Cochlear.

Cochlear, Englewood, CO, Mar. 2 (CDRH-OC). FDA's reviews of the firm's promotional material for the Nucleus 22 pediatric implant found three claims to be excessive. "No one has better clinical results" was deemed inappropriate due to the fact that test subjects were "post-lingual adults." The second claim deemed out-of-bounds was "No one has better technology." The letter called for clarification of the basis of this claim, whether based on device characteristics or "better clinical speech perception results." The third claim, that "No one has better hearing in noise" was refuted because the agency believed the data, as a whole, are inadequate to support the claim. The letter suggested that statements of contraindications include five conditions including tympanic membrane perforation, that warnings include unknown long-term effects of use, and that adverse effects include the statement that implantation of the device "will result in complete loss of residual hearing in the implanted ear." The letter also noted complaints the firm had lodged against Advanced Bionics and Med El. F-B