The Food and Drug Administration (FDA) is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. FDA first alerted the public to the theft in June 2009.
Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. The agency has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial...
While these personal sound amplifiers may help people hear things that are at low volume or at a distance, the Food and Drug Administration (FDA) wants to ensure that consumers don't mistake them—or use them as substitutes—for approved hearing aids.
"Hearing aids and personal sound amplification products (PSAPS) can both improve our ability to hear sound," says Eric Mann, M.D., Ph.D, deputy director of FDA's Division of Ophthalmic, Neurological, And Ear, Nose, and Throat Devices. "They are both wearable, and some of their technology and function is similar."
Mann notes, however, that the products are different in that only hearing aids are intended to make up for impaired hearing.
He says consumers should buy a personal sound amplifier only after ruling out hearing loss as a reason for getting one. "If you suspect hearing loss, get your hearing evaluated by a health care professional," he adds.
Choosing a PSAP as a substitute for a hearing aid can lead to more damage to your hearing, says Mann. "It can cause a delay in diagnosis of a potentially treatable condition. And that delay can allow the condition to get worse and lead to other complications," he says.
Treatments for impaired hearing can be as simple as removal of a wax plug in the doctor's office or, in rare cases, as serious as a major surgery to remove a tumor or growth in the middle or inner ear, says Mann.
How They Differ
In March 2009, FDA issued guidance describing how hearing aids and personal sound amplifying devices differ.
The recently issued guidance defines a hearing aid as a sound-amplifying device intended to compensate for impaired hearing.
PSAPs are not intended to make up for impaired hearing. Instead, they are intended for non-hearing-impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities.