Neuromod Devices has achieved both Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (MDR) certification, enabling expanded global availability of its Lenire tinnitus treatment device in Europe, Canada, Australia, and beyond.
Sens Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass) released the findings of their new bipartisan investigative report: Loud and Clear: Why Americans Want Effective and Affordable Over-the-Counter Hearing Aids – and How Powerful Special Interests are Trying to Undermine Them.
The Healthcare Equality Network (HEN)—a group advocating for equal, quality access to healthcare for Black Americans—recently wrote a letter to the Food and Drug Administration (FDA) proposing changes to the OTC Hearing Aid Rule.
The US Department of Justice (DOJ) and Kaiser Foundation Health Plan of Washington (KFHPW), resolved allegations from several complainants that it repeatedly failed to provide interpreters to patients who are deaf or deaf-blind, in violation of the “Americans with Disabilities Act (ADA),” announced US Attorney Nicholas W. Brown.
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The 114-page rules document published today in the Federal Register covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that could affect the industry and state-wide hearing aid dispensing.
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Starkey President and CEO Brandon Sawalich has issued a statement regarding the recent proposed ruling by the Federal Food and Drug Administration (FDA) outlining a new category of hearing aids that can be sold over the counter (OTC).
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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 As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”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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