Envoy Medical (COCH) investor relations material

Market opportunity and unmet need

• U.S. cochlear implant market estimated at $84 billion, with only 5% of eligible adults having received an implant, 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.

• Global hearing loss is projected to affect 2.5 billion people by 2050, with 700 million requiring rehabilitation.

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 offers discreet use, 24/7 hearing, up to five days between charges, and a replaceable battery designed for a 10-year lifespan.

• Utilizes proprietary sensor technology from the FDA-approved Esteem® device, de-risking core technology.

• Differentiates from competitors by avoiding subcutaneous microphones, magnets, and external processors, and supports use of in-ear consumer electronics.

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

• Seven leading U.S. cochlear implant centers participated in the pivotal trial, forming the backbone of the commercial launch.