A video clip of a young American woman enabled by the first fully implantable hearing aid to hear her own voice clearly for the first time has become famous online.

Sarah Churman, aged 29, from Texas, was born profoundly deaf and has grown up using external auditory devices to provide partial hearing ability.

The surgical implantation of an Esteem device from Envoy Medical behind each ear resulted in her experiencing much clearer hearing.

Churman’s emotional reaction to her greatly improved hearing was filmed and uploaded to YouTube, where it became a massive hit despite user comments that showed ignorance about her condition.

The Esteem device is the first fully implantable hearing aid, with no microphone or speaker. Based on pacemaker technology, it is implanted under the skin behind the ear. Two leads extend into the middle ear from the device to sense the vibrations of the eardrum and auditory ossicles.

Churman commented that conventional hearing aids had never given her good discrimination of sounds or a sense of their distance: “With my hearing aids everything is jumbled, just white noise.”

Now, she added, voices were clear for the first time: “I could hear my two daughters’ words rather than having to read their lips.” In addition, she said, she was able to hear the sounds of rain, thunder and birdsong.

Each medical device and its implantation would cost nearly £20,000 in the UK, and is not available from the NHS.

Envoy Medical is based in Minnesota, USA.

A new CPAP (continuous positive airway pressure) device from Philips Respironics could enable people with obstructive sleep apnoea (OSA) to manage their own condition more effectively.

The new REMstar Pro (pictured) with AutoIQ is able to track the patient’s sleep breathing over several nights, establish or readjust to a set airway pressure, and check back periodically to adjust the pressure as needed – without clinician intervention.

The first phase of the AutoIQ mode, Auto-Trial, uses an algorithm for a total of 30 days to establish the patient’s treatment needs. At the end of the phase, the device analyses the data to identify and deliver the best airway pressure for the patient.

Following that, Auto-Check checks back every 30 hours to see how the patient is progressing and to automatically adjust the pressure if needed.

Auto-Trial days can be saved to reassess therapy at a later date if the patient’s physical condition or sleeping environment changes.

Throughout the process, AutoIQ keeps the care team informed of the patient’s sleep breathing performance and CPAP compliance.

“REMstar Pro with AutoIQ demonstrates our ongoing pledge to providers and their patients to be their ally in better sleep and breathing,” said John Frank, General Manager for Sleep and Respiratory Care, Philips Home Healthcare Solutions.

“By providing intelligent solutions and advancements in technology, we are shaping the future of sleep therapy.”

Philips Respironics is a unit of Royal Philips Electronics of the Netherlands, a market leader in cardiac care, acute care and home healthcare.

The FDA has approved Eli Lilly’s Cialis (tadalafil) to treat men with signs and symptoms of Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED).

The drug works by inhibiting the phosphodiesterase type 5 enzyme (PDE5), helping to produce vascular relaxation and increase blood flow to the penis. These enzymes are also found in the prostate and bladder, where problems can occur with BPH.

Claus Roehrborn, Chairman of the Department of Urology at The University of Texas Southwestern Medical Centre, said: “Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians.”

The approval totals three indications: both ED and signs and symptoms of BPH separately, as well as for men who have both conditions.

Dave Ricks, Lilly USA President, said: “These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health.”

“We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH,” commented Mr Ricks.

The FDA clearance was based on clinical research gathered from three placebo-controlled efficacy and safety studies involved 1,989 men.

BPH is a condition where the prostate enlarges, which can cause urinary problems. Approximately 50% of men between 40-70 years old suffer from erectile dysfunction. Several studies have shown that many men with ED also experience the symptoms of BPH.

The ABPI has welcomed a DH proposal to improve access to medicines for rare diseases – but cautioned against an increase in the use of unlicensed drugs.

The new initiative plans to commission expert assessments of off-label and unlicensed medication to inform doctors and patients before prescribing them – focusing in particular on hard-to-treat conditions such as rarer cancers and autoimmune diseases.

Stephen Whitehead, Chief Executive of the ABPI, said that the ABPI recognises the lack of licensed medicines for rare diseases, and that there can be important clinical reasons why people should be prescribed an unlicensed or off-label drug.

But he said that it is always “preferable for a medicine to be licensed for the purposes for which it is used and has been subject to the rigorous scrutiny of the regulatory authorities”.

“The regulatory and licensing system in the UK exists to protect the public, so the circumstances when an unlicensed or off-label medicine is prescribed should continue to be strictly limited to occasions where there is no suitable licensed alternative available and use is in the best interests of the patient concerned.

“We look forward to engaging with all government and healthcare stakeholders in the months to come to help shape the implementation of these proposals, and ultimately, improve patient access to new, innovative medicines”, he said.

On average, 1,000 specific requests for off-label drugs are made to NHS commissioners every year.

The Department of Health plans to give patients with rare illnesses better access to unlicensed or off-label drugs to treat their conditions.

The idea is for the DH to commission expert assessments of the use of off-label medication to inform doctors and patients to make “the best clinical decisions together”, says Health Secretary Andrew Lansley.

Andrew Wilson, Chief Executive of the Rarer Cancers Foundation, said: “This announcement is good news for patients with rare cancers and will help ensure all patients get access to good standards of care.”

Mr Lansley continued: “Wherever possible we should apply common sense solutions – especially to longstanding problems such as this – to ensure that patients can access the treatment they and their doctor think best for them.”

Treatment for hard-to-treat conditions, such as rarer cancers and autoimmune diseases, are sometimes only available for use in conditions where drug manufacturers are able to recruit enough patients to participate in clinical trials.

Mr Wilson commented: “When there are no licensed drugs available for a condition, it can be difficult to know how best to treat it. It is important that doctors are able to use their clinical judgement.”

At local level, NICE often does not have the evidence to make an informed decision to recommend the drug on the NHS.

Professor Anthony Redmond, Chair of the Arthritis and Musculoskeletal Alliance (ARMA), said: “NICE could play a valuable role in collating the evidence about what works in these conditions and this will be an important resource for clinicians in providing the best possible treatment to patients, and for patients in making an informed decision about the most appropriate option for them.”

Approximately 1,000 specific requests for off-label drugs are made to NHS commissioners every year.

A new HIV vaccine could turn the deadly condition into a ‘minor chronic infection’, scientists claim.

The initial testing of the vaccine, known as MVA-B, has found that 90% of volunteers developed an immune response against the virus, with 85% maintaining immunity for at least a year following the vaccination.

Professor Mariano Esteban, of the Spanish Superior Scientific Research Council (CSIC) in Madrid, said: “MVA-B vaccine has proven to be as powerful as any other vaccine currently being studied, or even more.”

The fundamental elements of the medication are based on a vaccine used to treat smallpox, with the addition of four HIV genes. The shot focused on the human immune system’s ability to ‘learn’ how to react over time against viruses and infections.

Jason Warriner, of the Terrence Higgins Trust, said: “This trial is a step in the right direction, but until we find a vaccine that controls the virus as well as anti-retroviral treatment does, we’re not there yet.”

The world’s first mobile-based system for diabetes management, developed by UK company Cellnovo, has received CE Mark approval for sale in the EU.

The innovative Cellnovo system (pictured) combines an insulin patch pump with a touch-screen mobile handset that wirelessly transmits real-time patient data to a web-based portal, enabling patients to keep track of their blood glucose control without needing to keep a diary.

The integration of medication delivery and monitoring technologies, completing the circle of type 1 diabetes control, is strengthened by Cellnovo’s recent agreement with US diabetes monitoring specialist LifeScan.

The successful OneTouch monitoring technology from LifeScan will be incorporated into the Cellnovo system, enabling that a very rapid fingerprick test can be used to generate readings.

The mobile handset is similar to the iPhone, while the patch pump is the smallest and most accurate on the market.

“Cellnovo has created the first insulin pump that combines form with function, essential qualities in a device that patients have to interact with 24/7,” said Dr. Pratik Choudhary, Clinical Lecturer in Diabetes at King’s College London.

Irl B. Hirsch, Professor of Medicine at the University of Washington, Seattle, USA, commented: “Cellnovo has combined advanced mobile and medical technology, which may create a paradigm shift in diabetes care.”

William McKeon, CEO of Cellnovo, described the CE Mark approval as “Cellnovo’s first step in a journey to bring this mobile diabetes management system to the world”.

Based in London, Cellnovo is a mobile healthcare company that specialises in diabetes management.

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”

A new technology that relieves the symptoms of chronic migraine by sending electrical pulses to the occipital nerves has received CE Mark approval.

The Genesis neurostimulation system from US company St. Jude Medical is the first such device to be approved for the treatment of intractable chronic migraine (ICM) in the EU.

The approval means that ICM sufferers in Europe will gain a proven alternative option for management of a painful and disabling condition.

ICM is defined as headache lasting at least 4 hours per day for at least 15 days per month, causing at least moderate disability and not responding to 3 or more preventative drugs.

The new system delivers peripheral nerve stimulation (PNS) of the occipital nerves in the back of the head, using small electrical leads placed under the skin.

The CE Mark approval was supported by the findings of a study of 157 chronic migraine sufferers carried out by St. Jude Medical. At 12 weeks, the active group (using Genesis) reported an average of seven fewer headache days a month, compared to one day fewer in the control group. The active group showed a 41% improvement in disability, compared to a 13% improvement in the control group.

Dr. Stephen D. Silberstein, Director of the Jefferson Headache Center and principal investigator in the clinical trial, said: “Through my participation in this study, I have observed the life-changing potential this therapy offers chronic migraine patients.”

According to Headache UK, over 5 million people in the UK suffer from chronic migraine, with women more than twice as likely to suffer from it as men. The cost of the condition, including lost working days, had been estimated at £2.25 billion per year in the UK.

St. Jude Medical’s neurostimulation systems for treatment of chronic pain have been used with more than 75,000 patients worldwide.

FDA approval has been issued to Intersect ENT’s implant offering controlled drug delivery for patients with chronic sinusitis.

The system prevents obstruction of the ethmoid sinus following surgery, reducing the need for additional surgical procedures and systemic steroids that can have serious side effects.

David W. Kennedy, Professor of Otorhinolaryngology at the University of Pennsylvania Health System in Philadelphia, USA, said that the combination of minimally invasive techniques and local drug delivery will be “the wave of the future in sinus treatment”.

Propel, a mometason furoate implant, uses advanced corticosteroid with anti-inflammatory properties. It is inserted following endoscopic sinus surgery to stop the condition returning.

The spring-like implant expands to prop open the sinus and gradually delivers the medicine directly to the sinus tissue.

Chronic sinusitis often requires a combination of surgical and medical treatments.

It is a common condition where patients’ sinuses become swollen and inflamed, leading to difficulty in breathing, facial pain or headache, and reduced sense of smell and taste.

Each year, 500,000 US patients undergo sinus surgery to treat the condition, but the majority of patients experience recurrent symptoms within a year of surgery.

The FDA approval is based on results from three prospective clinical trials involving 205 patients in the US.

Intersect ENT is a company based in Palo Alto, California, and focuses on developing treatment alternatives to improve quality of life for ear, nose and throat patients.