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In Case You Missed It

Read the latest news, research updates and trends in audiology and hearing care. Post comments and share with your colleagues!

Monday, October 10, 2022

October Is National Audiology Awareness Month. In recognition of all that you do for your patients, The Hearing Journal Podcast brings you a special edition covering the FDA final rule on over-the-counter (OTC) hearing aids. This 4-part series shares important information on the changing hearing aid landscape, what it means for you, and how you can help secure audiology's future. Listen now.

Part 1: An Overview of OTC Devices
Part 1 - Bray Akbari Graphic for Social Media.pngPart 1 of our series interviews Victor Bray, PhD, and David Akbari, AuD, on a review of the FDA final rule and how it defines an OTC device.

Dr. Bray is an Associate Professor of Audiology at Salus University and the Past President of the Academy of Doctors of Audiology. Dr. Ackbari is the Senior Medical Science, Clinical and Regulatory Affairs Liaison at Intricon Corporation and serves as the current Chairman of the ANSI/ASA S3 WG48 working group that develops and maintains standards for the objective measurement of hearing aids.

“In my opinion, audiologists have an historic and unprecedented opportunity to reimagine the service delivery model that we use," said Ackbari.

Part 2: The New Category of Prescription Hearing Aids
Part 2 - Spoor Graphic for Social Media.pngPart 2 of our series interviews Alicia Spoor, AuD, on the creation of a new category of prescription hearing aids and the need for all states to review their licensure laws.

Dr. Spoor is the owner of Designer Audiology in Highland, Maryland. She serves as the Advocacy Chair for the Academy of Doctors of Audiology and is the Legislative Chair for the Maryland Academy of Audiology. She is also Past President of both organizations.

“You have to take action. If you don't agree with something that the associations and organizations do, you need to stop being a member because that gives them credit when they speak on your behalf. You need to stop paying dues, going to conventions, and being certified by those organizations," said Spoor. “Then, you need to find those people that do believe what you believe at the association and organization level. That's where you become a member, you attend their conferences, and you donate your time, talent, and treasure to their committees' advocacy funds and more."

Part 3: The Outlook Among the Obstacles
Part 3 - Czuhajewski Graphic for Social Media.pngPart 3 of our series interviews Stephanie Czuhajewski, MPH, CFE, on the current and potential obstacles audiologists face due to the FDA final rule.

Stephanie Czuhajewski is the Executive Director of the Academy of Doctors of Audiology. She has two decades of nonprofit leadership experience, with a focus on outreach and stakeholder relations.

“The entire health care landscape is changing, not just in the area of audiology," said Czuhajewski. “And it's increasingly important to be able to measure outcomes as a means of measuring value."

Part 4: A Call to Action
Part 4 of our series interviews Kristin Davis, AuD, on how audiologists can spring into action and look forward to a positive future with new opportunities for the profession.

Part 4 - Davis Graphic for Social Media.pngDr. Davis is the owner of Davis Audiology, which includes three successful practices throughout South Carolina. In 2017, she was co-awarded the Academy of Doctors of Audiology's Craig W. Johnson Audiology Advocate Award. She currently serves as President of the ADA Board of Directors.

“Think about it as a time of great change and also as a time to create the future that we want," said Davis. “We just have to be actively involved in it."

​Listen now!

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Friday, September 23, 2022

The findings of a National Institutes of Health (NIH) study reveal a specific network of proteins capable of hearing restoration in zebrafish. National Human Genome Research Institute (NHGRI) scientists who led the study theorize that this discovery may lead to future treatment options for hearing loss in humans. The study was published in Cell Genomics this August. 

The study identified two families of transcription factorsSox and Six transcription factorsthat together activate hair cell regeneration.

Hair cell loss can't be replaced in humans, but in several animals, such as zebrafish, hearing can be restored after injury by hair cell regeneration. Scientists hope to gain valuable insights about regeneration by investigating the regenerative properties of zebrafish hair cells.

Humans and zebrafish share more than 70% of their genes, which offers hope that the recent findings in zebrafish could one day be translated to humans.

“Humans and other mammals are born with a set number of hair cells that are slowly lost through aging and trauma. However some animals, such as zebrafish, can regenerate hair cells and recover hearing after injury," said Shawn Burgess, PhD, investigator in the NHGRI Translational and Functional Genomics Branch. “How and why regeneration happens in these animals remain a mystery that many scientists would like to unravel." Burgess co-led the study with researchers from the National Library of Medicine's National Center for Biotechnology Information.

Learn more about this ground-breaking scientific discovery.

Monday, September 12, 2022

In Case You Missed It.PNG
Portrayals of individuals with hearing loss have become a trend in recent films and TV shows. Characters with hearing loss have recently appeared in titles such as “A Star is Born," “Sound of Metal," “CODA," “El Deafo," and Marvel Studios' “Hawkeye."

Coauthors Dr. Alexander Chern, a resident physician in otolaryngology-head & neck surgery at New York-Presbyterian Hospital (Columbia and Weill Cornell), and Michael W. Denham, a fourth-year medical student at Columbia University's Vagelos College of Physicians & Surgeons, highlight this connection in their column “Hollywood Helps Fight the Stigma of Hearing Loss," which appears in the September 2022 issue​ of The Hearing Journal.

“Children often look to superheroes as role models," write the coauthors, “and the entertainment industry can play a valuable public health role by giving children with deafness more figures to look up to."

Positive portrayals of hearing loss in popular TV shows and movies can have a big impact on pediatric patients. Audiologists should embrace this trend as a helpful tool when looking for ways to care for both the physical and emotional health of pediatric patients.

Read the full story in our In Case You Missed It column.​

Thursday, September 1, 2022

​On August 16, 2022, the U.S. FDA issued a final rule establishing a new category of over-the-counter (OTC) hearing aids. Read the final rule here. Consumers with perceived mild-to-moderate hearing loss may purchase hearing aids from physical and online retailers without a medical exam, prescription, or audiologist fitting. The FDA says the goal of this final rule is to increase access to hearing aids by lowering the cost to obtain hearing aids.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions," said FDA Commissioner Robert M. Califf, M.D. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online."   

The new OTC hearing aid category only applies to certain air-conduction hearing aids for use by patients 18 years or older with mild-to-moderate hearing impairment. All other hearing aids that do not meet these criteria will still require prescriptions.

The impetus for the final rule came back in 2017 when Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids. The law was finally implemented last month. OTC hearing aids may become available in retail stores and pharmacies as early as mid-October, which is when the final rule takes effect.

After a proposed rule was issued on October 20, 2021, the FDA reviewed more than 1,000 public comments from a mix of consumers, professional associations, hearing aid manufacturers, public health organizations, advocacy groups, members of Congress, state agencies, and other stakeholders. The final rule includes several revisions from the original proposed rule to better ensure safety and effectiveness of OTC hearing aids, such as lowering the maximum sound output, revising the insertion depth limit in the ear canal, requiring user-adjustable volume control, and simplifying device labeling for ease of use. The new OTC category repeals the traditional conditions for hearing aid sale, such as the prescription requirement.

The FDA has also issued the Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the differences between hearing aids, which are medical devices, and PSAPs, consumer products that help people with normal hearing amplify sounds.  

The final rule goes into effect 60 days after publication in the Federal Register. Hearing aid manufactures who sold devices prior to the final rule's effective date must comply with the new regulations within 240 days after the final rule's publication. Manufacturers who have not yet sold devices must comply with the final rule before selling and marketing their new devices. 


Thursday, August 25, 2022

2022_BarbieFashionistas.jpg

Barbie's first doll with hearing aids, on sale from June 2022. Photo courtesy of Mattel, Inc.


This June, Barbie, the 63-year-old American doll maker, released a new line of dolls as part of the company's continuous initiative to offer more diversity in its products. Among the new set of dolls is the first ever Barbie with hearing aids.

Mattel's Global Head of Barbie Dolls, Lisa McKnight, said in a press statement that the new line will help kids "see themselves reflected."

Barbie enlisted the expertise of Dr. Jen Richardson, a leading practitioner in educational audiology, to help accurately design a behind-the-ear device for the doll.

"I'm beyond thrilled for my young patients to see and play with a doll who looks like them," said Richardson in a press release.

Barbie hopes the ponytailed doll with a hot pink hearing aid inspires those who have experienced hearing loss.

McKnight added that children should also be encouraged to play with dolls that don't resemble them to "understand and celebrate the importance of inclusion."