1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Comments On US FDA OTC Hearing Aid Proposed Rule Urge Clarification On Recommended Users

 
• By Malcolm Spicer

More than 1,000 comments were submitted by professional and civic organizations, trade groups and consumers FDA proposed rule on allowing OTC sales of hearing aids intended for consumers with mild to moderate hearing loss.

PICTURE OF HEARING AID.
• Source: Alamy

Stakeholders commenting on a proposal from the US Food and Drug Administration that would allow the over-the-counter sale of some hearing aids raised several concerns, including labeling that “minimizes who the device is not for” and that the proposal doesn’t require marketers to accept product returns.

More than 1,000 comments have been submitted by professional and civic organizations, trade groups and consumers on the October proposed rule that would allow nonprescription sales of hearing aids intended for consumers with mild to moderate hearing loss

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 Regulation

More from Policy & Regulation

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.