Category: Regulation

Regulation

APSO Opens Audiology Assistant Standard for Public Review and Comment

The Audiology Practice Standards Organization is inviting US audiologists to review and comment on a proposed national standard for audiology assistants through November 6, 2026.

FDA Formally Classifies Active Noise Attenuation Systems for Infant Incubators as Class II Devices
IAHA Establishes Global Working Group to Advance Hearing Accessibility Standards
Federal Judge Blocks Key Portion of Student Loan Rule Affecting Audiology Students
Audiology Australia Enhances Accreditation Pathways for Audiologists
Bipartisan CVTA Act Reintroduced to Modernize Digital Accessibility Rules for People With Disabilities
Audiology Australia Applauds Regulation Under Ahpra

Regulation

Neuromod Regulatory Approvals to Improve Lenire Global Availability

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.

Regulation

Sens Grassley and Warren Release OTC Hearing Aid Report

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.

Healthcare Equality Network Requests Changes to Proposed OTC Hearing Aid Rule

by Stefani Kim | Feb 15, 2022 | Organizations, Regulation | 0

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.

Sens. Grassley, Warren Support FDA Rule on OTC Hearing Aids

by Stefani Kim | Jan 27, 2022 | Legislation, Regulation | 0

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.

Starkey Releases Statement Addressing Biden’s Competition Council Announcement

by Stefani Kim | Jan 26, 2022 | Blogs, Legislation, Regulation | 0

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.

Eargo Supports Proposed Rule for OTC Hearing Aids

by Stefani Kim | Jan 25, 2022 | Legislation, Regulation | 1

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.

HLAA Files Comments to FDA for OTC Hearing Aid Rule

by Stefani Kim | Jan 21, 2022 | Legislation, Organizations, Regulation | 0

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.

NAAG Urges FDA to Preserve State Regulation of OTC Hearing Aids

by Stefani Kim | Jan 19, 2022 | Legislation, Regulation | 0

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.

Justice Department Settles with Hospital Over ‘ADA’ Complaint

by Stefani Kim | Jan 6, 2022 | Legislation, Regulation | 0

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.

US DOJ and KFHPW Settle Claim Related to ‘ADA Act’

by Stefani Kim | Oct 21, 2021 | Industry News, Regulation | 0

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.

FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC

by Karl | Oct 20, 2021 | Over the Counter, Regulation | 1

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.

Starkey Issues Statement On FDA Proposed OTC Ruling

by Stefani Kim | Oct 19, 2021 | Industry News, Regulation | 0

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).

FDA Issues Proposed OTC Hearing Aid Rules

by Karl | Oct 19, 2021 | Over the Counter, Regulation | 2

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).”