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Biden Joins House And Senate Asking For FDA's Attention On Making Hearing Aids Available OTC

Executive Summary

One of 72 items in an executive order by the president on promoting competition in the economy notes that 14% of the around 48m US consumers with hearing loss use hearing aids because, on average, they cost more than $5,000 per pair, costs often not covered by health insurance.

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Senators Emphasize Federal Pre-emption In US OTC Hearing Aid Rule, State Attorneys General Disagree

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.”

Facilitating More OTC Switches In US Graduates To Regulatory Plan On FDA’s Unified Agenda

For first time rules for novel switches and OTC hearings aids are parts of “significant regulatory actions” in agency’s plans. Information is added in Unified Agenda items explaining likely benefits and costs from the changes.

Audiologist Group Has Concerns About US FDA's Proposal For OTC Sales Of Hearing Aids

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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