended. During the quarter, it reported 12-month CNC word recognition results for the first 10 Stage 1 participants.
What were the reported 12-month results for the first 10 participants?
The company reported a mean CNC word recognition score of 53.2%, compared with a pre-implant baseline of 15.2%. Envoy described this as a 38.0 percentage-point improvement. The figures are for the first 10 participants, not the full cohort.
Is the Acclaim cochlear implant FDA-approved?
No. The device has Breakthrough Device Designation, but remains investigational and is limited by federal law to investigational use. That designation is not marketing approval.
When does Envoy expect to complete 12-month follow-up?
Envoy expects all Stage 2 participants to complete their 12-month data collection by early in the second quarter of 2027. The company plans to submit its final PMA module a few months afterward.
How much cash did Envoy report at the end of Q3?
Envoy reported approximately $14.6 million in cash as of Sept. 30, 2026. Its Q3 net loss attributable to common stockholders was $5.2 million.
Source: hearingreview.com
