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.
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.
The lawmakers allege the “dominant” hearing aid manufacturers submitted comments to the FDA under the guise of “independent” citizens to undermine the popularity of the agency’s proposed rule, which would...
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
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.
