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Innovation 'Elevator Pitch':
Hy is a voice controlled, ear worn audio & biometric wearable for communication & wellness which can be worn all day and features an AI plugin architecture allowing tracking, analysis and interraction.
Overview of Innovation:
Hy is a pair of in-ear headphones, connecting to a host Bluetooth device to provide music, handsfree communication and notifications.
It also features biometric and inertial measurement features, allowing it to process information about the wearer and their environment.
In combination with its companion software, Hy will offer unprecedented features in a device of this type, binaural ambient recording, 3d positional audio, and an artificial assistant which acts intelligently - taking notes, retrieving search data, and much more - based on sensor data, time, location and, most powerfully - the context of the last few seconds of voice.
These features cannot be fully realised with any existing headphone design. Currently available headphone and earbud designs require the ear canal to be blocked in order to produce audible low frequency sound, as the acoustics of the ear canal result in high-pass filtering above 500Hz.
Because of this, current designs are by necessity bulky, intrusive and uncomfortable, with the added inconvenience of blocking out important sounds in the world around you, such that you must remove them to hear the world around you.
Hy is a Behind-The-Ear / Receiver-In-Canal package as typified by modern hearing aids, but with a radical, full-spectrum, in-ear driver which doesn't affect your natural hearing, removing the either/or nature of existing headphones.
As it’s worn all day, Hy is able to monitor the users health and wellbeing continuously. The companion AI will be able to detect elevated stress levels and recommend the appropriate steps. Hy is the first step in our vision of a happier, healthier smartphone free world in which we can communicate and share information in a more humane fashion.

Stage of Development:
Trial stage - Trial stage to prove that the idea actually works as intended
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Innovation 'Elevator Pitch':
Levo® Therapy System is an innovative sound based therapy designed for use during sleep. The system creates and delivers a personalised sound therapy that uses the brain’s natural plasticity to reduce symptoms and provide relief long term.
Overview of Innovation:
Tinnitus is a conscious awareness of a sound in the ears or head that is not due to an external noise. Every individual has their own very personal tinnitus tone. It can be a high or low frequency sound and its volume can vary over time. An estimated seven million people in the UK have experienced tinnitus at one time or another.
 
People living with tinnitus report that their condition limits their social life, their relationships and their opportunity to work (source: British Tinnitus Association patient website https://www.tinnitus.org.uk/).
 
Levo® Therapy System for Tinnitus is an FDA cleared and CE approved sound-based therapy which works with the brain’s natural plasticity to help the brain to get used to, or habituate, to the tinnitus sound within the hearing centre of the brain.
 
Levo® is specifically designed to be used during sleep when our brains are more prone to be responsive to sound therapies that strive to change brain activity patterns. The system enables patients to map their specific tinnitus sound, or ‘sound print’, to create a personalised sound therapy.
 
The personalised therapy sound is presented to the patient while they are asleep via an iPod device using a tailor-made proprietary ear phone system which is designed to be slept in (Levo® will switch itself off automatically during the night once the correct dosage has been applied). This stimulates the hearing centre of the brain with the goal to encourage habituation to the tinnitus sound and reduce the perceptual loudness / annoyance of the tinnitus signal. Improvements in tinnitus symptoms are tracked over time, which is motivating for the patient and provides useful guidance for the clinician.
 
The Tinnitus Clinic is suitable for patients with atonal or tonal tinnitus, or a mix of frequencies from less than 200Hz right through to beyond 10,000Kz. Levo® System therapy is a prescriptive approach which requires a single course of treatment over a period of 30-60 days.  Patients self-administer Levo® therapy during their night time sleep cycle and can carry on their normal daily life without disruption, including wearing hearing aids for hearing loss during the day if required.  Attendance at a clinic for follow up visits is usually one or two visits only.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Mental Health: recovery, crisis and prevention / Long term conditions: a whole system, person-centred approach / Digital health
Benefit to NHS:
Currently NHS management of patients with tinnitus can require clinic & GP attendance over a period of years alongside self-management techniques with treatment involving devices (hearing aids/sound generators) & counselling strategies aimed at reducing the negative emotional impact of the condition.
 
The Levo Therapy System provides a prescriptive pathway of treatment delivered by audiologists or hearing aid dispensers reducing the need for a multidisciplinary approach & freeing up time for healthcare professionals (GP's/audiologists/psychologists). Successful treatment with Levo Therapy would mean patients do not need to revisit GP/audiology/ENT services. It also has the additional effect of improving the patient’s emotional state without the need for psychodynamic intervention/pharmacotherapy delivering a cost saving advantage for the health service.
 
Using the NHS Reference cost schedule 2010-11 the conceptual (comparator) & the intervention (Levo Therapy model) have been costed.
 
An average patient receiving Levo Therapy will receive the device once in their lifetime at which point their tinnitus is managed & does not return, i.e. successfully habituates. The cost of the Levo Therapy pathway in the private sector is currently £4225 over a patient’s lifetime.
 
In comparison when looking at the average cost of the comparator arm of the technology which is the usual pathway for NHS tinnitus treatment, the weighted average lifetime cost per patient for these individuals is £8414.
 
Therefore for patients with a THI level 3 & above Levo Therapy generates savings of £4189 per patient when comparing NHS costs to private sector costs that include the service, fitting & follow up charges.
 
The weighted average cost is based on the multitude of resources required to manage tinnitus under the comparator technology over a patient’s lifetime such as:
  • Most patients require 2 digital hearing aids which need to be replaced every 5 years at a lifetime cost of about £1200 per patient, cost includes an assessment & fitting for each replacement
  • Digital hearing aids require continuous follow up appointments/repairs at a lifetime cost of about £4300 per patient
  • Most patients using hearing aids won't have their tinnitus managed & therefore will require a session of MTRT or CBT at a lifetime cost of about £580-£1200 respectively per patient per treatment
  • Once MTRT &/or CBT are successful patients will require counselling to sustain their tinnitus treatment at a lifetime cost of about £2533 p
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Benefit to WM population:
Hearing is central to our health & wellbeing. Hearing problems are a growing challenge across society & will become even bigger over the next decade due to the growing ageing population & increased exposure to workplace & social noise such as MP3 players.
 
It is estimated between 10-15% of adults will have tinnitus with 3% likely to require a clinical intervention for their tinnitus*. Reported prevalence of tinnitus varies from 12-36% & is more common in children with hearing loss compared to children with normal hearing. Like adults most children self-manage but a proportion require further support.*"
 
In some sections of the population tinnitus is statistically more significant for example 11% of veterans that were surveyed reported having problems hearing & 6 % reported tinnitus.**
 
Statistics show a higher incidence of tinnitus amongst UK Armed Forces than the general population^ & with the Royal Centre for Defence Medicine located at University Hospitals Birmingham NHS Foundation Trust & the HQ of the Surgeon General & the Joint Medical Command in Lichfield the regions Service community could benefit from access to the Levo Therapy System.
 
According to the Department of Health (2011) mental health problems are the largest single source of disability accounting for 23% of the total disease burden.*** The innovative ‘RAIDPlus integrated mental health urgent care test bed’ project highlights the region’s commitment to providing services for people with mental health illness.
 
Tinnitus is associated with a higher occurrence of depression than the general population (Holmes and Padgham 2009). Daugherty (2007) suggests at least 40-60% of patients with tinnitus also have a major depressive disorder, which often worsens their perception of the condition.***
 
For patients with tinnitus who have a depressive disorder The Levo Therapy System can improve emotional health & in turn the patient’s quality of life whilst reducing the burden on the health system.
 
* Davis, A, El Refaie, A (2000) “The epidemiology of tinnitus” in R Tyler (ed.) The Handbook of Tinnitus. Singular, pp 1 -23
** The Royal British Legion Household Survey 2014, November 2014.
https://www.actiononhearingloss.org.uk/supporting-you/policy-research-an...)
*** Hearing Loss, Tinnitus & Mental Health https://www.actiononhearingloss.org.uk/mentalhealth.aspx
*" https://www.england.nhs.uk/wp-content/uploads/2016/07/HLCF.pdf
^ https://www.cobseo.org.uk/british-tinnitus-association/
Current and planned activity: 
The Tinnitus Clinic is supporting the grants department of the Royal British Legion by raising awareness of access to the Hearing Fund for individuals with a military background whose tinnitus could benefit from treatment from Levo Therapy System.

The Tinnitus Clinic would welcome discussions with either military rehabilitation providers, CCG’s or Primary Health Care to test the use of Levo Therapy in their locations.

ROI would be with new patients within the first 6 months but could also be introduced as a disruption to current patients on treatment, allowing savings to be implemented even with patients further along the care pathway.
What is the intellectual property status of your innovation?:
Product Manufacturer Otoharmonics has two issued patents in the US and these patents are in the European National Phase Application No. 14818503.6.  Additionally, Otoharmonics has a patient pending for “Wireless Audio Device”.  “Levo” and “Otoharmonics are also Trademarked in the UK/EU.
Levo System is CE Mark Class IIa approved.
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
Regional Scalability:
The Levo Therapy is currently only available in the private sector. Ideally, we would like tos cale up by providing the treatment to NHS audiology departments, or primiary care practices with community audiologists. 
Measures:
Quality: CE and FDA approved QM systems ensure device quality. Patient experience is gathered through surveys and completion of Tinnitus Fuinctional Index questionnaires at the start and completion of treatment
Safety:  Safety is the role of the FDA and CE registration and we comply with manufacturers requirements for reporting adverse incidents , of which we have had none. 
Cost: The Levo Therapy costs £3995 inclusive of VAT in the private sector but this would not be cost price to an NHS commissioner
People: Quality of Life measures using the TFI recording. Suibjectgive measures during follow up appointments 
Adoption target:
The Levo Therapy is available privately and we would welcome the opportunity to provide this system to severe or catastophic patients within the NHS syetem, who are suitable for this treatment and have not responded to current NHS treatments. 
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Overview of Innovation:
More people die of SUDEP (Sudden Unexpected Death in Epilepsy) than in house fires every year.

Embrace is the world’s 1st system for seizure detection based on analysing multiple physiological data sensed at the wrist.


 
Should someone with Epilepsy experience an ‘unusual event’, such as a convulsive seizure, an alert will be sent via their smartphone to parents, friends or caregivers, summoning immediate help. Additionally, a caregiver can also wear a 'companion' Embrace. When the two Embraces are within range (e.g. in nearby rooms), the 'companion' Embrace worn by the caregivers will vibrate to alert them.



The Embrace watch has received awards for its design & innovative technology. The watch monitors Electrodermal Activity (EDA), also known as Galvanic Skin Response (GSR), which is autonomic data that is activated by regions deep in the brain involved in emotions such as fear, anxiety & excitement.
 
Embrace watch also functions as a sleep monitoring & activity tracking device.
 
What else do Embrace sensors monitor?
Embrace comes with an app called Mate. Mate combines events that are entered manually with events that are sensed by Embrace. Mate helps see how patterns of sleep, autonomic stress, skin temperature and physical activity may interact with seizure events. (NB: initial release of Mate app features rest and activity information, while features like autonomic stress monitoring, are still in development and will be added later). For example, if there are an increased number of absence seizures when stress levels have been high and sleep has been irregular, then these can be tracked to see if changing these patterns reduces the number of seizures.
 
Embrace and Alert app system for seizure detection is for investigational use only. The system is currently not clinically proven to detect seizures. Evidence of seizure characterization using the technology in Embrace has been gathered in a number of clinical trials since the initial discovery of skin conductance changes during a seizure was published in 2012. Empatica is currently conducting clinical trials to evaluate seizure detection of generalised tonic clonic seizures (GTCS) using the Embrace watchEmpatica Alert app.
 
The automatic physiological data logging provided by the Embrace system is valuable when someone experiences a seizure as they may not remember what has happened themselves. A diagnosis is often based on finding out what happened to the individual before, during and after a seizure.
 
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Innovation 'Elevator Pitch':
A holistic tinnitus treatment app designed by audiology and ENT specialists that will provide patients with tinnitus education, self-help therapeutic exercises, psychoacoustically tailored sound therapy and efficacy outcome measurements.
Overview of Innovation:
Tinnitus is the involuntary perception of sound, that is localised to within the ears/head, and has been reported to affect 10-15% of the global adult population. 
 
The vast majority of cases are induced by hearing loss. Hearing loss casues changes in neuronal activity patterns within the central auditory system and occur as a result of organic mammalian hearing loss.   However, sudden onset hearing loss cuased by loud noise exposure or some damage to the auditory cortex can also result in tinnitus.

In a significant number of individuals (0.5-1.5%) this can have a severe impact on quality of life due to resultant secondary symptoms such as anxiety; external sound sensitivity; insomnia.

Currently tinnitus is treated by helping the patient to habituate to the noise; so that the perception becomes filtered from conscious awareness much in the same way as the majority of body noises are (i.e. respiration etc.).  Techniques like educational counselling, relaxation, meditation, cognitive behavioural therapy (CBT) and sound therapy are all employed to provide ad hoc control over patient emotional reactivity and perceptual awareness in order to act as a catalyst to the habituation process. 

These complex therapeutic techniques require significant clinical time, resource and expertise in order to be efficacious.  
 
The Tinnitus Clinic Ltd. proposes to design a treatment app to prototype stage for tinnitus. This app will combine a number of evidence based interventions that can be delivered to the patient via one platform in a remote fashion. 
 
There will be both pro bono and chargeable features. 

Users will be able to grade their tinnitus severity via validated questionnaires and access education tools relating to tinnitus aetiology, the progression of the condition and self help techniques.  

Patients will also be able to determine the pitch of their tinnitus and basic hearing acuity in order to provide guidance with respect to basic sound therapy options. 
 
Chargeable services such as spoken word relaxation/mindfullness meditation exercises, CBT techniques and non-bespoke sound therapy options could be available for a monthly fee.   

A more sophisticated array of bespoke sound therapy techniques will also be available but would require the patients to attend a tinnitus clinic in order to undergo testing and calibration of the treatment signal.  Fit for purpose ear/head phones would be provided to enable signal delivery during the day or whilst the patient sleeps. 
 
 
Stage of Development:
Ideas stage - Early concept and ideas stage
WMAHSN priorities and themes addressed: 
Mental Health: recovery, crisis and prevention / Long term conditions: a whole system, person-centred approach / Wellness and prevention of illness / Education, training and future workforce / Digital health / Innovation and adoption / Person centred care
Benefit to NHS:
Use of this innovation would reduce appointments taken with GPs and unnecessary visits to audiologiy departments. As both an education and treatment tool the medtech app could treat the majority of people who suffer from mild or moderate tinnitus and need basic support and reassurance. 
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Benefit to WM population:
10% of adults in the west Midlans have tinnitus, and of those around 90% will have mild to moderate tinnitus which does not need treating formally. 
Current and planned activity: 
We have no current activity with NHS for treating patients. However, we do provide training and education on tinnitus to GPs. 
What is the intellectual property status of your innovation?:
Not yet patented .
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
2 years
Ease of scalability: 
Simple
Regional Scalability:
As this is a digital technology, scaling up geographically is a straightforward process.
Measures:
Quality measures: functionality; ease of use;  all information, diagnosis and treatment functions to be evidence based; Tinnitus Functionality Index scores reduced over 3 months of use of app; 
Safety Measures: No adverse events reported at prototype stage or in the ongoing development; 
Cost: Within budget for the prototype with full budget developed for stage 2 (development, marketability and implementation)
People: Quality of life improves using TFI as measure (see quality)
Adoption target:
The protoype would be tested in  a West Midlands population . We would seek to establish an NHS partner to test this at Primary Care level in the later stages of development . 
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