Warren, Becerra And Califf Visit Walgreens In OTC Hearing Aid Launch
The Massachusetts Senator, HHS secretary and FDA commissioner held a drug store event to mark the new availability of hearing aids without a prescription.
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The US FDA has finally established a new regulatory category for hearing aids that will allow Americans with mild to moderate hearing loss to purchase the devices directly over the counter without a prescription or prior exam.
Some of the top hearing aid firms engaged in fraudulent messaging to undercut the sale of hearing aids directly to consumers, according to a bipartisan Senate investigation.
President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.