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Phonak Lumity - September 2023

Phonak Custom Hearing Instruments: Certificated Hypoallergenic Shell Material in 8 Colors

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Stäfa, Switzerland, December 15, 2008 - Hearing healthcare professionals are always on the lookout for solutions that enhance the overall experience of wearing hearing instruments. Phonak is proud to report that the material used for all custom product shell colors in our digital manufacturing process have been certified to be non-toxic and non-skin-irritant according to independent laboratory biocompatibility testing. Phonak demonstrates leadership in hearing instrument shell technology to compliment its digital manufacturing and signal processing innovations.

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 8 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 non-toxic and a non-skin-irritant according to independent laboratory biocompatibility testing. Phonak's shells received a rating of "0" on a 0-4 standard cytotoxicity scale;which is completely non-toxic. They also are rated 0 - 0.4 on a clinical dermal irritation test scale, which means they produce no or negligible skin reactions. These tests are compliant with ISO and U.S. Food and Drug Administration Good Laboratory Practice regulations.

As a science and technology leader, Phonak has always demanded the best performance from its products and services. Its custom products are produced from the most thoroughly tested "hypoallergenic" materials in the industry, using the most advanced, stable and precise systems available.

About Phonak

Headquartered near Zurich, Switzerland, Phonak has developed, produced and globally distributed state-of-the-art hearing systems and wireless devices for over 50 years. The combination of expertise in hearing technology, mastery in acoustics and strong cooperation with hearing health care professionals allows Phonak to significantly improve people's hearing ability and speech understanding and therefore their quality of life.

Phonak offers a complete range of digital hearing instruments, along with complementary wireless communication systems. With 2500 employees worldwide, Phonak drives innovation and sets new industry benchmarks regarding miniaturization and performance.

For more information about Phonak, please visit https://www.phonak.com/ or the Phonak Web Channel on Audiology Online.
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