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US Lawmakers: Hearing Aid Manufacturers Tried To Undermine OTC Proposal

Deceptive comments were meant to mislead; Hearing Industries Association in hot water?

 
• By Brian Bossetta

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.

Hearing Loss
• Source: Shutterstock

Nearly half of the comments submitted to the US Food and Drug Administration on the agency’s proposed rule to establish an over-the-counter (OTC) hearing aid category were part of scheme by some in the industry to undermine and weaken the proposal, Sens. Elizabeth Warren, D-MA, and Chuck Grassley, R-IA, allege.

The FDA in January received more than a thousand comments to a proposed rule it published in October 2021 that would allow consumers with “mild to moderate” hearing loss to purchase the devices without a prescription

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New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
• By Elizabeth Orr

NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.

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

 
• By Brian Bossetta

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.

Global Medtech Guidance Tracker: April 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.