Audiology Australia Enhances Accreditation Pathways for Audiologists
The changes are designed to address workforce needs and create clearer routes to accreditation for both overseas-qualified and Australian audiologists.
Category: Regulation
Regulation
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Regulation
Latest
FDA Approves Fennec Pedmark Ototoxicity Drug
Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Fennec Pedmark (sodium thiosulfate injection) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors. This approval reportedly makes Pedmark “the first and only treatment approved by the FDA in this area of significant unmet medical need.”
Regulation
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APSO Releases Latest Hearing Aid Fitting Standard
The Audiology Practice Standards Organization (APSO) announced the release of its latest standard for public review and comment. This standard is titled “Hearing Aid Fitting Standard for Pediatric Patients” and describes the work that audiologists do to fit hearing aids on children.
HLAA Files Comments to FDA for OTC Hearing Aid Rule
The Hearing Loss Association of America (HLAA) announced that it filed comments to the Food and Drug Administration (FDA) on its proposed rule establishing Over-the-Counter (OTC) hearing aids. Once finalized by the FDA, consumers 18 and older with mild-to- moderate hearing loss will be able to purchase hearing aids at retail and online outlets.
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NAAG Urges FDA to Preserve State Regulation of OTC Hearing Aids
The National Association of Attorneys General (NAAG) cautions that OTC hearing aid rules currently under review by the FDA may unintentionally hinder or repeal important consumer protection authorities, undermining states’ ability to ensure safe and affordable access to hearing aids. Currently, all 50 states have hearing professional licensing requirements and many have important protections for hearing aid consumers, including advertising restrictions, as well as mandatory warrantees and returns.
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Justice Department Settles with Hospital Over ‘ADA’ Complaint
The settlement resolves a complaint by a deaf patient who alleged that despite her requests for an American Sign Language (ASL) interpreter for her labor and delivery, Advent failed to provide an interpreter or any other communication aid or service.
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US DOJ and KFHPW Settle Claim Related to ‘ADA Act’
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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FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC
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 Issues Statement On FDA Proposed OTC Ruling
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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FDA Issues Proposed OTC Hearing Aid Rules
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 Launches ‘Listen Carefully’ Initiative
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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Brandon Sawalich Discusses Impact of Biden Executive Order on Morning Consult
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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Brandon Sawalich Writes ‘Forbes’ Article on Leadership
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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Starkey CEO Writes Letter to Biden Addressing ‘OTC Law’
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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Biden Executive Order Looks at Cost of Hearing Aids
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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‘ADA’ Requirements Still in Place During COVID-19
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 Receives FDA Designations for AK-OTOF
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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Bill Postponing Medicare Cuts Expected to Become Law
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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