Hear! Hear! Industry Responds To FDA Proposal On OTC Hearing Aids

Poll finds few Americans know about the proposal

The FDA’s recent proposal to allow hearing aids to be sold over the counter without a prescription has mostly been met with approval. Many Americans, however, are unaware of the plan.

WOMAN HOLDING GRAMMOPHONE.
• Source: Alamy

Many Americans with trouble hearing never do anything about it. This is due, in large part, to the high cost of hearing aids and the hoops one must jump through – exams, fittings – to get them. But that could all change, with the US Food and Drug Administration set to approve the sale of hearing aids over the counter without a prescription or prior medical exam.(Also see "No Prescription? No Problem: FDA Draft Rule Gives Green Light To OTC Hearing Aids" - Medtech Insight, 19 October, 2021.)

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By 

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

 

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

More from Policy & Regulation

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By 

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

 

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

 

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.