[Ohio-Talk] Fwd: For Those Of Us With Multiple Disabilities

[Suzanne Turner]

Sent from my iPhone

Begin forwarded message:

> From: Maggie Stringer via Ohio-Talk <ohio-talk at nfbnet.org>
> Date: October 27, 2021 at 9:05:13 AM EDT
> To: NFB of Ohio Announcement and Discussion List <Ohio-talk at nfbnet.org>
> Cc: Maggie Stringer <ravensfan784 at gmail.com>
> Subject: [Ohio-Talk] For Those Of Us With Multiple Disabilities
> Reply-To: NFB of Ohio Announcement and Discussion List <ohio-talk at nfbnet.org>
> 
> FDA Issues Proposed OTC Hearing Aid Rules
> Oct 19, 2021 | Over the Counter, Regulation |
> 
> The US Food and Drug Administration (FDA) has issued “a landmark proposal
> intended to improve access to and reduce the cost of hearing aid technology
> for millions of Americans,” according to the agency’s press release. The
> agency proposed a rule to establish a new category of over-the-counter
> (OTC) hearing aids that, when finalized, is designed to allow hearing aids
> within this category to be sold directly to consumers in stores or online
> without a medical exam or a fitting by a hearing care professional. The
> proposed rule is intended to help increase competition in the market while
> also ensuring the safety and effectiveness of OTC and prescription hearing
> aids, according to the agency.
> 
> The proposed rules are to be officially published in the Federal Registry
> October 20, 2021; a PDF is available here. This is to be followed by a
> 90-day commentary period at https://www.regulations.gov.
> 
> To ensure patient safety, the proposed rule addresses a maximum output
> (volume) limit for OTC hearing aids that would prevent injuries from
> overamplification of sound. In addition, the proposed rule includes certain
> device performance and design requirements, such as distortion control
> limits, self-generated noise limits, latency limits (how quickly an OTC
> hearing aid processes, amplifies and relays a sound), the range of
> frequencies that the device can reproduce and how uniformly the OTC hearing
> aid amplifies different frequencies over its 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.
> 
> To coincide with the proposed rule, the FDA also issued an updated draft
> guidance, Regulatory Requirements for Hearing Aid Devices and Personal
> Sound Amplification Products (PSAPs). The draft guidance describes hearing
> aids, PSAPs, their respective intended uses and regulatory requirements
> that apply to both types of products. The draft guidance is intended to
> provide further clarification regarding the differences between PSAPs,
> which help people with normal hearing amplify sounds, and hearing aids and
> to inform consumers that PSAPs are not considered OTC alternatives for
> hearing aids.
> 
> The proposed rule would also amend existing rules that apply to hearing
> aids for consistency with the new OTC category, repeal the conditions for
> sale for hearing aids and address state regulation of hearing aids. The OTC
> category, when finalized, would apply to certain air-conduction hearing
> aids intended for adults age 18 and older who have perceived mild to
> moderate hearing loss. Hearing aids for severe hearing loss or for users
> younger than age 18 would be prescription devices.
> 
> Today’s action follows President Biden’s July Executive Order on Promoting
> Competition in the American Economy, which called for the FDA to take steps
> to allow OTC hearing aids. This effort also builds on the Biden-Harris
> Administration’s goal of expanding access to high-quality health care and
> lowering medical care costs for the American public.
> 
> “Reducing health care costs for everyone in America is a top priority,”
> said Health and Human Services Secretary Xavier Becerra. “Today’s move by
> FDA takes us one step closer to the goal of making hearing aids more
> accessible and affordable for the tens of millions of people who experience
> mild to moderate hearing loss.”
> 
> Approximately 15% of American adults (37.5 million) age 18 and over report
> some trouble hearing. However, despite the high prevalence and public
> health impact of hearing loss, only about one-fifth of people who could
> benefit from a hearing aid use one. The proposed rule aims to address
> barriers to use, including cost, access, social stigma related to hearing
> loss, perceived value of the devices or certain state and federal
> regulations.
> 
> Many hearing aids can be expensive. The rule aims to facilitate innovation
> and increase competition by lowering the barriers to entry for new hearing
> aid manufacturers. Under the proposed rule, hearing aids would be sold over
> the counter in more traditional brick-and-mortar retail stores or online
> (rather than doctors’ offices or specialty retail outlets) and will likely
> be less expensive than those currently sold – giving consumers greater
> choice at lower prices.
> 
> The proposed rule implements a key provision of the Over-the-Counter
> Hearing Aid Act, as enacted in the FDA Reauthorization Act of 2017.
> President Biden’s Executive Order on Competition included a timeline for
> action, and the FDA has now issued the proposed rule ahead of that
> schedule.
> 
> “Hearing loss has a profound impact on daily communication, social
> interaction and the overall health and quality of life for millions of
> Americans,” said Acting FDA Commissioner Janet Woodcock, MD. “The FDA’s
> proposed rule represents a significant step toward helping ensure that
> adults with mild to moderate hearing loss have improved access to more
> affordable and innovative product options. The new regulatory category will
> provide the public with greater control over their hearing aid purchasing
> decisions at stores nationwide or online without the need for a
> professional hearing exam, fitting adjustment or a prescription.”
> 
> Source: FDA
> 
> Maggie Stringer
> Phone: (443) 750-0070
> Email: ravensfan784 at gmail.com
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