Business · 21/01/2016Updated: 10/17/2026 · 1 min read
FDA Classifies Tympanic Membrane Contact Hearing Aid into Class II with Special Controls
Summary
The FDA has classified the tympanic membrane contact hearing aid into Class II, requiring special controls to ensure the device provides a reasonable assurance of safety and effectiveness.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →