Envoy Medical (COCH) Investor presentation summary

Market opportunity and unmet need

• U.S. cochlear implant market estimated at $84 billion, with only 5% of eligible adults having received implants, leaving 95% untapped.

• Hearing loss affects 14% of Americans, with prevalence increasing with age; projected to impact over 73 million by 2060.

• Severe to profound hearing loss costs society about $297,000 per affected person over a lifetime.

• Detrimental effects include increased risk of dementia, falls, social isolation, depression, and higher healthcare spending.

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.

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

• Utilizes proprietary piezoelectric middle ear sensor technology, previously validated in the FDA-approved Esteem® device.

• No magnets or external microphones, supporting use of in-ear consumer electronics and designed for MRI compatibility.

Clinical and regulatory progress

• Acclaim® CI pivotal trial fully enrolled with 56 patients implanted and activated as of March 2026.

• Interim data show no serious adverse events and improved CNC word recognition from 15.2% to 39.2% at six months.

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

• FDA approval and commercial launch anticipated by end of 2027.