Page 9 - Healthcare News July/August 2022

HydrafacialTM Haircuts Makeup Pedicures Bridal Lash Extensions Spa Packages
Esthetics Balayage Massage Gel Nails Dermaplaning
56 Southwick Rd • Westfield, MA 01085 • (413)568-9000 • www.pufferdayspa.com
LOOKING TO HIRE SKILLED PERSONNEL?
THEY’RE READING THIS.
Connect to More Candidates in Print and Online.
Advertise management, administrative, clinical and other job openings in Healthcare News, and reach the audience you desire.
PUBLICATION NAMEPLATE
PUBLICATION NAMEPLATE B&W
Call Cecille Youmans
413.781.8600 ext. 112
youmans@businesswest.com
JULY/AUGUST 2022 WWW.HEALTHCARENEWS.COM 9
EYE & EAR CONT’D “represents a significant milestone in making hearing
aids more cost-effective and accessible.”
Biden agreed. “For millions of Americans, hearing
aids and the doctor’s visit to get them prescribed are
too expensive. In the executive order I issued last year “ to increase competition in key industries and lower
Untreated hearing loss can lead
to isolation, and it has been associated with serious conditions such as depression, anxiety, low self-esteem, dementia, reduced mobility, and falls. Yet only one in four adults who could benefit from hearing aids has ever used them.”
costs, I called on the FDA to finally make hearing
aids available over the counter,” the president said. “This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and well-being.”
While individuals with permanent hearing impair- ment can use hearing aids to help make speech and
sounds louder, improving the ability to communicate effectively with others, many hearing aids can be expensive, the FDA noted. The final rule aims to stim- ulate competition and facilitate the sale of safe and ef- fective OTC hearing aids in traditional retail stores or online nationwide, allowing consumers with hearing
loss improved access to devices that meet their needs and are less expensive than current options.
According to the National Institute on Deafness and Other Communication Disorders, “hearing loss significantly affects quality of life for tens of millions of adults in the United States and contributes to high healthcare costs. Untreated hearing loss can lead
to isolation, and it has been associated with serious conditions such as depression, anxiety, low self-es- teem, dementia, reduced mobility, and falls. Yet only one in four adults who could benefit from hearing aids has ever used them. Making hearing healthcare more accessible and affordable is a public-health priority, especially as the number of older adults in the U.S. continues to grow.”
FDA Commissioner Dr. Robert Califf agreed, calling hearing loss and hearing-aid access “a critical
public-health issue,” one that hampers the ability of millions of Americans to effectively communicate in their daily social interactions.
“Establishing this new regulatory category will allow people with perceived mild to moderate hear- ing loss to have convenient access to an array of safe, effective, and affordable hearing aids from their neighborhood store or online,” he added.
The OTC category established in this final rule ap-
plies to certain air-conduction hearing aids intended for adults (age 18 and over) who have perceived mild to moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are still prescription devices.
Listening to Advice
The FDA finalized the rule after receiving and reviewing more than 1,000 public comments last fall, submitted by consumers, professional associations, hearing-aid manufacturers, public-health organiza- tions and advocacy groups, members of Congress, state agencies, and other stakeholders.
In response to public comments and to assure
the safety and effectiveness of OTC hearing aids — which, again, users will typically be handling without the instructions of a doctor — the final rule incorpo- rates several changes from the initial proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification
of sound, revising the insertion depth limit in the
ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood. The final rule also in- cludes performance specifications and device design requirements specific to OTC hearing aids.
The American Speech-Language-Hearing Assoc. (ASHA) is currently conducting a detailed analysis
LOGO COLOR
LOGO B&W