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Phonak introduces hypoallergenic hearing aid shells

Phonak has announced that the material used for all custom product shell colors in its digital manufacturing process has been certified to be nontoxic and nonirritating according to independent laboratory biocompatibility testing. You can see the latest Phonak hearing aid models here

In 2007 after several years of development, Phonak introduced an advanced digital manufacturing process to all major custom production centers worldwide. This process uses proprietary 3D modelling software to create a virtual custom hearing instrument. The shell is automatically constructed layer by layer from medical grade acrylic using computer-controlled UV light exposure. All equipment is rigidly calibrated and operated according to strict process quality control standards. The dimensional precision and consistency of the hearing instrument shell is clearly a main benefit of this process. But an additional advantage of Phonak’s digital manufacturing process is the mechanical stability and bio-compatibility of the shell material. For many years custom hearing instrument shells were produced using a hand-poured manual process which resulted in shells that often varied in their mechanical properties.

Phonak has worked with one of the leading producers of specialty medical grade UV-curable acrylics to develop and fine-tune eight different colors of shell materials: pink, tan, cocoa, brown, red, blue, transparent, and white. Acrylic polymers are resistant to many biological and chemical agents and demonstrate excellent impact strength, dimensional stability, chemical and scratch resistance, biocompatibility and clarity.

All Phonak custom hearing instrument shells and SlimTips produced using their digital manufacturing process have been certified to be nontoxic and a nonirritating according to independent laboratory biocompatibility testing. Phonak’s shells received a rating of “0” on a 0-4 standard cytotoxicity scale; which is completely nontoxic. They also are rated 0 – 0.4 on a clinical dermal irritation test scale, which means they produce either no or negligible skin reactions. These tests are compliant with ISO and US Food and Drug Administration Good Laboratory Practice regulations.

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