Envoy Medical, Inc. (NASDAQ: COCH) saw its shares rallying on the US stock charts, building on the previous day’s momentum. In the pre-market session, COCH stock traded 6.79% higher at $2.83, following a 7.29% rise the day prior. This upward trend reflects growing investor interest, fueled by the company’s latest milestone: U.S. FDA approval of its Investigational Device Exemption (IDE) for the Acclaim Fully Implanted Cochlear Implant pivotal study.
Acclaim Device: A New Approach to Hearing Loss
The Acclaim Fully Implanted Cochlear Implant stands out from conventional hearing implants, utilizing an implanted sensor to capture sound based on the natural ear anatomy. With FDA approval, Envoy Medical now moves forward in researching the device’s effectiveness for individuals with severe to profound hearing loss.
Currently, approximately 95% of patients who might benefit from cochlear implants do not receive them, often due to limitations with traditional devices. Envoy believes Acclaim’s unique design could encourage broader acceptance and bring more people the benefits of advanced hearing technology.
Selecting Top U.S. Institutions for Pivotal Study
Envoy Medical plans to partner with leading cochlear implant centers across the U.S. for the Acclaim pivotal study. As Institutional Review Board (IRB) approvals come through, Envoy will reveal participating sites, inviting interested patients to join. The company is energized by the enthusiastic response from top-tier medical programs, though only a select number of institutions will be involved in this initial phase.
Progress in the Hearing Industry
FDA approval marks an essential step in advancing Acclaim towards commercial availability. The study will progress in stages, with preliminary data collected from a subset of patients before full enrollment. While IDE approval does not guarantee final market clearance, Envoy’s achievement signals progress for the hearing industry.
This accomplishment follows the American Medical Association’s recent approval of CPT codes for fully implantable active middle ear devices, further strengthening Envoy’s position with its FDA-approved Esteem device and, potentially, its investigational Acclaim technology. Together, these advancements hold promise for expanding treatment options for hearing loss patients.