The Federal Register confirmed earlier this week that the new version of ANSI S3.22-2003 will be incorporated into the Hearing Aid Regulation effective October 15, 2008 and WILL NOT apply to hearing aid models already on the market.
On October 8th, FDA published its Direct Final Rule;Confirmation of Effective Date amending hearing aid labeling to reference "the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids." Noting that the Agency received only one comment on the proposed rule (HIA comment filed August 15, 2008) requesting that the proposed change only be applied to new hearing aid models, the notice states that "FDA agrees...that hearing aid models tested prior to (October 15, 2008) are subject only to the characterization standard cited in the regulation at the time that they were tested."
The result could not be more clear or more positive. This decision has no adverse effects and, indeed, will save member companies thousands of hours and substantial expense. Thanks again to Sonic Innovations, Starkey, and Widex for shepherding this initiative successfully.
HIA Prevails at FDA
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