Senator Chuck Grassley's (R-Iowa) office announced that he met with Iowa Audiology President and CEO Dr Jason Aird to discuss the Food and Drug Administration’s (FDA) finalization of a key rule allowing hearing aids to be sold over-the-counter – a “bipartisan effort Grassley has led for over five years.”
The bipartisan “Delivering Over-the-Counter Hearing Aids Now Act” follows the FDA’s proposed rule implementing over-the-counter hearing aids in October 2021, which was issued more than a year after the statutory deadline and over four years after the law’s passage.
Eargo, Inc (Nasdaq: EAR), a medical device company on a mission to improve the quality of life of people with hearing loss, announced the submission of public comments to the Food and Drug Administration (FDA) concerning its proposed rule to create a new regulatory category of over the counter (OTC) hearing aids.
To ensure patient safety, the proposed rule addresses maximum output limits and includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits, frequency bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids. As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”
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Starkey announced the launch of Listen Carefully, an initiative aimed at “bridging the conversation between hearing healthcare providers and lawmakers in Washington, DC.”
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An opinion article published on the data intelligence company Morning Consult’s website by Starkey President Brandon Sawalich discusses some “misconceptions about hearing aids” following President Biden’s recent executive order on competition.
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In an article recently published on the “Forbes” website, Starkey CEO Brandon Sawalich discusses the three guiding principles he follows with regard to the hearing care industry and the company’s dedication to providing people with better hearing
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On July 9, 2021, President Biden unveiled an executive order unveiling 72 initiatives that included, among other things, plans to allow hearing aids to be sold over the counter at pharmacies.
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According to “NPR,” the orders includes plans to allow hearing aids to be sold over the counter at pharmacies, much like Obama administration efforts that strived to make hearing aids less like pricy medical devices and as easy to purchase as reading glasses.
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The US Attorney’s Office for the Eastern District of Virginia announced on April 16 that it will be providing a Dear Colleague Letter reminding community partners that are involved in the COVID-19 pandemic response that the “Americans with Disabilities Act” applies to their services.
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Akouos, Inc announced that the US Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss.
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The action extends a moratorium preventing reductions in reimbursement for audiology and speech-language pathology services, which were scheduled for implementation on April 1, according to ASHA.
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The mass tort case against the Maplewood, Minnesota-based 3M from claimants alleging that its earplugs were “knowingly defective” and caused them to have hearing loss and tinnitus, will begin March 29, according to an article in the ‘Star Tribune.’
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The final recommendation—unchanged from the September version—concludes that there is insufficient evidence to recommend screening by doctors for hearing loss in asymptomatic adults aged 50 or older.
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An experimental 3D device used to treat hearing loss was recently approved by the FDA to treat an elderly man’s rare hearing loss, according to an article on the “Nextgov” website.
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Managed care is substantially growing in depth and breadth every year. Telehealth, OTC, the current pandemic, and other factors significantly impact the modern hearing care office in tandem with managed care. Therefore, as we evaluate, select and participate in managed care, we must seek and select the opportunities which best meet the goals and needs of the modern hearing care office.
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Under S-2441, the Deaf and Hard of Hearing Advisory Council’s membership will include new public members, including a parent of a child who is deaf or hard of hearing and has special needs, and a person who is deaf-blind.
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Gentamicin is used in US hospitals to treat a variety of bacterial infections, including infections in newborns and in other susceptible patients, such as those with cystic fibrosis. Yet researchers estimate that up to 20% of patients who are treated with it experience some degree of irreversible hearing loss.
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