Iowa Judge Denies Manufacturer Summary Judgment in HiRes Cochlear Implant Case

ONAWA, Iowa — An Iowa federal judge has denied the manufacturer of cochlear implant summary judgment on claims that it violated the device’s premarket approval by substituting its feedthru assembly with one made by a different vendor.

On July 24, Judge Mark W. Bennett of the U.S. District Court for the Northern District of Iowa found these claims are “parallel” to federal requirements.

Dennis and Melissa Eggerling’s minor daughter was prescribed a cochlear implant, the Advanced Bionics HiRes 90k, to treat her permanent hearing loss. A leak in the device’s feedthru assembly, made by outside vendor AstroSeal, caused the cochlear …