Albert Schweitzer Leadership Award Presented to Austin
Beverly Hills, Calif The Albert Schweitzer Leadership Award, which honors individuals who have distinguished themselves through service to others and who have made significant contributions to the education and motivation of youth, was presented in July to William Bill Austin, CEO of Starkey Laboratories, Eden Prairie, Minn. The award is granted by the Hugh OBrian Youth (HOBY) Leadership organization, established by the actor and humanitarian, which is dedicated to seeking out and developing the leadership potential of high school students.
American presidents, cabinet members, captains of industry, and even a few celebrities comprise the past award recipients. Among his many humanitarian acts, Austin was particularly recognized for creating The Hearing Foundation, a 501(c)(3) non-profit organization that since 1978 has helped bring sound into the lives of the hearing-impaired around the globe, especially children. Each year, the foundation supports over 150 missions that provide and fit, without cost to the recipient, more than 20,000 hearing aids worldwide.
Advanced Bionics Warns of Possible CI-meningitis Risk
Sylmar, Calif Advanced Bionics Corp has warned its cochlear implant (CI) recipients and associated hearing health care professionals that there is the possibility of greater potential risk of meningitis associated with its devices. The company is recommending implant recipients to get vaccinated against pneumococcal disease, which can cause meningitis, and it has voluntarily suspended shipment of its Electrode Positioner-related products, including the Clarion C2 system in the US, until the company can determine if the Positioner is somehow involved.
The Positioner is a tool surgeons use to guide the Clarion electrode near hearing nerve fibers deep within the cochlea (see the November 1999 HR article, Update on Implant Technology, Pt 1: Cochlear Implants, page 56). It has been reported that many US surgeons disagree that the Positioner is involved in the meningitis cases, although a number of European surgeons believe it is a factor. Additionally, the cases may be predominantly associated with two implant centers located in Europe.
Meningitis is an infection and inflammation of the brain lining or spinal cord that can be treated with antibiotics. The disease can be fatal, especially if not treated quickly, and young children are particularly at risk because the various symptoms (fever, ear/headache, irritability, lethargy, and loss of appetite) often mimic the flu. All CI packaging includes warnings that implantation, in rare cases, can cause a leak of the inner ear fluid, which may result in meningitis, although there appears to have been few cases. However, during an investigation by Advanced Bionics, the company found four confirmed cases of meningitis in the last 2 years and, on June 28, it notified the Food and Drug Administration (FDA) of its findings.
On July 24, the FDA issued a public health notification (www.fda.gov/cdrh/safety/cochlear.html) citing that 25 adults and children with CIs had been diagnosed with meningitis worldwide, and the FDA was aware of nine deaths in these cases. It also noted that 2 out of 3 CI manufacturers have reported cases of meningitis in patients implanted with CIs.
There are currently 50,000-60,000 cochlear implant recipients worldwidewith most (about 40,000 since 1983) coming from Cochlear Corp, the Australia-based maker of the Nucleus implant device, and Advanced Bionics (about 10,000 total). Med-El, an Austria-based manufacturer, also provides cochlear implants. The Positioner has been used by Advanced Bionics since 1998, and about 7,000 implant recipients worldwide have the devices, says manager of marketing communications Douglas Lynch.
Although it should be understood that there is no definitive link between the meningitis cases and Advanced Bionics devices, according to Lynch, the company decided that it was prudent to suspend shipment while they investigate the data. Our responsibility as a manufacturer is to look at the product design and implantation procedure, and evaluate if its possible that they could cause problems in our implant recipients. Guided by a responsibility to the patients and our professional colleagues, weve chosen to take the greatest precautions possible while assessing this situation. The company says that the chance for contracting meningitis is extremely lowfar less than 1%and even lower if vaccinated.
According to Steven Staller, vice president of clinical, quality, and regulatory affairs for Cochlear Corp, vaccination against meningitis is recommended by the US Center for Disease Control (CDC) and the American Academy of Pediatrics for all children who receive an implant, as well as for those recipients over age 65 years. Even though there is always an increased risk of infection during head surgery, he says that an independent epidemiological review of the Nucleus implant did not show any greater incidence of meningitis than the normal surgical population.
For more information, see Advanced Bionics Web site at www.bionicear.com.
Amplifon to Purchase Sonus
Minneapolis Amplifon USA and Sonus Corp have signed a definitive agreement for Amplifon to acquire Sonus for a total of $38.4 million in cash.
Amplifon USA is a subsidiary of Amplifon SpA, Milan, Italy. Through its Minneapolis-based Miracle-Ear subsidiary, the company operates hearing aid centers at 160 corporate retail and 850 franchise retail locations in the US. Sonus, based in Portland, Ore, is one of the largest audiology-based retailers of hearing instruments in North America, with 88 company-owned retail stores and over 900 licensed network affiliates.
The acquisition of Sonus will complement Amplifons service offerings in the US with a broader range of hearing health care products available through additional distribution channels, says Jeffrey P. Bilas, president of Amplifon USA. The deal is expected to be completed by October 31, subject to shareholder approval.