Oct 2017 IEEE Spectrum

For the patients with severe vertigo who come to Charles Della Santina’s lab, life is full of constraints. The constant dizziness interferes with their social and working lives mainly because of the limits it places on their mobility—they often can’t walk without a cane and can’t drive cars.  

“These people don’t have much hope,” says Della Santina, director of the Vestibular NeuroEngineering Laboratory at the Johns Hopkins School of Medicine. “They come to us after being told by many doctors, you’ll have to learn to live with it, because there’s nothing we can do to help you.”  Della Santina hopes to change that. His lab is currently conducting the first human trials of an inner ear implant that restores patients’ balance by constantly stimulating the vestibular nerves leading to their brains. The team is testing the implants’ safety and efficacy with five patients initially, and hopes to eventually commercialise the device through a spinoff company, Labyrinth Devices.

VertigoOnly a few vestibular implants have been tried before, and one of those trials had unfortunate results. A study at the University of Washington in Seattle aimed at treating vertigo caused by Ménière’s disease ended early when the first four patients lost their hearing in the ear in which the device was implanted.
But the Johns Hopkins trial has already showed good preliminary results, with no adverse effects. The initial three patients to receive the implant have all experienced improvement, says Peter Boutros, a PhD student in Della Santina’s lab. “When our first subject came to the clinic, he used a walking stick to get around, and if it was dark he had to hold onto his wife or a railing,” Boutros says. At the end of the eight-week study, “he sent us a video of him running on a treadmill.” 

Internal EarThe implant is designed to help people with damage to the delicate anatomy that makes up the vestibular system. The inner ear has three tiny structures called semicircular canals that track the head’s rotation along three axes (imagine nodding, shaking your head, and tipping your left or right eyebrow up). Fluid in these canals pushes on sensory hair cells that change the mechanical signal to an electrical one in order to send information up the vestibular nerve.  The initial three subjects in the study had damage to their sensory hair cells due to certain antibiotics that are known to be toxic to the hair cells but are sometimes quite critical to patient care. “Sometimes it’s a life or death situation,” Boutros explains. Patients may be given the antibiotic and, since they’re lying still in a hospital bed, may not notice the onset of dizziness until it’s too late and permanent damage has been done. 

To make the device, the team modified an existing cochlear implant used for hearing loss. “There’s roughly a $100-million difference between making an implanted stimulator from scratch and adapting an existing stimulator,” says Santina, because commercial devices have already passed regulatory reviews for safety.

The device includes an external component worn on the head that contains both a gyroscope to track the user’s head rotations in three dimensions and a processor, which sends the rotational data to the internal implant to electrically stimulate the vestibular nerve. The implant uses nine electrodes to convey the information that would normally come from the three semicircular canals. 

The patients in this initial trial have the implant in only one ear as a safety precaution, but in a commercial device, users might have implants in both ears for maximum effect. The electrodes continuously stimulate the nerves using an encoding scheme that the researchers customise for each individual patient. Over the course of the eight-week trial, the patients have reported that their vertigo has gradually decreased, which Santina says is a sign that their brains are learning to trust the information coming from the vestibular nerves. “The brain is readjusting to the new normal,” he says.
While the implant could help many people with damage to their inner ears, it won’t help people whose vertigo is caused by problems “downstream” of the vestibular nerve in the brain.
Della Santina says there’s a “special graveyard for people who make overly optimistic estimates about when their device will be approved” by the FDA. But he notes that the vestibular implant should qualify for a humanitarian device exemption, a fast-track FDA approval process that encourages the development of technology for rare diseases. Della Santina is eager to get the device to market so it can help the people who walk into his clinic with little hope: “Our patients who are 60 years old are really eager to get something now, so they can play catch with their grandkids,” he says.

While the implant could help many people with damage to their inner ears, it won’t help people whose vertigo is caused by problems “downstream” of the vestibular nerve in the brain.
Della Santina says there’s a “special graveyard for people who make overly optimistic estimates about when their device will be approved” by the FDA. But he notes that the vestibular implant should qualify for a humanitarian device exemption, a fast-track FDA approval process that encourages the development of technology for rare diseases. Della Santina is eager to get the device to market so it can help the people who walk into his clinic with little hope: “Our patients who are 60 years old are really eager to get something now, so they can play catch with their grandkids,” he says.

 

Oct 2017 Manchester Evening News and itv.com

A mother who has been practically deaf since her twenties will finally able to hear her daughter’s voice properly - thanks to an iPhone gadget trialled in Manchester. Hearing loss and tinnitus has made Di Matthews’ life a ‘nightmare’ at times. But now the 41-year-old can control her hearing through Apple devices. An implant embedded in her ear is connected to an innovation called the Nucleus 7 Sound Processor. With time, the technology should not only enable her to pick up a greater range of sounds than she would with hearing aids, but also allow her to transmit phone calls and music to her brain through an iPhone or iPad. The mum-of-one is one of the first people in the UK to test out the technology, which was trialled at Manchester Royal Infirmary.

Di MatthewsDi, who lives in Rotherham, South Yorkshire, has suffered deafness for nearly twenty years. “I remember going to the GP and him telling me I had a head cold”, she said. “It wasn’t until I went for an MRI that I found out I had nerve ending damage in my ears, and my hearing has gone gradually year on year since”, she said. “I did have bilateral hearing aids, but day to day I still found it hard, and was restricted from doing so many things.
Work became increasingly difficult - my employer has done as much as possible for me - but it got to the point where I was wondering if I could keep doing my job without an implant. I’d go to my daughter’s school assemblies, I couldn’t hear anything that was being said, but she could see me so she was happy. I can’t talk to her about school on the drive home because I can’t see her to lip read and the sound of the engine means I can’t hear. I struggle to have a full conversation with my husband, it’s little things like that I’ve missed out on. I shy away from phone calls and rely on emails, I can’t go to the pictures or theatre unless it’s subtitled or special viewing.”
It will be several weeks before Di notices a major difference after switch-on. Immediately after the switch on at the MRI, Di was able to hear some speech, but mainly a ‘morse code’ style sound which will become clearer in time as she adjusts to the pitches and tones. She is also looking forward to finally being able to enjoy the music of her husband, Peter, a percussionist for Grimethorpe Colliery Band, which featured in the 1996 comedy Brassed Off.

 

Oct 2017 Newcastle Herald

Bella ChislettHello dolly: Bella Chislett with her preferred doll Isabelle, who wears cochlear implants like her owner and was made by Bella's mum Jade, who runs niche business Just Like You Dolls. Picture: Marina Neil

BORN with congenital hearing loss, Bella Chislett was eight months old when she received her first cochlear implant, and had barely marked her first birthday when she got her second. “It made a big difference, the small things like being able to hear a bird singing in the trees and me speaking to her,” says mum Jade of her daughter, now five. “We did a lot of intensive therapy and now her speech is average with her hearing peers.” Also helping Bella along her path to greater resilience is her trusty doll Isabelle. Isabelle has cochlear implants like Bella and was the prototype that inspired Mrs Chislett’s expanding niche business, Just Like You Dolls.
“Bella has always loved her dolls and been a little mother hen and when she was three I was looking at her playing and thought ‘I’d like to give you a doll that’s just like you’, because she used to put her own cochlear implants on the doll,” says Mrs Chislett. So just before Christmas last year, she took a koala toy with cochlear implants gifted to Bella after her cochlear implant operation and took it apart. She removed the plastic implants, drilled holes into them, bought a new doll and used magnets to attach the implants. “When Bella opened the present on Christmas Day she just squealed  the first thing she said was ‘it has special ears just like me’.”
Mrs Chislett soon found herself making a doll with hearing aids for a girl in one of Bella’s therapy classes who had grown attached to a doll with aids she’d made for her second daughter, Evee.
 “When I gave it to this girl, just the look of pure joy on her face, and her mum later telling me how much she adored it, I knew I had to do something more,” she says. Spurred on by her hubby Josh, Mrs Chislett joined forces with his dad Michael to found Just For You Dolls. They source dolls from overseas then use a 3D printing machine to manufacture the medical device attachments, ranging from cochlear implants and hearing aids to glasses and a stoma and bag. Customers can choose from one of 10 dolls then add one device or more to suit their child. Prices range from $25 to $150.  Mrs Chislett sews on the devices to each doll, and uses magnets to attach others. 
 

Word of mouth is spreading. One of Bella’s support teachers has bought 15 dolls she says have made a “huge difference” in her classes.  Mrs Chislett’s business has had a positive impact in more ways than one for Bella. “She’s far more aware of other hearing loss types and disabilities, and she helps me mail out the dolls,” she says. “People are hesitant to ask Bella about her cochlears but now she takes her doll out and she gets comments on how her doll has beautiful hearing aids and it opens a conversation and people are more comfortable,” she says.

 

Nov 2017 The Chester Standard

A hero nurse has won an award following a heartfelt nomination by a former patient from Wirral. Pip Page-Davies, who works at the Robert Jones and Agnes Hunt Orthopaedic Hospital (RJAH) in Oswestry, received the NHS trust’s Patient Choice Award at a glitzy ceremony. She had been nominated by Bethany Eason, 20, who endured an excruciating journey after being diagnosed with an aggressive tumour in her knee. Bethany, from Bebington, said Pip had been a rock, sharing “blood, sweat and tears” with her since the shock diagnosis in March. She told the Standard: “I’m absolutely thrilled that Pip received the award. I was privileged to have been in her care and I could not have got through my tumour diagnosis and tough journey without Pip.
“If every hospital had a Pip and an Oswald Ward imagine how much better the NHS would be!  “Nurses like Pip are worth more than their weight in gold.”

Pip Page-DaviesBethany had twice fractured her leg before doctors discovered the rare tumour and then went on to have a knee and thigh bone replacement. Throughout her treatment and recovery, Pip was always at her side to offer help and comfort, often staying well beyond the end of her shift.

Bethany, who is profoundly deaf and wears a cochlear implant to help her hear, also needed help understanding some medical explanations when they were not delivered face to face.

She said nurses and the NHS rarely receive the recognition they deserve and she had seen first-hand the outstanding work they do. Pip said she felt “shaky” when she first heard about the nomination as it is such a “huge compliment” to receive such glowing feedback from a patient.

“When I learnt I’d been shortlisted and the nomination had come from Bethany and was able to read her words I was tearful,” she said. “The fact that I had been able to make a situation just a little bit better made me feel so very proud to be a nurse.” Describing her approach to nursing, Pip said: “I always try and provide individualised care and understanding what matters to the individual. “Listening to patients is so important and allows them to feel respected. Respect usually promotes trust, something else that enhances the patients treatment and I strive to get this right for every patient. So, not waking her up but leaving a note when my shift had finished or plaiting her hair when she couldn't get in the shower, always facing Bethany and regularly repeating what others had said so Bethany understood mattered to me so meant a lot to her.

Bethany demonstrated a strength of character and determination and this was to be admired.”
She added: “To receive the Patient Choice Award means the world to me. It’s a moment I’ll treasure. “I would like to thank Bethany for taking the time to nominate me and everyone who voted for me.”