Phonak Introduces Hypoallergenic Shell MaterialBy Hearing Review - The Insider,
Publication Date: December 24, 2008
Article describes the manufacturing process of hearing instrument shells made by the Swiss hearing aid company Phonak. The acrylic shells were certified to be nontoxic and nonirritating according to independent laboratory biocompatibility testing, receiving a rating of 0 on a 0-4 standard cytotoxic scale, which is completely nontoxic, and a 0-0.4 on a clinical dermal irritation test scale, which means they produce either no or negligible skin reactions. The tests are compliant with US Food and Drug Administration Good Laboratory Practice regulations. According to the article, the mechanical stability and bio-compatibility of the shell material produced by this digital manufacturing process is an improvement over the hand-pouring process used for many years, which resulted in shells that often varied in their mechanical properties.
Published by: Ascend Media LLC (Website:http://www.ascendmedia.com)
Link to text: http://www.hearingreview.com/insider/2008-12-24_05.asp