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Thursday, December 8, 2016

The U.S. Food and Drug A​dministration said it would not enforce the requirement that people who are 18 years old and older to receive a medical evaluation or sign a waiver before purchasing hearing aids in a new guidance document published this week. The guidance, which is in effect immediately, applies to class I air-conduction and class II wireless air-conduction hearing aids, but not bone-conduction hearing aids. The FDA will continue to enforce the medical evaluation requirement for prospective hearing aid users under 18.​

The change came after the President's Council of Advisors on Science and Technology (PCAST) and a National Academies of Sciences, Engineering and Medicine (NAS) study cited FDA's "Condition for Sale" regulation as a potential barrier to the availability and accessibility of hearing aids. This new guidance closely follows NAS's recommendation that the medical evaluation requirement be removed for adults. FDA also intends to consider implementing PCAST's recommendation to "approve [a] class of hearing aids for over-the-counter (OTC) sale, without the requirement for consultation with a credentialed dispenser." 


Monday, November 28, 2016

Kazusaku Kamiya, MD, PhD, and his colleagues replicated cochlear cells that could potentially be used to replace faulty ones in patients with hearing loss caused by mutation of the Gap Junction Beta 2 (GJB2) gene (Stem Cell Reports. 2016). The researchers from Jutendo University in Tokyo, Japan, produced induced pluripotent stem cells aimed at correcting this inherited condition, which causes disruption of gap junction plaques in the cochlea and leads to profound sensorineural hearing loss. They demonstrated in a mouse model that the stem-cell-derived gap junction cells were functional for forming gap junction intercellular communication networks and transient ion species typical of the developing cochlea. The authors of the study hoped the in vitrol models could be used to develop inner-ear therapies and drug screening that target GJB2-related hearing loss.  

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Figure. Schematic of In Vitro iPSC Differentiation into Functional iCx26GJCs and Disease Model Cells for GJB2-Related Hearing Loss​

​Approximately one in 1,000 children has severe hearing loss at birth or during early childhood, with about half of the cases attributable to genetic causes. Mutation of the GJB2 gene is the most common cause of hereditary hearing loss worldwide and accounts for up to 50 percent of non-syndromic sensorineural hearing loss cases in some populations.


Friday, November 18, 2016

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Persistence Market Research (http://www.persistencemarketresearch.com/) forecasts the global hearing aids market will continue to grow and reach $10.91 billion by 2024, with North America leading with over $4,600 million in market revenue as the most attractive regional market. The third-platform research firm's report cites favorable reimbursement policies, gradual increase in disposable income, increasing global geriatric population, and an increase in the prevalence of hearing impairment as the driving forces behind the hearing aids market growth. ​

Among product types, behind-the-ear hearing aids are anticipated to be the highest contributor to the global market by the end of 2016, followed by receiver-in-the-ear hearing aids. Digital hearing aids, however, are expected to be the fastest growing and most attractive segment from now to 2024, generating over $2,700 million in estimates. For the end-user market, audiology clinics will dominate the highest percentage gain in market share over the next eight years.   


Monday, October 24, 2016

By Jackie Lam

​San Diego is not only the venue for this year's ADA convention but also a city filled with culture, history, and, surprisingly, beer! We at The Hearing Journal have hand-picked a few seasonal and ongoing activities for those who will be in town for AuDacity 2016 to check out.   

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1. San Diego Beer Week

The San Diego Brewers Guild will host its 10-day annual event to promote local craft beer as well as the city's robust brewing community from Nov. 4 to 13. San Diego is home to not only over 120 breweries but also the long-standing San Diego International Beer Festival, which featured a public tasting event and competition with beers from 28 states and 14 countries this year. The city has a reputation for brewing award-winning beers around the world. At this year's Craft Brewers Conference, also known as the "World Beer Cup," San Diego won 14 medals compared with the seven claimed by the U.K. and the 17 by Germany.

Each day of the San Diego Beer Week features a different event, with the most noteworthy being "The IPA Lounge," "Battle of the Guilds," and "Barrel Aged Day." There are some repetitions on the schedule but not many. Definitely check out the sessions you are interested in and plan ahead!

The general admission tickets in advance are $40 and $50 if you purchase on the day of. You can find out more about the event at the event's website.

2. Opening Day of the Bing Crosby Season

The Del Mar Thoroughbred Club is opening its fall season on Nov. 11 with a special program that harkens back to the old-school Hollywood glamor embodied by the race track's iconic founder Bing Crosby. On that day, participants are invited to enter the Star & Stripes Fashion Contest by dressing up in patriotic colors, as classic American icons like Rosie the Riveter and Lady Liberty, or as past or modern-day celebrities to win up to $3,000 in prizes.

In honor of Veterans Day, the club is hosting the Veterans Day Salute party in collaboration with the American Legion, a national nonprofit dedicated to serving wartime veterans. The celebration will feature a concert by country musician Coffey Anderson to support veterans-owned businesses. Proceeds from the party will go to Save Our Legion, the Semper Fi Fund, and other local military charities.

General admission to the Veterans Day Salute is $25, which includes admission to the party, the racetrack, and a barbeque, and to go to the concert only is $10. More information on tickets to the party and opening day in general is available on Del Mar's website.

3. Art: "DeLIMITations: A Survey of the 1821 United States-Mexico Border"

The current presidential race's focus on U.S.-Mexico border relations makes this exhibit at the Museum of Contemporary Art in San Diego especially timely. Artists David Taylor and Marcos Ramírez, who also goes by "ERRE," set out in 2014 to trace the original boundary between the two countries when Mexico first gained its independence from Spain in 1821, which, up to that point, existed only as a reference in historical documents. They installed 47 metal obelisk-shaped markers along the border and documented the whole journey from Brookings, OR, to Port Arthur, TX, in pictures and film, which is available for viewing at the exhibit.

Taylor told TIME that one of their goals for the project was to demonstrate the transitory and ephemeral nature of borders. Part of the exhibit is devoted to showcasing the changes brought about by historical events like the Mexican-American War and government treaties to the U.S.-Mexican frontiers. "We live with borders all the time and we depend on their permanence," Taylor said. "But in fact, history does not support them as static phenomena, they move around all the time."

DeLIMITations is on display until Nov. 27 at the downtown location of the Museum of Contemporary Art. Adults could enter at $10 and bring along those 25 or under for free. Other information about the museum can be found online.

4. Musical: "Miss You Like Hell"

Perhaps it's not surprising that Quiara Alegría Hudes, who won a Pulitzer Prize for her play "Water by the Spoonful" and co-wrote the Tony Award-winning musical "In the Heights" with Lin-Manuel Miranda from the smash hit "Hamilton," chose San Diego for the world premiere of her latest work. "Miss You Like Hell" tells the story of a Latina mother struggling to connect with her estranged daughter during a seven-day road trip before her potential deportation.

Hudes said parts of this original musical were inspired by what she witnessed at San Diego's Friendship Park on the U.S.-Mexico border in an interview with San Diego Magazine. "It was moving to see people who have been separated reunite at that location," Hudes said. "After that, we rewrote a scene that takes place there. We found big-time inspiration."

You could sample a song from "Miss You Like Hell" through a video made by Daphne Rubin-Vega, who portrays the lead character in the musical, of "Over my Shoulder" for the New York Times. The show runs with almost daily performances until Dec. 4 at the La Jolla Playhouse and tickets range from $25 to $73.

5. Gaslamp Quarter Architecture and History Tour

Gaslamp Quarter, listed as an historic district in the National Register of Historic Places, houses more than 90 Victorian buildings that have been standing in San Diego since the 1800's. Part of this 16-and-a-half-block strip was once a red light district named the "Stingaree," because sailors believed it was easier to get "stung" (robbed or abducted) in the area than it was in the surrounding ocean full of stingrays. Many historical buildings like Hotel Lester and the Spencer-Ogden Building were once home to sites of debauchery, such as brothels and opium dens, and bear the seedy history that used to characterize this part of town.

Aside from the preserved and restored buildings, Gaslamp Quarter today bears almost no resemblance to the Gaslamp Quarter in 1850. The Gaslamp Quarter Historical Foundation offers a glimpse into "the transformation of a desolate wasteland to the birth of 'New Town' that eventually merged with Old Town to become the city of San Diego" through 90-minute tours.

The groups depart on Thursdays and Saturdays from the Davis-Horton House the organization's headquarters and the oldest standing structure in downtown San Diego. Reservation is strongly recommended for these tours. For those who can't make it to the scheduled tours or prefer to travel at their own pace, a free self-guided audio tour of 30 major architectural landmarks in Gaslamp is available through the Geotourist app.

Photo credit: iStock/Ron Thomas


Monday, October 24, 2016

​By Toni Marie Bacala

The debate sparked by the 2015 PCAST report and recent NASEM recommendations finds yet another showground at the upcoming AuDacity 2016. In the much-anticipated panel, "Innovation & Disruptive Service Delivery Models," hearing health professionals and industry leaders will discuss the driving forces behind these groundbreaking reports, as well as the work of the Institute of Medicine (IOM) on accessible and affordable hearing health care.

"Regarding the drivers behind the activities at the national level, we will present an overview of the social, economic, physical, and psychological ramifications of untreated hearing loss and the increasing prevalence," explained Barbara Weinstein, PhD, who will serve as one of the panelists.

"The main goal is to provide audiologists with tools to continue to thrive in the face of the innovations thrust upon the profession," she stressed.

The two-part panel session will highlight issues of accessibility, affordability, and innovation—key concerns advanced in the PCAST and NASEM reports, which stirred opposing responses from audiologists and patients alike. Much of the lingering argument is on the recommendation for the FDA to create a separate over-the-counter category for "basic" hearing aids to boost access and expand the range of hearing aid options for those with mild to moderate hearing loss.

"We will discuss innovative ways to reach the people with mild hearing loss who do not avail themselves of our services which is an important and large customer base we should be reaching," said Dr. Weinstein on the panel's goal to address the different barriers to hearing aid access.

This discussion is in line with the NASEM recommendation to promote best practices and core competencies across the continuum of hearing health care, which includes examining, developing, and implementing quality metrics to improve patient outcomes.

Innovations in hearing screening and objective measurement will also be part of the agenda.

"We will recommend expanding the test battery to include screening for multi-morbidities linked to hearing loss such as fatigue, falls, cognitive decline," Dr. Weinstein explained to The Hearing Journal. On this note, she also confirmed that the panel will address the yet unproven direct link between hearing aid use and cognitive decline.

Improving patient-physician communication on hearing-related technology and services is also at the core of the NASEM recommendations.

"We will review how to administer screening tests of cognitive function and how to counsel [patients] about the outcome of the screen," Dr. Weinstein added. 

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