The U.S. Food and Drug Administration (FDA) has reopened a public comment period on its draft guidance document on premarket requirements for hearing aids and personal sound amplification products (PSAPs).
The draft guidance clarifies the FDA’s different requirements for hearing aids, used by hearing impaired individuals, and PSAPs, which are designed to help amplify sounds in certain environments for non-hearing impaired individuals. In brief, the draft guidance classifies hearing aids as medical devices, subject to good manufacturing practices (GMPs) and other FDA quality system regulations (QSRs). PSAPs, on the other hand, are classified by the FDA as electronic products and are not intended for use by individuals with an actual hearing impairment.
The FDA’s decision to reopen the public comment period on the draft guidance is part of the agency’s effort to ensure the clarity of its current regulations, and to foster the development of new hearing assistance technologies that could assist the more than 37 million U.S. adults who report some form of hearing loss.
The FDA says it will accept public documents on the draft guidance document through mid-May 2016.
Read the complete text of the FDA’s draft guidance document on hearing aid devices.
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