Senators Grassley and Warren Request Update on ‘OTC Hearing Aid Act’
Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Elizabeth Warren (D-Mass) are...
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Search Results for: otc
Blog: OTC Hearing Aid Proposed Regulations Likely Delayed Until at Least Q1 2020
The proposed regulations for a new class of over-the-counter (OTC) hearing aids—which had previously been slated for release by the FDA this month—will now likely to be released sometime in the first quarter of 2020.
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CBS News’ ‘Sunday Morning’ Segment Discusses OTC Hearing Aids
In a segment on CBS News’ ‘Sunday Morning’ show, contributor and Yahoo Finance tech critic David Pogue examines the low rate of hearing aid adoption in comparison to the percentage of people over 70 with hearing difficulties.
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IntriCon Provides Insights into OTC Hearing Aid Market; Experiences Some Headwinds in Q2 2019
The company is bullish on the prospects of the upcoming OTC hearing device regulations from FDA, which it anticipates being issued this November and implemented in mid-2020. In his comments to investors, IntriCon CEO Mark Gorder was also optimistic that the new OTC hearing device regulations would be more liberal relative to the amount of allowable gain and for whom the devices might be intended.
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MarkeTrak 10: Hearing Aids in an Era of Disruption and DTC/OTC Devices
On the eve of major changes in the regulations governing the distribution of hearing aids in the United States, including the new upcoming class of over-the-counter (OTC) hearing devices, MT10 looks at consumers’ perceptions about hearing aids and personal sound amplification products (PSAPs)—as well as their attitudes about OTC devices and do-it-yourself hearing care.
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Preparing for OTC Hearing Aids
Unless you’ve been locked in your soundbooth for the past three years, you’re probably well aware that a new class of over-the-counter (OTC) hearing aids will get the green light from the US Food and Drug Administration (FDA) sometime around August 2020, with the notice of proposed rulemaking (NPRM) slated for this November.
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Preparing for OTC Hearing Aids
Unless you’ve been locked in your soundbooth for the past three years, you’re probably well aware that a new class of over-the-counter (OTC) hearing aids will get the green light from the US Food and Drug Administration (FDA) sometime around August 2020, with the notice of proposed rulemaking (NPRM) slated for this November.
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Blog: FDA to Issue First Proposed Rules on OTC Hearing Aids in November
It now appears the “OTC regulatory debate” could potentially follow the same general timeframe as the 2020 presidential race—starting with proposed rules by the FDA in November of this year.
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Mead Killion Adds to Humes’ Comments Regarding PSAP/OTC Findings
Mead Killion, PhD, provides his perspective on the audiograms used in two studies that look at the suitability of personal sound amplification products (PSAPS) for people with hearing loss in various delivery models.
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Letters: Hearing Loss Severity and OTC Hearing Aids: Larry Humes Comments on Article by Leavitt, Bentler & Flexer
Larry Humes, PhD, explains the reasoning behind why the vast majority of participants in his group’s recent study related to OTC hearing aids had near-normal or mild hearing loss, as pointed out by a December 2018 “Hearing Review” article by Ron Leavitt, Ruth Bentler, and Carole Flexer.
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Evaluating Select Personal Sound Amplifiers and a Consumer-Decision Model for OTC Amplification
OTC hearing devices are coming, but how should they function and for whom should they be recommended? Drs Ron Leavitt, Ruth Bentler, and Carol Flexer present six case studies showing that people with true moderate hearing loss may not be well served by what has been characterized as a “consumer-decides” model of care.
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OTC: Let’s Get on the Same Page!
Now that we’ve defined (at minimum) what an OTC hearing device should look like, maybe it’s time to start defining a minimal standard for what a professional hearing aid fitting should look like.
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After OTC, Focus Should Be on Clinical Hearing Services, Says ‘JAMA’ Article
Given that the Over-the-Counter (OTC) Hearing Aid Act of 2017 is now law and a new FDA class of OTC hearing aids will be established by the end of 2020, “efforts should now focus on ensuring that older adults also have access to affordable hearing care services,” write Nicholas Reed, Frank Lin, and Amber Willink, PhD, in the September 13 “JAMA Network.”
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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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HIA Endorses Recommendations on OTC Hearing Devices by Professional Organizations
The Hearing Industries Association (HIA) has announced its endorsement of the five recommendations made in the consensus paper by AAA, ADA, ASHA, and IHS titled, “Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness”.
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