Introduction
As hearing aids become smarter and more connected, their protection needs grow more complex. These miniature medical devices face daily exposure to sweat, humidity, and accidental splashes—making reliability under real-world conditions a non-negotiable priority.
At the same time, tightening global chemical regulations—especially around PFOA and PFAS substances—are forcing medical device manufacturers to rethink their protective strategies.
P2i is at the forefront of this transformation, delivering high-performance, PFOA-free and PFAS-free coating solutions that meet regulatory mandates while enhancing product performance and longevity.
Regulatory Urgency: What’s Changing?
Global restrictions on PFOA-related chemistries are now in force. One of the most pressing deadlines is the EU 2020/784 regulation, which ends the exemption for invasive and implantable medical devices by 4 July 2025.
- Failure to comply could result in:
- Market access restrictions in Europe and other regulated regions
- Fines and commercial risk
- Damage to brand credibility
P2i’s Dual Commitment: Compliance + Performance
P2i offers a field-proven, PFOA-free molecular coating, originally launched in 2010, tailored specifically for hearing aids. Our patented technology delivers:
- Water, sweat, and humidity protection at the microscopic level
- No added bulk—preserves device design and acoustic performance
- No degradation over time, unlike mechanical seals or gaskets
- Reliable protection without solvents, PFAS, or PFOA-related substances
This means you can exceed compliance requirements—not just meet them—and still deliver world-class performance to your customers.
Fast Integration for a Fast-Moving Market
P2i understands that compliance timelines are tight. That’s why our coating solutions are engineered for rapid deployment and integration within existing production lines.
- Collaborative engineering support from our global teams
- Custom process configuration for your device specs
- Proven reliability in mass-market consumer electronics and medical devices
Why Leading Hearing Aid Brands Choose P2i
- Proven technology in use since 2010
- PFAS-free and PFOA-free for complete peace of mind
- Enhanced device reliability, fewer returns, happier customers
- Lower cost of ownership than traditional seals or legacy coatings
Sustainability and Future-Proofing
Beyond regulation, consumers and investors increasingly demand environmental responsibility. P2i’s chemistry aligns with future regulations and ESG standards, ensuring your brand leads—not follows—the sustainability curve.
Final Word
The countdown to compliance is on. But compliance alone isn’t enough. Hearing aid manufacturers must also protect brand integrity, user experience, and product reliability.
P2i offers the proven solution—backed by science, trusted by leaders.
Contact us today to get regulatory-ready and market-optimized.