Tag: IHS

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OTC and AAA, ADA, IHS, and ASHA: Now That We’re All on the Same Page…

It’s time to clearly distinguish professional service from self-service by showing why licensed hearing care professionals can make a huge difference in hearing aid outcomes. Let’s commit to getting consumers a list of essentials by creating a voluntary standard protocol for every licensed professional who dispenses hearing aids. Let’s spell out what consumers should expect. And then let’s promote the hell out of it.

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OTC Hearing Aid Consensus Statement Published by AAA, ADA, IHS, and ASHA

The unprecedented consensus statement from four national hearing care professional organizations recommends the new FDA classification be called “Self-fit OTC hearing devices.” The paper recommends the new class be intended for mild-to-moderate hearing losses of 26-55 dB HL (26 max HFA-FOG/110 dB max output), offer input compression and volume controls, contain clear and easy-to-understand labeling both on the inside and outside of the packaging, and require at last one 510(k) filing for initial FDA approval to ensure the basic safety and efficacy of the device.

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NASEM Committee Looks at Regulations for OTC Hearing Devices

The June 9 Dissemination Meeting featured a wide menu of possible regulations for a new OTC category of hearing devices, and the meeting concentrated on safety and quality control, as well as packaging and labeling requirements. The NASEM meeting’s proposals are not part of the FDA’s formal rule-making process, but they could serve as a starting point for considerations by FDA and discussions with stakeholders in hearing hearing healthcare when formulating a possible new OTC hearing device category.

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Over-the-Counter Hearing Aid Act of 2017 Introduced in Congress

The Over-the-Counter Hearing Aid Act of 2017 was introduced Monday, March 20. The reintroduced legislation is designed to make hearing aids for those with mild-to-moderate hearing loss available over the counter (OTC), and require the FDA to write regulations ensuring the new OTC category meets the same high standards for safety, consumer labeling, and manufacturing protections as all medical devices, providing consumers the option of an FDA-regulated device at lower cost.

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Audiology Advocates React to Senate Passing Veterans Mobility Safety Act

The US Senate has unanimously passed the Veterans Mobility Safety Act, a bill passed by the US House of Representatives in September 2016. It is expected to be signed into law by the President. The bill requires that hearing aid specialists provide services within their scope of practice related to fitting and dispensing hearing aids, under a treatment plan of an audiologist.

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'Fit to Serve' Bill (HR 3471) Passes with Revised Language Advocated by Audiology Organizations

Although HR 3471—the centerpiece of the International Hearing Society’s ‘Fit to Serve’ campaign—has passed in the US House of Representatives, revisions have been made to limit the role of hearing aid dispensers in the VA to that of the fitting and dispensing of hearing aids only, according to the major audiology professional organizations.

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‘Fit to Serve’ Bill (HR 3471) Passes with Revised Language Advocated by Audiology Organizations

Although HR 3471—the centerpiece of the International Hearing Society’s ‘Fit to Serve’ campaign—has passed in the US House of Representatives, revisions have been made to limit the role of hearing aid dispensers in the VA to that of the fitting and dispensing of hearing aids only, according to the major audiology professional organizations.

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