Medical Devices; Guidance for Industry and FDA Staff; Implantable Middle Ear Hearing Device; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance for Industry and FDA Staff; Implantable Middle Ear Hearing Device." This guidance document represents the agency's current thinking on the technical content and clinical considerations for a premarket approval application (PMA) for an implantable middle ear hearing device (IMEHD). This guidance provides information to consider for developing the clinical studies and generating the scientific evidence that will provide reasonable assurance of safety and effectiveness of the IMEHD for its intended use.