Envoy Medical (COCH) Investor presentation summary

Market opportunity and unmet need

• U.S. cochlear implant market estimated at $84 billion, with 2.8 million adults as candidates and only 5% currently treated, leaving 95% of the market untapped.

• Hearing loss affects 14% of Americans, with prevalence increasing with age; by 2060, over 73 million Americans are expected to have hearing loss.

• Severe to profound hearing loss costs society about $297,000 per affected person over a lifetime and is linked to increased dementia risk, falls, depression, and reduced income.

• The cochlear implant market is expected to grow due to an aging population, expanding candidacy, and rising awareness.

Product innovation and differentiation

• Acclaim® CI is the first fully implanted cochlear implant, eliminating the need for external hardware and leveraging the natural ear pathway for sound.

• Device features include no visible hardware, proprietary sensor, five-day recharge interval, and MRI compatibility (pending testing).

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

• Differentiation includes a replaceable battery, no magnets, and support for in-ear consumer electronics, unlike competitors using subcutaneous microphones and smaller, non-replaceable batteries.

Clinical and regulatory progress

• Acclaim® CI pivotal trial fully enrolled with 56 patients implanted and activated as of March 2026; first in the industry to achieve this milestone.

• Interim six-month data showed no serious adverse events and improved CNC word recognition from 15.2% to 39.2%.

• FDA Breakthrough Device Designation granted in 2019; pivotal trial sites include leading U.S. cochlear implant centers.

• FDA approval and commercial launch anticipated by end of 2027, with PMA submission expected in Q2 2027.