Hearing industry calls Bose self-fit hearing aid study flawed in complaint to FDA | MedTech Dive

Dive Brief:

Dive Insight:

FDA granted Bose’s self-fit hearing aid a De Novo in 2018 based on clinical studies of 125 patients examining if the outcomes of self-fitting the device were comparable to professional fitting. The device is indicated direct-to-consumer sale to those over 18 without the assistance of an audiologist.

HIA’s letter to Srinivas Nandkumar, the branch chief of FDA’s Division of Ophthalmic and Ear, Nose, and Throat Devices, argues the Phase II clinical study “does not provide enough evidence of effectiveness of the self-fitting method given the study’s initial reliance on professionals for fitting.”

According to FDA’s decision summary, the two-arm study of 75 patients had three clinic visits alongside several weeks of use in the real world. During the first two visits, patients were fit professionally by audiologists before being assigned to a one-month field trial in a professional fit group or self-fit group.

During the third visit, patients were accessed using speech-in-noise tests and questionnaires about the benefit of the devices.

“This does not reflect the actual real-world experience,” HIA’s letter states. “As such, HIA has concerns the data the study relies upon may not accurately reflect the ability of treatment-naive hearing patients to adequately ‘self-fit’ without the assistance of a licensed hearing professional.”

Bose declined to elaborate on the specific concerns raised by HIA, pointing to FDA’s determination the device is safe and effective.

“Our submission to the FDA for the De Novo grant, which we received last fall, speaks for itself,” Bose spokesperson Joanne Berthiaume told MedTech Dive.

FDA declined to comment on the specific HIA letter but noted the De Novo pathway is intended to provide a path to market for medical devices when general and/or special controls can provide a reasonable assurance of safety and effectiveness.

“The Bose company submitted, and FDA granted, a request for De Novo classification,” an FDA spokesperson told MedTech Dive in an email. “These decisions are based on a benefit vs risk decision making that is outlined in our publicly available decision summary.”

HIA declined an interview with MedTech Dive, but its letter makes it clear it is attempting to influence over-the-counter hearing aid regulations under development.

HIA spent $30,000 during the second quarter lobbying Congress over the regulation of hearing aids and over-the-counter hearing aid devices. Brandon Sawalich, the chairman of the trade group’s board of directors, is also the president of Starkey Hearing Technologies, a hearing aid firm that also heavily lobbies the government to protect its bottom line.

The FDA Reauthorization Act of 2017 mandates the agency establish a category of over-the-counter hearing aids by August 2020. The agency plans to issue a proposed rule in November that is intended “to promote the availability of additional kinds of devices that address age-related hearing loss,” according to FDA’s spring regulatory plan.

This content was originally published here.

Dallas father, son get prison for $27M hearing-aid scam targeting American Airlines workers | Crime | Dallas News

A father and son from Dallas were sentenced to prison Wednesday after being convicted of fraud and identity theft in a $27 million scheme involving false hearing aid insurance claims submitted on behalf of American Airlines employees.

Terry Lynn Anderson, 69, received an eight-year sentence in federal prison and was ordered to pay nearly $13.7 million in restitution to Blue Cross and Blue Shield of Texas. 

He also must forfeit a 300-acre ranch in Valley Mills, three vehicles and more than $3.1 million seized from nine financial accounts.

His 38-year-old son, Rocky Freeland Anderson, was sentenced to seven years and ordered to pay more than $8.4 million to Blue Cross.

The duo was convicted last year on multiple counts of health care fraud and aggravated identity theft after a 10-day jury trial before U.S. Chief District Judge Barbara M. G. Lynn.

An FBI investigation determined the Andersons defrauded Blue Cross by submitting claims on behalf of Fort Worth-based American Airlines employees for hearing aids that were not needed and often never given to patients, U.S. Attorney Erin Nealy Cox said.  

The claims were submitted through Anderson Optical and Hearing Aid Center, a business owned by the Anderson family with locations in Arlington and Bedford.

“In flagrant disregard for the law, these defendants submitted claims for equipment they knew patients neither needed nor wanted, just to line their own pockets,” Cox said. “This sort of fraud impacts healthcare costs for patients who actually need coverage, and we will continue to prioritize these cases.”

The Andersons promised a free pair of high-end sunglasses or eyeglasses in exchange for free hearing tests, the investigation determined. After the tests, they told patients that they had slight to mild hearing loss and required them to sign an order for hearing aids before they received the free glasses. Hearing aids were promised to them at no cost, and the Andersons said their company would waive any copayments, coinsurance or deductibles. 

The father and son also offered patients $100 gift cards in exchange for referring family members and coworkers for free hearing tests, Cox said.

This content was originally published here.

In Memory Of Janice Elaine Starkey Collins | Sierra News Online

Janice Elaine Starkey Collins was born on June 14, 1941 in Fresno, California and went to be with our Lord Jesus on March 11, 2019.

Janice was born to Orval and June Starkey. She had six siblings: Victor, Margaret, Arthur, Carol, Chet, and Gayle. She is survived by her loving husband of 60 years Richard Collins, as well as sons Randy, Eddie and Tim, and daughter Misty. She also leaves behind grandchildren Nichole, Bethany, Travis, Brooke, Ashley, John, Amy and 11 great-grandchildren.

Janice met Richard, the love of her life, at Sierra High School in 1957. These high school sweethearts married January 31, 1959; they loved and cared for each other for 60 years.

Their first child, Rodney, passed away at five weeks of Sudden Infant Death Syndrome on October 6, 1959.

Janice worked as a chef at many restaurants in North Fork, Oakhurst, Coarsegold, and Bass Lake, prior to becoming Cafeteria Manager at North Fork School for 27 years, a job she loved. She cooked home-style breakfast and lunches for many children over the years.

Richard and Janice were members of Assembly of God Church for 20 years where they blessed their children with a Christian life.

Janice had several hobbies including crochet, crafts and making porcelain dolls. Her handmade dolls range in size from 1 inch to 5 feet 10 inches. She beautifully hand-painted and dressed them in her favorite styles.

Janice survived breast cancer for 29 years, as well as heart valve replacement and numerous strokes. She was a courageous and strong woman, physically and mentally. She was completely and unselfishly dedicated to her family. She cherished her husband, children, grandchildren, and great grandchildren; she was so happy when she was around family. Christmastime was her favorite time of year, and she was especially pleased when she and dad could spoil the children — it gave them such joy and happiness.

After retirement Janice took on another role of raising three of her great-grandchildren. She stayed very active with her great-grandchildren and gardening. She loved working in the yard planting flowers and pulling weeds; it was one of her main joys in life. Another joy was talking for hours on the phone with her siblings.

Janice was an amazing woman with many talents. She was strong in her morals, convictions and fairness. She was a loving and caring wife, mother, sister, grandmother, great-grandmother, mother in law and friend.

She will be missed and cherished for many years to come, when we talk of her and tell those stories we all have and hold in our hearts, so that she will live on for those in our family that will never get to know her.

This content was originally published here.

Bluetooth, AI and health tracking: hearing aids are smarter than ever

One in six people in the UK lives with hearing loss, 6.7 million of whom could benefit from a hearing aid. However, only around two million people in the UK use them. Assistive hearing technologies have progressed significantly in recent years, transforming the lives of many people who previously lived with a more limited range of sound available to them.

Retired NHS nurse and hearing aid user Helen Cherry says: “Whilst many digital aids have benefitted me, nothing prior to my smart hearing aids has been able to compare to the quality of sounds and the ability to self-manage and personalise the device to my needs in different environments. I instantly noted the crisp clarity and layering of the textured colours of sound. I feel like I hear in purple velvet-like sounds.”

Verdict Medical Devices takes a closer look at some of the life-altering innovations in hearing aid technology.

Audio streaming

Hearing aids of the past often limited the wearer’s access to music players, as earphones and hearing aids cannot be worn simultaneously. However, wireless technology makes it possible to connect Bluetooth-enabled audio devices like iPhones and smart TVs directly to a set of hearing aids.

The listening experience can be personalised, streaming audio to one or both hearing aids depending on the wearer’s preference. Multiple devices can be connected at a time, so the wearer can be comfortable watching the television knowing they’ll still be notified by their aids if they receive a phone call. The stream is typically operated via a mobile phone app, as many hearing aids are too small to accommodate external controls.

Smart home connectivity

The Internet of Things (IoT) is bringing digital connectivity to a growing list of household devices. Now, a software platform called IF This Then That (IFTTT) allows smart hearing aid users to connect their aids to IoT devices around their home, automating various aspects of their day-to-day lives.

Hearing aids like the Oticon Opn can use a wireless internet connection to sync up to various internet-enabled household devices such as a doorbell or fire alarm. This enables a sound such as a spoken notification or chime to be delivered through the hearing aids when these devices are triggered, giving users more independence.

This smart home connectivity is even possible with IoT-enabled coffee machines and home lighting systems. If a hearing aid user wants the coffee machine to come on when they switch on their aids in the morning, or for their bedroom lights to switch off when they turn off their aids at night, they can do so through IFTTT.

AI health monitoring

Smart hearing aid manufacturer Starkey has developed Livio AI, the first ever hearing aid to use integrated sensors and AI to monitor the user’s health.

Through an app called Thrive, Livio AI hearing aids use inertial sensors like accelerometers and gyroscopes to track the wearer’s physical and mental health for an overall daily wellness score. The aids track a combination of activity, steps and overall movement to provide a ‘Body’ score, while the hours of daily use, social engagement and active listening provide a ‘Brain’ score.

For hearing aid users who are elderly or otherwise prone to falls, these aids can also detect when a fall occurs through the sensors and send a text message to up to three emergency contacts. The aids use AI to detect what is and isn’t a normal range of motion for the user to avoid triggering false alarms. Users can also tap the aid to send a manual fall alert notification.

Starkey is working toward adding heart rate monitoring to Livio AI’s capabilities.

The post Bluetooth, AI and health tracking: hearing aids are smarter than ever appeared first on Verdict Medical Devices.

This content was originally published here.

Baby Girl Was Born Deaf And Finally Gets To Hear Mom Say ‘I Love You’ After Being Fitted For Hearing Aids

Baby Girl Was Born Deaf And Finally Gets To Hear Mom Say ‘I Love You’ After Being Fitted For Hearing Aids

Baby Charly’s parents grew concerned when their little girl didn’t respond to noises or vocal cues. The concerned parents took her into the doctor and requested a hearing test. The results showed that Charly was hearing-impaired. She would need to start wearing a hearing aid immediately. A hearing specialist molded a hearing aid specially for Charly’s ear. Once they turned it on, they had no idea she was going to have such a profound reaction.

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Children born with no hearing impairment get immersed in language from the moment they arrive. As people speak, these non-impaired children start to pick up that certain sounds have meaning.

Children born with a hearing loss don’t get this type of immersive experience as infants. They have difficulty developing language skills. That’s why most doctors recommend that infants with hearing loss be fitted with hearing aids as quickly as possible. 

The sooner an infant gets fitted with hearing aids, the sooner they start developing those critical language skills. Charly’s parents made it a priority to get her fitted immediately.

Waiting any longer would hinder Charly’s development. The hope was that the hearing aid would give the baby girl an avenue into the world of sound. Because she was so young, however, they didn’t know how well things would go.

They were in for an amazing surprise. As soon as the hearing aid went on, Charly’s face transformed. She got to hear her mother’s voice for the first time, bringing her to tears. As she heard more and more, the expressions on her face shows her emotions.

Of course, Charly cannot verbalize her feelings at a young age. But, everyone in the room could tell she started crying when she heard her mother for the first time. It’s going to take time for this baby girl to learn to talk and develop her listening skills.

But, the world is now her playground. Watch as Charly’s world opens up, and she makes that critical connection with her Mom. Try not to cry! Technology can truly do wondrous things.

What did you think of Charly’s reaction to this brand-new world of sound? Let us know and give your friends and family the chance to see it for themselves.

This content was originally published here.

Local man helps break stigma around wearing hearing aids; rewarded with new pair that’s the latest techLocal man helps break stigma around wearing hearing aids; rewarded with new pair that’s the latest tech

Local man helps break stigma around wearing hearing aids; rewarded with new pair that’s the latest tech

Danton Hyman, 22,  has helped break the stigma around hearing aids, and because of his advocacy in the community got an upgrade in technology donated by Starkey Hearing Technologies.

Columbia, S.C. (WOLO) — A local college athlete will soon be able to hear in a way he’s never done before, thanks to a new pair of high-tech hearing aids. Danton Hyman, 22,  has helped break the stigma around hearing aids, and because of his advocacy in the community got an upgrade in technology donated by Starkey Hearing Technologies.

Hyman has worn hearing aids since age 2. He’s a recent graduate of Newberry College, and played baseball for the school.

“They’re a part of me, they’re a part of my identity and it’s just who I am. I feel like I’d be different without them,” said Hyman. “My motto going through life is that never let anything stop you and you’re capable of doing anything, even though you’re wearing hearing aids.”

He’s been an advocate for people who are hearing impaired, and has helped inspire anyone who may be uncomfortable wearing the aids.

“I’ve been able to talk to other people and I’ve had people inspire me when I was growing up, and I’ve also been able to inspire other people by talking to them and people who are not as comfortable as I am wearing hearing aids,” said Hyman.

The president of Starkey Hearing Technologies heard about Hyman, and wanted to reward him for his impact in the community.

“He is a huge baseball fan, and came across Danton’s story, and reached out and really wanted to be a part of that awareness that Danton was bringing about,” said Kate Marr, Senior Sales Audiologist with Starkey.

Now, Hyman will have the newest technology to help him do the simple things like talk on the phone.

“I’m blown away. I’m really blown away, because I didn’t know– whoever would’ve thought that you can be wearing hearing aids and you talk to people through the phone. I mean, that is amazing,” said Hyman.

“The look on his face really said it all. It was like a light was switched on,” said Marr.

This content was originally published here.

This creative mom transforms kids’ hearing aids into superheroes to boost their confidence

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Hearing aids are a useful device for people who are diagnosed with certain degrees of deafness. However, we have to admit that when it comes to appearance, hearing aids clearly aren’t the winner. Kids, especially, feel embarrassed about wearing them because of the fear of looking different.

Sarah Ivermee from UK has a 4-year-old son named Freddie who was diagnosed as profoundly deaf in his right ear and moderately to severely deaf in his left ear when he was just 3 months old. The condition was caused by the cytomegalovirus that she acquired during her pregnancy.

Lucky for her, she didn’t have any problems with Freddie and his hearing aids – they were rarely off.

But eventually, the mother of two met other families whose children also use hearing aids, and she found that not all kids enjoy wearing them. Most youngsters think that they look plain and boring, and a lot of them were also embarrassed about wearing them because it made them look different.

A friend of theirs has a 9-year-old daughter who feels the same. Sarah happened to have some flowery stickers nail stickers lying around at their home, and she thought of giving them to the kid to decorate her aids.

The young girl absolutely loved the pretty results, and because of how simple of a solution it was, Sarah thought that there must be some kind of product in the market that did the same. But then, she learned that there was hardly anything out there that was ready to use and accessible, and that’s when an idea came.

After a whole lot of research and trial and error, Sarah finally launched Lugs in 2014, a company that sells custom-made kits to decorate hearing aids and cochlear implants.

The designs range from colorful flowers to popular superheroes, and it is guaranteed to  make children everywhere feel proud of sporting their hearing devices.

“I am so pleased every time my inbox pings and I receive a thank you email accompanied with pictures of children wearing Lugs on their hearing devices and loving them. Needless to say, our son Freddie reaps the most benefit from the business, as he gets to choose new designs every month, making all his hearing friends at school very jealous!” Sarah wrote in a blog post on Limping Chicken.

Check out the gallery below to see some of Lugs’ coolest designs.

This content was originally published here.

Program Offers Hearing Aids To Low Income Seniors | News/Talk 94.9 WSJM

A new program has been announced by the Berrien Community Foundation to give free hearing aids to low-income seniors. The foundation’s Lisa Cripps-Downey tells WSJM News the Starkey Hearing Foundation is expanding to Berrien County this year thanks to the Frederick S. Upton Foundation. As part of the Hear Now Mission, the BCF is working with Dr. Kasewurm’s Professional Hearing Services in St. Joseph to get these hearing aids to those in need.

“She’ll do the initial hearing exam, and then schedule them for a fitting, and then they would actually receive these brand new hearing aids at a hearing aid event on June 4,” Cripps-Downey said.

Cripps-Downey says the program is offering up to 120 hearing aids to seniors who meet the eligibility guidelines. A hearing aid can often cost thousands of dollars. Anyone who wants to learn more about the program can go to BerrienCommunity.org/HearNow or you can call the Berrien Community Foundation to find out more. The applications should be submitted by mid-May.

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Wearing hearing aid may help protect brain in later life — ScienceDaily

It builds on important research in recent years pulled together by the Lancet Commission on Dementia Prevention, Intervention and Care, through which hearing loss emerged as an important risk factor for dementia. This research suggests that wearing a hearing aid may mitigate that risk.

The research was conducted by the University of Exeter and King’s College London and is presented at the Alzheimer’s Association International Conference in LA. In the PROTECT online study of 25,000 people aged 50 or over.

The findings provide early evidence that encouraging people to wear an effective hearing aid may help to protect their brains and reduce their risk of dementia.

Both groups undertook annual cognitive tests over two years. After that time, the group who wore hearing aids performed better in measures assessing working memory and aspects of attention than those who did not. On one attention measure, people who wore hearing aids showed faster reaction times — in everyday terms, this is a reflection of concentration, for example, ‘straining to hear a sound’, ‘peering closely at an object of great interest’, ‘listening intently to someone speaking’.

PROTECT lead Dr Anne Corbett, from the University of Exeter, said: “Previous research has shown that hearing loss is linked to a loss of brain function, memory and an increased risk of dementia. Our work is one of the largest studies to look at the impact of wearing a hearing aid, and suggests that wearing a hearing aid could actually protect the brain. We now need more research and a clinical trial to test this and perhaps feed into policy to help keep people healthy in later life.”

Professor Clive Ballard, of the University of Exeter Medical School, said: “We know that we could reduce dementia risk by a third if we all took action from mid life. This research is part of an essential body of work to find out what really works to keep our brains healthy. This is an early finding and needs more investigation, yet it has exciting potential. The message here is that if you’re advised you need a hearing aid, find one that works for you. At the very least it will improve your hearing and it could help keep your brain sharp too.”

The poster is entitled ‘Use of Hearing Aids in Older Adults with Hearing Loss Is Associated with Improved Cognitive Trajectory’.

This content was originally published here.

Wearing hearing aid may help protect brain in later life – Neuroscience News

Summary: Wearing a hearing aid for age-related hearing loss may help to protect the brain against dementia, a new study finds. Researchers report those who wore hearing aids maintained better brain function over time than those who did not.

Source: University of Exeter

A new study has concluded that people who wear a hearing aid for age-related hearing problems maintain better brain function over time than those who do not.

It builds on important research in recent years pulled together by the Lancet Commission on Dementia Prevention, Intervention, and Care, through which hearing loss emerged as an important risk factor for dementia. This research suggests that wearing a hearing aid may mitigate that risk.

The research was conducted by the University of Exeter and King’s College London and is presented at the Alzheimer’s Association International Conference in LA. In the PROTECT online study of 25,000 people aged 50 or over.

The findings provide early evidence that encouraging people to wear an effective hearing aid may help to protect their brains and reduce their risk of dementia.

Both groups undertook annual cognitive tests over two years. After that time, the group who wore hearing aids performed better in measures assessing working memory and aspects of attention than those who did not. On one attention measure, people who wore hearing aids showed faster reaction times – in everyday terms, this is a reflection of concentration, for example, ‘straining to hear a sound’, ‘peering closely at an object of great interest’, ‘listening intently to someone speaking’.

The findings provide early evidence that encouraging people to wear an effective hearing aid may help to protect their brains and reduce their risk of dementia. The image is in the public domain.

PROTECT lead Dr. Anne Corbett, from the University of Exeter, said: “Previous research has shown that hearing loss is linked to a loss of brain function, memory and an increased risk of dementia. Our work is one of the largest studies to look at the impact of wearing a hearing aid and suggests that wearing a hearing aid could actually protect the brain. We now need more research and a clinical trial to test this and perhaps feed into policy to help keep people healthy in later life.”

Professor Clive Ballard, of the University of Exeter Medical School, said: “We know that we could reduce dementia risk by a third if we all took action from mid-life. This research is part of an essential body of work to find out what really works to keep our brains healthy. This is an early finding and needs more investigation, yet it has exciting potential. The message here is that if you’re advised you need a hearing aid, find one that works for you. At the very least it will improve your hearing and it could help keep your brain sharp too.”

About this neuroscience research article

Source:
University of Exeter
Media Contacts:
Louise Vennells – University of Exeter
Image Source:
The image is in the public domain.

Original Research: The findings will be presented at Alzheimer’s Association International Conference 2019 in Los Angeles, California.

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Zak Starkey Launches New Reggae Label Trojan Jamaica With Compilation LP ‘Red, Gold, Green & Blue’ (ALBUM REVIEW)

Trojan Jamaica is a brand new label co-founded by Zak Starkey and Sharna “Sshh” Liguz whose first release is the compilation album Red, Gold, Green & Blue. That blue is added to the title of the record as Starkey and Liguz worked with reggae legends to record some classic blues numbers in their own style. The end result is a mixed bag of tunes as the island vibe and broken-hearted blues don’t always synch, however when they do, the results are rollicking. 

All efforts have a jam session vibe and the best songs find the impressive house band of Starkey (guitar), Robbie Shakespeare (bass), Sly Dunbar (drums), Tony Chin (guitar), Cyril Neville (drums), Michael Rendall (keyboards, organ) and Leroy “Horsemouth” Wallace (drums, organ) pairing with the singers expertly, such as on the slinky, sexy interpretation of Screaming Jay Hawkins “I Put A Spell On You” sung by Mykal Rose. Another exuberant jaunt is the players take on “Gunslinger” as Big Youth puts his unique spin on the Bo Diddley tale.  

The tracks which successfully manage to fuse the blues/reggae style such as Freddie McGregor singing the “Come On In My Kitchen” over the Sly and Robbie Beat while a distorted guitar cuts through the smoky haze or the short and super sweet take on Muddy Waters “Don’t Go No Further” by Andrew Tosh are worth seeking out. It is when things stay a bit one note that they aren’t as exciting, such as on the straight ahead “44 Blues” by Rose or the skittering “Baby Please Don’t Go” from Phylead Carley. Lesser efforts like “Temperature” from Big Youth has fine drum hits but stumbles through the chorus of the Little Walter jam, losing the originals appeal and the experimental album-closing “Sun is Shining” tries for too much.

A recording like the adventurous combo of “Wang Dang Doodle-Oh Well” shows the strengths and limits of the compilation as the first half delivers clunky duet between Shakespeare and Liguz, however when the song shifts to “Oh Well” Liguz takes the singing reigns with the outfit behind her lighting up and soaring. Toots Hibbard arrives to sing “Man of the World” and while missing the high notes to start, the track gains ground and sways with his raspy well-traveled voice.  

It sounds as if all involved are having fun on Red, Gold, Green and Blue and by simply having the ability to play and record with such titans of Jamaican music, Starkey and Liguz have roped in a debut release for their label they can be profoundly proud of.  

The post Zak Starkey Launches New Reggae Label Trojan Jamaica With Compilation LP ‘Red, Gold, Green & Blue’ (ALBUM REVIEW) appeared first on Glide Magazine.

This content was originally published here.