Implantable Middle Ear Hearing Device Control Comparison Weighed By CDRH
This article was originally published in The Gray Sheet
Executive Summary
FDA will need to decide whether a planned guidance on implantable middle ear hearing devices should allow sponsors to control against unaided conditions
You may also be interested in...
FDA Implantable Middle Ear Draft Guidance Follows Panel Recommendations
Direct comparisons of conventional hearing aids to implantable middle ear hearing devices should be performed when preparing a premarket approval application, according to an FDA 1draft guidance
Symphonix Vibrant Soundbridge Claims Should Reflect Data Subjectivity
Labeling claims should reflect the subjective nature of data obtained from clinical studies supporting FDA approval of Symphonix Devices' Vibrant P and Vibrant D "Soundbridge" implant hearing system, FDA's Ear, Nose and Throat Devices Panel concluded at a July 20 meeting in Gaithersburg, Maryland.
Entries Begin To Roll In For 2024 Industry Awards
Entries have now begun rolling in for the Global Generics & Biosimilars Awards, which returns to Milan this October, Free to enter and attend, the ceremony recognizes the top achievements across the generics, biosimilars and value added medicines industries.