Edition: February 2003 - Vol 11 Number 02
Hearing Innovations Releases Patented HiSonic-TRD Tinnitus Relief Device
The HiSonic-TRD, the first and only device to use low-level ultrasound to treat and relieve tinnitus symptoms, is now available. The HiSonic-TRD is intended to be used for tinnitus habituation therapy and tinnitus masking therapy. The HiSonic-TRD provides immediate, effective and safe relief from the severe symptoms of tinnitus through bone-conducted ultrasound.
Tinnitus is the term for noises, which are heard “in the ears” or “in the head.” Often described as a “ringing,” these noises are also described as buzzing, whistling, hissing, pulsing or other sounds that do not come from an external source. According to The American Tinnitus Association, more than 50 million American adults have tinnitus to some degree. Of that number, 12 million suffer from severe tinnitus, causing sufferers to seek medical attention for loss of concentration, sleep problems and psychological distress. Many patients are so seriously debilitated that they cannot function on a normal, day-to-day basis due to extreme distress, depression and, in the worst cases, suicidal tendencies.
Hearing Innovations’ HiSonic-TRD is now being made available to consumers by prescription from their licensed audiologist, Otolaryngologist (Ear, Nose & Throat physician) or local hearing center.
Hypoguard Announces Receipt of CLIA Waiver Status for DiaScreen 50 Urine Chemistry Analyzer
Hypoguard recently announced receiving CLIA Waiver status from the FDA for the DiaScreen 50 Urine Chemistry Analyzer.
The DiaScreen 50 is an automated instrument designed for use with DiaScreen Reagent Strips for Urinalysis. It saves time for technicians, allowing them to be more efficient, while the analyzer is computing test results. It has a throughput of 50 strips per hour and a memory capacity of 200 test results, which may be downloaded to a PC. The DiaScreen 50 virtually eliminates transcription errors with an easy-to-read printout. It minimizes variability in results between operators. Patient identification may be entered with the standard keypad, a barcode reader or PC keyboard.
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. CLIA regulations cover both the tests and the entities that perform the tests. Under CLIA, all commercially marketed in vitro diagnostic test systems are assigned to one of three CLIA regulatory categories based on their potential risk to public health and the complexity of performing the test. These categories are: Waived, Moderate Complexity and High Complexity.
The DiaScreen 50 analyzer has been on the market since February 2002 upon receipt of FDA marketing clearance and has been available for sale to laboratories of moderate and high complexity. Now, with the CLIA waiver status, the DiaScreen 50 analyzer may also be sold to CLIA waived laboratories, including physician office laboratories.
BD LAUNCHES PASSIVE-RETRACTION IV CATHETER
Becton, Dickinson and Company recently announced the launch of the BD Autoguard Pro shielded IV catheter, the first passive version of the Company’s Autoguard family of IV catheters. The new product is available immediately and will join BD’s extensive array of safety-engineered medical devices that help to protect healthcare workers from accidental needlesticks.
The BD Autoguard Pro shielded IV catheter incorporates a unique passive retraction feature developed by Med-Design Corporation and licensed exclusively to BD. The spring-based technology automatically retracts the insertion needle into a shielded housing as the clinician withdraws the needle from the catheter after insertion into the vein.
Bill Marshall, vice president of BD Medical Systems Infusion Therapy, said, “BD is committed to offering the widest selection of catheter products for every procedure and clinical preference. The BD Autoguard Pro(tm) shielded IV catheter will help protect health care workers from injury and infection and help them deliver the highest-quality patient care.”