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Tag: de novo

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Neuromod Devices’ Lenire Receives De Novo Approval from FDA

Neuromod Devices’ Lenire Receives De Novo Approval from FDA

Neuromod Devices' Lenire, a bimodal neuromodulation device, has received De Novo approval from the FDA to treat tinnitus. According to the company, Lenire is the first of its kind to receive FDA approval.

  • IotaMotion, Inc Announces Completion of Robotics-Assisted Cochlear Implant Insertions Using IotaSOFT System

  • Service-Delivery Considerations of Direct-to-Consumer Devices in the New Age of Rehabilitative Hearing Healthcare

  • FDA Announces Revamping of Product Approvals and 510(k) Program

  • New Self-fitting Hearing Aid Class and Special Controls Described by FDA Letter

  • Blog: Gleanings from Bose Leaders about the Bose Hearing Aid

  • Blog: Observations on FDA Granting De Novo Status for Bose Hearing Aid

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