This page is part of our public exclusion list — a transparency tool that shows which companies we screen out and why. It is not investment advice, and it is not an accusation. But it is subject to change as our understanding of the facts evolves.
Envoy Medical Inc. develops and seeks to commercialize the Acclaim fully implanted cochlear implant system. The company's regulatory filings with the U.S. Food and Drug Administration explicitly state that an Investigational Device Exemption (IDE) application for such a medical device "must be supported by appropriate data, such as animal ..." data. This indicates the product's development pathway relies on animal testing to generate the necessary safety and efficacy evidence for regulatory approval. The Acclaim device is the company's lead and only product candidate, making this testing central to its business model. In November 2025, the FDA issued a warning letter to Envoy Medical citing significant quality system violations observed during an inspection, though the specific details of those violations were not publicly detailed in the source material.
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A digest of changes to our exclusion list — new additions, removals, and the evidence behind them. We review the list continuously as new evidence surfaces.
Companies appear on our exclusion list based on our investment judgment — not because they've done anything illegal. This is a difference of values and opinion, not an accusation of wrongdoing. Exclusion does not constitute a recommendation against investing in any company, and absence from the list does not constitute a recommendation to invest.
This information is provided for educational and transparency purposes only and should not be relied upon as investment advice. Data is drawn from independent watchdogs, NGOs, government registries, and Ethical Capital's ongoing research — see Research Sources for the full list.
Ethical Capital LLC is a state-registered investment adviser in Utah (CRD #316032). Registration does not imply a certain level of skill or training.