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Evaluating the Safety and Usability of an Over-the-Counter Medical Device for Adults With Mild to Moderate Hearing Loss: Formative and Summative Usability Testing.
JMIR Hum Factors
January 2025
Center for Research and Innovation in Systems Safety, Department of Anesthesiology, Vanderbilt University Medical Center, 2525 West End Avenue, Suite 800, Nashville, TN, 37203, United States, 16153431528.
Background: Only 15% of the nearly 30 million Americans with hearing loss use hearing aids, partly due to high cost, stigma, and limited access to professional hearing care. Hearing impairment in adults can lead to social isolation and depression and is associated with an increased risk of falls. Given the persistent barriers to hearing aid use, the Food and Drug Administration issued a final rule to allow over-the-counter hearing aids to be sold directly to adult consumers with perceived mild to moderate hearing loss at pharmacies, stores, and online retailers without seeing a physician or licensed hearing health care professional.
View Article and Find Full Text PDFPitfalls and perils from FDA-approved germ-line cancer predisposition tests.
Oncotarget
December 2024
The FDA approval on September 29, 2023, for "class III " blood tests to assess hereditary cancer risk make widely available tests that may be obtained through a Direct to Consumer (DTC) path. There is concern that germ-line predisposition tests may not be reimbursed by insurance adding financial burdens to individuals and families. It is generally agreed in the fields of oncology and genetics that germ-line testing for disease susceptibility including cancer is best performed under care of a healthcare provider with genetic counseling.
View Article and Find Full Text PDFCorrection: Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements.
Ther Innov Regul Sci
January 2025
RTI International, Research Triangle Park, NC, 27709, USA.
Compounded glucagon-like peptide-1 receptor agonists for weight loss: the direct-to-consumer market in Colorado.
J Pharm Policy Pract
December 2024
Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Background: High prices and other access barriers have contributed to the rise of a market for compounded glucagon-like peptide-1 receptor agonists for weight loss in the United States. This market has not been systematically studied. We conducted a pilot study to assess the prevalence, characteristics, and advertising content of direct-to-consumer providers of compounded glucagon-like peptide-1 products for weight loss in Colorado.
View Article and Find Full Text PDFPharmacogenomics in psychiatry: Practice recommendations from an Asian perspective (2024).
Ann Acad Med Singap
December 2024
Institute of Mental Health, Singapore.
Introduction: Pharmacogenomic testing in psychiatry is an emerging area with potential clinical application of guiding medication choice and dosing. Interest has been fanned by commercial pharmacogenomic providers who have commonly marketed combinatorial panels that are direct-to-consumer. However, this has not been adopted widely due to a combination of barriers that include a varying evidence base, clinician and patient familiarity and acceptance, uncertainty about cost-effectiveness, and regulatory requirements.
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