1. Medtech Insight
  2. >>Device Area

Senators, State AGs Differ On Whether Further Federal Regulation Needed For OTC Hearing Aids

 
• By Malcolm Spicer

Sens. Warren and Grassley say federal regulation is needed to ensure consumers in all states benefit from OTC hearing aids. State AGs, on the other hand, have asked the FDA to “define preemption terms in a way that recognizes the important role state and local entities play in protecting consumers.”

US Congress
• Source: Alamy

A US Food and Drug Administration proposal to allow OTC sales of some hearing aids got state attorneys general listening, while two senators asked the FDA to ensure a federal regulation would pre-empt all state laws concerning the devices.

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
Start Free Trial

Already a subscriber?

More from Durable Medical Equipment

FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health

 
• By Brian Bossetta

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

Latest Philips Recall Linked To Death, Injuries

 
• By Brian Bossetta

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

X-ray Regulations Detailed In New FDA Guidance

 
• By Brian Bossetta

The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.

Device Shortages A Matter Of National Security, Califf Says

 
• By Brian Bossetta

During an online seminar hosted by the Alliance for a Stronger FDA, Commissioner Robert Califf discussed key issues facing the agency, including supply chains, device shortages, and the risk of another pandemic.

More from Device Area

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
• By Elizabeth Orr

The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.

Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
• By Marion Webb

Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.