Audiology In Brief Natus initiated a voluntary device recall to ensure that SonaMed Clarity devices are no longer used for newborn hearing screening. The company cited concerns about whether the device could lawfully be used to comply with requirements of the U.S. Food and Drug Administration (FDA) and other pertinent professional guidelines/standards ... News in Brief
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News in Brief  |   August 01, 2010
Audiology In Brief
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Hearing Disorders / News in Brief
News in Brief   |   August 01, 2010
Audiology In Brief
The ASHA Leader, August 2010, Vol. 15, 5. doi:10.1044/leader.NIB.15092010.5
The ASHA Leader, August 2010, Vol. 15, 5. doi:10.1044/leader.NIB.15092010.5
Natus Recalls Hearing Screeners
Natus initiated a voluntary device recall to ensure that SonaMed Clarity devices are no longer used for newborn hearing screening. The company cited concerns about whether the device could lawfully be used to comply with requirements of the U.S. Food and Drug Administration (FDA) and other pertinent professional guidelines/standards for newborn hearing screening.
Specifically, the FDA has not cleared the Clarity as an “automated” screener and it cannot lawfully be used by anyone other than an audiologist or trained health care professional knowledgeable about the use of audiometers.
The device is not supported by any published documented sensitivity or specificity rates for the detection of hearing loss in newborns, and it does not conform to the Joint Committee on Infant Hearing recommendation that newborn hearing screening devices incorporate an automated statistical method. Visit Natus’ website for more information.
Pediatric Vestibular Disorders
Anxiety disorders and migraine are often associated with vestibular disorders in children, according to AgnesКSzirmai at Semmelweis University in Budapest, Hungary. The researcher analyzed data from the last five years from 145 children who experienced vertigo. The participants were divided into two groups: 66 children up to age 14 and 79 adolescents ages 14–18. Detailed case histories, routine physical examinations, and cochlear function tests showed that most of the children and adolescents experienced true rotary vertigo. Of the participants, 64% of children and 61% of adolescents had vestibular abnormalities. The most frequent cause of dizziness (24%) in the adolescent group is the panic disease and anxiety disorder that resemble extravestibular disorders. At younger ages, the most frequent cause of vestibular symptoms is migraine. View the May 20 issue of the European Archives of Oto-Rhino-Laryngology online.
Call for Award Nominations
The National Institute for Occupational Safety and Health, in partnership with the National Hearing Conservation Association (NHCA), is accepting nominations for the 2011 Safe-in-Sound Excellence in Hearing Loss Prevention Awards.
The competition uses key performance indicators to evaluate nominated hearing loss prevention programs in each of three industrial sectors: manufacturing, construction, and services. Individuals or organizations in any sector also may be recognized for their dedication to fostering, creating, and implementing new and unique advances in the prevention of hearing loss.
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August 2010
Volume 15, Issue 9