Envoy Medical Reports Positive 12-Month Data Showing Continued Improvement in Speech Perception in Study of First-of-Its-Kind Fully Implanted Cochlear Implant

Mean CNC word recognition scores for Stage 1 cohort improved to 53.2% at 12 months from 15.2% pre-implantation, a 38.0 percentage point gain that continued to build on the 24.0 percentage point improvement reported at 6 months

White Bear Lake, Minnesota--(Newsfile Corp. - July 14, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced positive 12-month data from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant.

The Stage 1 cohort demonstrated a mean Consonant-Nucleus-Consonant ("CNC") word recognition score of 53.2% at their 12-month visits, up from a mean pre-implantation baseline of 15.2% — a 38.0 percentage point improvement. This represents continued improvement over the 39.2% mean score (a 24.0 percentage point improvement from baseline) previously reported by the Company at the 6-month visits for the Stage 1 cohort. The primary efficacy endpoint for the Acclaim® cochlear implant pivotal clinical study will be assessed on 12-month data.

"We hope that our shareholders and investors are as encouraged as we are by the updated data readout from the first 10 participants in Stage 1 of the Acclaim® clinical study," said Brent Lucas, Chief Executive Officer of Envoy Medical. "While we believed the six-month data readout from Stage 1 was promising, we reasonably expected to see meaningful continued improvement through 12 months and are seeing objective evidence supporting that belief. While the study remains ongoing and these interim results are preliminary, these data reinforce our conviction that the future of cochlear implants is in fully implanted devices using Invisible Hearing® technology."

12-Month Data Highlights (Specific to 10 Participants in Stage 1)

• CNC word recognition: mean scores continued to improve through the 12-month visits, increasing to 53.2% from a pre-implantation baseline of 15.2% — a 38.0 percentage point improvement. This improvement compares to a 39.2% mean score and 24.0 percentage point improvement reported after the 6-month visits.
  • Of the 10 participants in the Stage 1 cohort, nine demonstrated a positive hearing response consistent with the overall trend, while one patient has been identified as a potential "non-responder." The Company is actively reviewing the underlying cause of this patient's outcome.
  • In a supplementary analysis of 12-month visit data excluding this patient, the mean CNC word recognition score among the remaining nine responders was 59.1%, a 42.2 percentage point improvement from baseline, compared to the 53.2% mean score and 38.0 percentage point improvement reported across all 10 participants.
• Safety: Among the first 10 participants in Stage 1 of the pivotal trial through their 12-month visits, no serious adverse events ("SAEs") as defined by the study protocol were reported.
• Other data including AzBio sentence scores, quality of life questionnaires, and other patient-reported outcome measures are being collected as part of the overall study protocol but are not part of this top-line data readout. Full data will be included as part of the Company's overall Premarket Approval ("PMA") submission to the United States Food and Drug Administration ("FDA").

This 12-month data marks the completion of primary endpoint follow-up for Stage 1 of the Company's two-stage pivotal clinical trial. Following FDA approval to expand the trial, Envoy Medical advanced to Stage 2, the final stage of the pivotal trial, which is now fully enrolled.

All Stage 2 participants have completed their 1-month visit with many having progressed through their 3- and 6-month follow-up visits. The Company expects all Stage 2 participants to complete their 12-month data collection by early Q2 2027, with a PMA submission to the FDA planned to follow a few months thereafter.

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It is important to note that approval of an Investigational Device Exemption ("IDE") application, the expansion of an IDE pivotal clinical trial, or these data points for the first 10 participants does not ensure that the results of the investigation will ultimately provide a reasonable assurance of the safety and effectiveness of the device or assure a determination of approval of a premarket submission.

About Envoy Medical, Inc.

Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.

About the Fully Implanted Acclaim® Cochlear Implant

We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.

The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.

The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.

CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.

About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)

The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.

*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.

Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.

Additional Information and Where to Find It

Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.

See Important Information here.