The reported adverse is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Poor sound quality and the experience of the recipient not getting enough gain with the attract system can be the result of many things.One reason can be a natural decrease in the recipients hearing, another thing can be that recipient has put on weight and the skin flap between the magnets has got thicker which reduces the gain.This report is submitted on april 25, 2022.
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