FDA Formally Classifies Active Noise Attenuation Systems for Infant Incubators as Class II Devices
The regulatory action clears a pathway for future manufacturers to bring noise-canceling incubator systems to market through a less burdensome route.
Category: Regulation
Regulation
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Regulation
Latest
Know the Facts: Charging Medicaid Patients
It is critical that audiologists and hearing instrument specialists understand regulations for charging for and delivering services or items to patients with Medicaid coverage.
Regulation
Latest
Eargo, DOJ Reach Settlement on Reimbursement Investigation
In line with the Company’s priority to regain insurance coverage of Eargo for government employees under the FEHB program, the Company is focused on enhancing its compliance and risk management processes with respect to its operations in the healthcare industry and hiring additional qualified personnel and specialized consulting resources before submitting any further claims.
Sens. Grassley, Warren Support FDA Rule on OTC Hearing Aids
In a letter to US Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) expressed their support for key provisions in the FDA’s proposed rule for regulating over-the-counter (OTC) hearing aids.
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Starkey Releases Statement Addressing Biden’s Competition Council Announcement
A statement from Starkey President Brandon Sawalich addresses President Biden’s announcement about the White House Competition Council, which was established by the July 2021 Promoting Competition in the American Economy executive order advancing US economic competition.
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Eargo Supports Proposed Rule for OTC Hearing Aids
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.
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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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