Hearing News and Research

RSS

FDA issues final guidance for public's comments at advisory committee meetings

The U.S. Food and Drug Administration today issued final guidance for people who wish to comment during the agency's advisory committee meetings. The guidance provides instructions on how to request a time to speak and how FDA staff should respond to requests to speak at the meetings.

13 Dec 2010

New study says boxers are at substantial risk for acute injuries to head, heart, and skeleton

Boxers are at substantial risk for acute injuries to the head, heart, and skeleton. Subacute consequences after being knocked out include persistent symptoms such as headaches, impaired hearing, nausea, unstable gait, and forgetfulness.

13 Dec 2010

Ramius to acquire Cypress Bioscience

Ramius V&O Acquisition LLC, a subsidiary of Ramius LLC (collectively, "Ramius"), today announced that it has sent a letter to the Board of Directors of Cypress Bioscience, Inc. outlining its willingness to acquire all of Cypress' outstanding Common Stock in a negotiated transaction for $5.50 per share. The offer is conditioned upon Cypress commencing exclusive negotiations with Ramius no later than Friday, December 10, 2010 and entering into a definitive merger agreement by no later than Sunday, December 12, 2010.

10 Dec 2010

New challenges to FDA's 'no risk' classification of mercury fillings

FDA Device Division, still concerned about mercury toxicity in American dentistry, is convening yet another professional panel review regarding safety issues. A nationwide convergence of scientists, dental and medical professionals, lead by the International Academy of Oral Medicine and Toxicology (IAOMT) are provoking new challenges to the Food and Drug Administration's (FDA) July'09 "no risk" classification of mercury fillings .

10 Dec 2010

Sound masking therapy is of uncertain benefit when used alone to treat tinnitus

Tinnitus — what many think of as "ringing in the ears" — is the perception of sound without any real acoustic stimulation. Sound masking therapy, a common component of tinnitus treatment, is of uncertain benefit when used on its own, a new evidence review finds.

10 Dec 2010

Repeated cerebral trauma in boxing career may result in boxer's dementia

Up to 20% of professional boxers develop neuropsychiatric sequelae. But which acute complications and which late sequelae can boxers expect throughout the course of their career? These are the questions studied by Hans Förstl from the Technical University Munich and his co-authors in the current issue of Deutsches Ärzteblatt International (Dtsch Arztebl Int 2010; 107[47]: 835-9).

10 Dec 2010

Powerful GOP lawmakers clarifying plans for cutting health costs, repealing reform law

The Republican lawmaker who will take the chair of the House's main investigative committee has made clear his interest in examining the overuse of expensive medical procedures while a newly tapped GOP subcommittee chief pledges to "dismantle Obamacare." Meanwhile, the food safety bill has been folded into must-pass legislation to fund the U.S. government.

10 Dec 2010

European researchers develop new form of therapy for Alpha-mannosidosis

Alpha-mannosidosis is a rare childhood disease which causes symptoms such as mental retardation or hearing loss and is linked to a lower life expectancy. A European research team headed by Professor Paul Saftig from Christian-Albrechts-Universit-t zu Kiel has developed a form of therapy as part of the Alpha-Man project, which will receive around six million euros from the European Union for its next stage of trials.

9 Dec 2010

FDA advisory committee's approval of Contrave for obesity encourages OAC, TOS, ASMBS

The Obesity Action Coalition, The Obesity Society and the American Society for Metabolic and Bariatric Surgery found encouragement in the outcome of today's advisory committee hearing, favoring approval for the first new obesity treatment in more than 10 years.

8 Dec 2010

Microsurgical technique effective in removing acoustic tumors

Surgery to remove tumors under the brain known as acoustic neuromas produces favorable outcomes in the "vast majority" of patients, according to one of the largest studies of its kind.

8 Dec 2010

Conn. addresses insurance rates, Mass. physician groups evaluate controversial payment plan

"House and Senate leaders are eyeing passage of a second midyear spending bill before the start of the next legislative session to address more caseload-driven accounts that are running short on funds five months after Gov. Deval Patrick signed the fiscal 2011 budget. The deficiencies, which follow inaccurate enrollment estimates for MassHealth and other social service programs, threaten to eat into some the revenue surpluses the state has amassed over the first half of fiscal 2011, when tax receipts have exceeded projections" (Murphy, 12/7).

8 Dec 2010

Psychotic depression: the reason for treatment failure with antidepressants

A new study shows that patients with depression who also have psychotic-like symptoms, feelings of being persecuted, or believing others are plotting against them or hearing voices are less likely to respond to antidepressants. The study also showed that bipolar disorder does not appear to be associated with treatment resistance in patients with depression as believed earlier.

7 Dec 2010

Report: Baltimore cardiologist inserted 'medically unnecessary' stents

Abbott Laboratories, a $30 billion-a-year, Chicago-based pharmaceutical firm, ranked [Dr. Mark] Midei among its top-volume doctors in the Northeast and made plying him with research money and 'VIP trips' part of its business plan in late 2008 — about the time Midei's usage of Abbott-brand stents soared, the report said.

7 Dec 2010

MenAfriVac to help health workers eliminate meningococcal A epidemics

The West African nation of Burkina Faso today became the first country to begin a nationwide campaign to introduce a new meningitis vaccine that promises to rid the entire region of the primary cause of epidemic meningitis. The first vaccine designed specifically for Africa, MenAfriVac is expected to help health workers eliminate meningococcal A epidemics in the 25 countries of the meningitis belt, stretching from Senegal in the west to Ethiopia in the east.

6 Dec 2010

Texas gov. Perry backs away from Medicaid dropout threat

Medicaid and the Children's Health Insurance Program are breaking the state's budget, but opting out of the federal programs would have a devastating effect on health care delivery in Texas, according to a state report issued Friday. The report said most of the methods for fixing Medicaid spending in Texas will require acts of Congress, not the Legislature, to give the state greater flexibility in how the programs are run and a greater share of the national Medicaid financing.

6 Dec 2010

Health insurance news: Conn. rejects Anthem BC/BS rate increase, stock prices 'steady' despite reform law

The state Insurance Department refuted charges Friday by a nonprofit health-policy research group that Connecticut insurance regulators are understaffed and approve only minor changes to health-insurance rate hikes. Acting Insurance Commissioner Barbara C. Spear reacted to a report released this week by the Kaiser Family Foundation that said the state Department of Insurance 'has only one full-time actuary on staff' assigned to review rate filings for both the individual and small-group markets. ... 'Staffing levels do not have anything to do with the thoroughness of our rate review process,' Spear said." (Sturdevant, 12/13).

6 Dec 2010

Elimination of first month purchase option for power wheelchairs will hurt Medicare beneficiaries in rural areas

For 12 years, Gerald Sloan, owner of Progressive Medical Equipment, LLC, has provided home medical equipment to Medicare patients from his retail outlets near Kansas City and St. Louis, and he is also vice president of the Midwest Association for Medical Equipment Services (MAMES). Today, Sloan is concerned that the elimination of the first month purchase option for Medicare beneficiaries requiring power wheelchairs will prevent patients in rural areas from receiving the mobility assistance that has been prescribed by their physicians.

4 Dec 2010

Discovery Labs plans to file request for hearing over Nasdaq delisting notification

Discovery Laboratories, Inc., announced today that, on November 30, 2010, the Company received a Staff Determination letter from The Nasdaq Stock Market indicating that the Company has not established compliance with Nasdaq Listing Rule 5550(a)(2) ("Minimum Bid Price Rule") because the Company's common stock did not maintain a minimum closing bid price of $1.00 per share over a period of 10 consecutive business days ending on or prior to November 29, 2010.

3 Dec 2010

Justice Department offers expedited antitrust review for ACOs

Bloomberg: "Sharis Pozen, chief of staff of the [Justice] Department's antitrust division, told a House judiciary subcommittee" that "[t]he department intends to offer whatever guidance and clarity may be needed to ensure that providers pursue beneficial integrated ACOs without running afoul of the antitrust laws."

3 Dec 2010

At Senate hearing, Democrats blast 'mini-med' insurance policies

The New York Times: "More than a million Americans enrolled in [limited benefit, or mini med,] plans think they have health insurance to protect them from financial catastrophe if they become seriously ill or hurt, [Senator John D.] Rockefeller said. 'In fact, they don't,' he said. 'It's worse than nothing because of the false expectations and the false hope,' Mr. Rockefeller said" at the Senate hearing.

2 Dec 2010