Devices

Grassley, Warren Bill to Speed OTC Hearing Aid

Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are ratcheting up pressure on FDA to issue its promised final rule allowing over-the-counter (OTC) hearing aids. The two lawmakers have just introduced their Delivering Over-the-Counter Hearing Aids Now Act to push the agency to finalize its 10/2021 proposed rule (see story) implementing OTC hearing aids.

Despite the pandemic and the snail’s-pace speed that rulemaking typically adopts at FDA, the senators are seeking quicker action on the regulatory move to unleash this new product category on the American public. They also are particularly troubled that the proposed rule was issued more than a year after the statutory deadline and over four years after a law’s passage to move certain hearing aids to OTC status. Their bill would apply additional pressure on FDA to finalize the rule within 30 days following enactment.

About 38 million Americans experience some hearing loss and many are deterred from seeking hearing aids due to their high cost and prescription-regulated process. Current hearing aids are not typically covered by private health insurance plans or traditional Medicare and can cost thousands of dollars. OTC hearing aids under the new law would be made available for mild to moderate hearing loss at a fraction of current costs, the lawmakers say.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome