Audiologist Group Has Concerns About US FDA's Proposal For OTC Sales Of Hearing Aids
ASHA Survey Shows Consumers Unaware Of Or Don't Understand Proposed Rule
With FDA proposal to allow OTC hearing aid sales mostly met with approval, American Speech-Language-Hearing Association says consumers risk further hearing loss by not consulting with professionals.
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Warren and Grassley say legislation instructing FDA to establish OTC sales of some hearing aids stated a federal regulation is needed to ensure consumers in all states benefit from the change. State AGs, on the other hand, ask FDA to “define preemption terms in a way that recognizes the important role state and local entities play in protecting consumers.”
FDA’s proposed rule aims to get more hearing aids into the ears of consumers who need them by allowing OTC sales of the devices. Proposal follows a a July executive order by President Biden directing HHS to issue proposed rules for OTC hearing aids within 120 days.
The US FDA’s proposed reg, released on 19 October, aims to get more hearing aids into the ears of those who need them by allowing the devices to be purchased over the counter.