Testing and material selection for sensitive ear canals

Why does the ear react so sensitively to unsuitable materials? The skin inside the ear is as thin as tissue paper and has virtually no subcutaneous fat. Foreign substances quickly cause redness or itching there. That is why every component worn for more than a few minutes undergoes strict biocompatibility testing according to ISO standards for medical devices.

Materials in detail

For direct skin contact, we use medical-grade silicone. This polymer contains no plasticizers and adapts to body heat within seconds. This makes it supple and seals the sound canal without creating a sensation of pressure. The outer housing, on the other hand, consists of ABS polymer, a thermoplastic that absorbs daily impacts and withstands sweat. Cleaning instruments are crafted from stainless steel so they remain resistant to moisture and can be boiled sterile.

• Quality testing: Every silicone component is inspected for elasticity and smooth, burr-free surfaces before shipment.
• Traceability: All plastics used carry complete certificates of origin in accordance with European safety standards.

Why this matters for your day

Good materials feel unnoticeable after just a few minutes. They prevent moisture buildup and ensure you can wear your system for hours without skin fatigue or burning sensations.