US Vereinigte Staaten von Amerika
  • 03 - Dienstleistungen, Betriebswirtschaft, Verwaltung, Qualität, Verkehr, Soziologie
  • 11 - Medizintechnik
  • 90 - Optische, fotografische oder kinematografische Instrumente, Apparate und Geräte; Mess-, Prüf- oder Präzisionsinstrumente, -apparate und -geräte; medizinische und chirurgische Instrumente, Apparate und Geräte; Teile und Zubehör für diese

Hearing aids; Hearing aids (excl. parts and accessories) (HS 902140); Quality (ICS 03.120), Aids for deaf and hearing impaired people (ICS 11.180.15)

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids (42 page(s), in English)

Proposed rule - The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.