Envoy Medical (COCH) investor relations material

Investment highlights and product design

• Acclaim CI is an investigational, fully implanted cochlear implant designed to pick up sound through the natural ear pathway, with no external processor or visible head hardware.

• Differentiators include a piezoelectric middle-ear sensor, a larger-capacity chest battery, no magnets, and compatibility with in-ear consumer electronics; MRI compatibility remains untested.

• The rechargeable battery is expected to last several days between charges; presentation estimates average charging every 4+ days based on initial data.

• Acclaim CI uses sensor technology from the FDA-approved Esteem implant, which has been implanted in ~1,000 patients at ~20 sites globally.

• The existing CI market is estimated at ~$2B annual sales, based on an assumption of ~77,000 units sold in 2025 at a $25,000 ASP.

Market opportunity

• Estimated U.S. CI candidate population is ~2.8M adults; only ~5% of adults who could benefit have received an implant, leaving 95% of the adult market untapped.

• Estimated U.S. TAM is $84B; if approved, Acclaim CI pricing is anticipated at ~$30K versus ~$25K for current U.S. implants.

• Market growth drivers include an aging population, expanding candidacy, increasing awareness, and bilateral implantation by ~30% of adult patients.

• U.S. clinically relevant hearing loss affects 14% of Americans; the population with hearing loss is projected to rise from 44M in 2020 to over 73M by 2060.

Clinical and regulatory progress

• Pivotal trial enrollment completed March 11, 2026, with all 56 patients implanted and activated across seven sites; the first three patients reached the 12-month endpoint.

• May 2026 interim six-month data showed no serious adverse events and CNC word recognition improvement from 15.2% to 39.2%.

• The primary effectiveness endpoint compares each patient's 12-month CNC word score with their pre-operative aided score; patients serve as their own control.

• All 56 patients are expected to complete 12-month follow-up in Q1 2027; PMA submission is expected in Q2 2027, with an FDA decision and launch anticipated in 2027.

• Acclaim CI received FDA Breakthrough Device Designation in 2019 and an IDE for its pivotal clinical study; use is limited to investigational purposes.