FDAnews Device Daily Bulletin

HEARING AID COMPANY FILES APPEAL CHALLENGING MISSOURI STATUTE

May 15, 2006
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Illinois company Hearing Health Express May 11 filed an appeal in the U.S. Court of Appeals for the Eighth Circuit against the Missouri Board of Examiners for Hearing Instrument Specialists, which has sought to prevent the company from selling hearing aids to Missouri residents "without the prior fitting or testing required by state law."

Hearing Health Express says that a Missouri statute the board is relying on to regulate the company's sales of hearing aids -- which are conducted primarily through the mail and over the internet -- is preempted by the Medical Devices Amendment (MDA) to the Federal Food, Drug and Cosmetic Act. The company also contends the Missouri board's action violates the federal Commerce Clause.

The company is appealing a district court decision and contending that the Missouri statute is preempted by the MDA because the state requirements are "in addition to" federal requirements relating to consumer safety and device effectiveness. The Missouri board contends that the state statute is not preempted because it deals only with fitting and testing, which it says are not federally regulated under the MDA.