The US Justice Department has launched an investigation into hearing aid maker Cochlear's use of Medicare and Medicaid programmes.
Cochlear said in a statement that the inquiry could result in "some potential criminal sanctions.
Shares in Australia-based Cochlear dropped 16% in Sydney on Friday.
Cochlear said it was co-operating fully with the request for documents on its American unit's relationships with healthcare professionals.
"It's really important that we get the message across that we're taking this very seriously," said Cochlear chief executive Chris Roberts.
Cochlear describes itself as the world market leader in ear implants.
It operates in more than 70 countries, specialising in 'bionic ear' devices to improve the hearing of severe to profoundly deaf people.