Health Highlights: March 28, 2008
Here are some of the latest health and medical news developments, compiled by editors ofHealthDay:
FDA Seeks $2.2 Million Penalty from Hearing Aid Maker
Hearing aid maker Advanced Bionics LLC is being penalized $2.2 million by the U.S. Food and Drug Administration for alleged violations including failing to adhere to manufacturing standards and for failing to notify the agency that it had changed suppliers, the FDA said Friday.
The Sylmar, Calif., company makes a device called the HiRes90k Implantable Cochlear Stimulator. The device is surgically implanted behind the ear to treat profound hearing loss in both adults and children.
The agency's legal complaint alleges that the company exposed device users to unnecessary health risks by failing to follow standard manufacturing procedures and by distributing devices that contained a component provided by an unapproved vendor.
The complaint says Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. At least some of the alleged violations occurred after a 2001 inspection, which had found similar failures that the company had promised to correct, the agency said.
Brain Changes Affect Teen Behavior
Natural changes in adolescents' brains affect their cognition, emotion and behavior, say U.S. National Institute of Mental Health researchers, who used MRI to examine the brains of volunteers.
The researchers found that brain gray matter increases in volume until the early teens, then decreases until old age. The findings appear in the April issue of theJournal of Adolescent Health.
"Adolescence is a time of substantial neurobiological and behavioral change, but the teen brain is not a broken or defective adult brain," wrote researcher Dr. Jay N. Giedd.
The findings come from the NIMH Longitudinal Brain Imaging Project, which began in 1989.