Envoy Medical (COCH) said Friday the US Food and Drug Administration approved its investigational device exemption application to start a pivotal clinical trial of the Acclaim Cochlear Implant hearing device.
The Acclaim technology has an implanted sensor designed for the natural anatomy of the ear to capture sound, the company said.
The Acclaim Cochlear Implant received the FDA's breakthrough device designation in 2019, the hearing health company said.
Envoy shares were nearly 12% higher in recent premarket trading.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。