In a March 28th letter, an FDA official informed the CEO of hi HealthInnovations that the Online Hearing Test was operating without marketing approval or clearance from the FDA and was therefore illegal. He advised them to immediately remove the Online Hearing Test until a new 510(k) application has been submitted and approved by the FDA.
hi HealthInnovations removed the Online Hearing Test.
ENT Today reported on the story…More.
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