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Eargo CEO ‘Enthusiastic’ About Pending OTC Hearing Aid Sales

 
• By Brian Bossetta

The CEO of direct-to-consumer hearing aid manufacturer Eargo says an OTC category for hearing aids would improve the quality of life for many Americans with hearing loss.  

EARGO hearing aids
EARGO HEARING AIDS ARE VIRTUALLY INVISIBLE • Source: Eargo

Some top hearing aid manufacturers have tried to deter the US Food and Drug Administration from releasing a final rule that would allow hearing aids to be sold over the counter, said Sens. Elizabeth Warren, D-MA, and Chuck Grassley, R-IA.

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More from Regulation

More from Policy & Regulation

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.