Summary:
Envoy Medical Inc. has successfully enrolled the first two participants in its pivotal clinical study for the fully implanted Acclaim cochlear implant, aiming to assess its safety and efficacy for FDA premarket approval.
Key Takeaways:
- Innovative Technology – The Acclaim cochlear implant is designed to function without external components, potentially revolutionizing hearing solutions.
- Clinical Milestone – The pivotal study follows an early feasibility study and aims to validate the implant’s safety and effectiveness.
- Financial Support – The company secured $10 million in funding to advance the trial and support ongoing operations.
Envoy Medical Inc., a hearing health company focused on providing hearing loss sufferers with innovative solutions, announced the successful enrollment of the first two participants in its pivotal clinical study. The purpose of the study is to investigate the safety and efficacy of the fully implanted Acclaim cochlear implant and support its eventual premarket approval (PMA) application.Â
“We are excited to be underway with the highly anticipated pivotal clinical study of the fully implanted Acclaim cochlear implant,” says Brent Lucas, CEO of Envoy Medical. “The high level of excitement around our fully implanted cochlear implant was expected, but it is still incredibly validating to hear study sites report a great deal of interest from potential candidates. It appears, perhaps unsurprisingly, that many potential cochlear implant candidates would prefer a cochlear implant that can function without bulky externals.”
Both study participants were implanted at Ear and Hearing Center for Neurosciences in Tucson, Arizona by Abraham Jacob, MD.
“Hearing loss is the most common human sensory disability and a modifiable risk factor for dementia,” says Dr Jacob. “With no external processor and the potential for always-on hearing, the successful implantation of two patients at our center sets the fully implanted Acclaim cochlear implant system as a new benchmark within the hearing healthcare space.”
In addition to the Ear and Hearing Center for Neurosciences in Tucson, six other investigational sites were selected to be part of the study. A full list of investigational sites and additional information on the Acclaim pivotal clinical study can be found here.
Breakthrough Device
The fully implanted Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and was first implanted in three participants during an early feasibility study (EFS) at Mayo Clinic in Rochester, Minnesota in 2022.
“Over the last two years, we have learned a great deal from our early feasibility study and have been able to implement several device modifications for this pivotal clinical trial,” said Lucas, “We strongly believe our fundamental design architecture is the right way to approach fully implanted cochlear implants and may provide our device with several competitive advantages, but as a responsible medical device company, we will seek ways to continuously improve what is already a breakthrough device.”
Securing Additional Financing
The company also recently announced it has secured $10 Million in financing from its largest existing shareholder, billionaire entrepreneur Glen Taylor. The financing provides the Company with access to additional capital during what it expects to be a transformative year with several important milestones. The funds will be used to maintain the Company’s velocity through its fully implanted Acclaim cochlear implant pivotal clinical trial and support other operations.
“We are very happy with the enrollment progress in the first stage of our pivotal clinical trial,” said Envoy Medical CEO Brent Lucas, “Investigational sites are reporting a tremendous amount of interest in our fully implanted cochlear implant. We believe that interest will only grow as awareness is increased and further progress is made. We are bullish on the reported desire of many cochlear implant candidates to have a device that is designed to be completely internal.”
