FDAnews
www.fdanews.com/articles/68459-vivosonic-s-integrity-receives-fda-approval

Vivosonic's Integrity Receives FDA Approval

February 7, 2005

Vivosonic, a Toronto-based medical device developer, has announced FDA approval for Integrity, a wireless objective hearing-assessment system, the company said.

Integrity expands the company's objective hearing-assessment product range from Otoacoustic Emissions into Auditory Evoked Potentials (AEPs): Auditory Brainstem Response and Auditory Steady State Response. Integrity incorporates cutting-edge technologies - from the Amplitrode, the novel miniature in-situ AEP amplifier, to wireless communications and advanced digital signal-processing techniques.

With FDA approval for Integrity, Vivosonic can now expand its product offering to the U.S. market to include Auditory Evoked Potentials as well as Otoacoustic Emissions. The product can be ordered immediately for delivery in April 2005.