Final Report Summary - PIEZOSELEX (Piezo Pair Materials for the Selective Exclusion of Workplace Noise)
Executive Summary:
PiezoSelEx is a two-year project funded by the European Commission’s Framework 7 Programme, within the ‘Research for SMEs’ scheme. The PiezoSelEx consortium is made up of a well balanced team of organisations who have been selected on the basis of their expertise in fields that are complimentary to the projects development. The specialist knowledge of each consortium member covers a number of subject areas including piezo material manufacture, piezo material science and research, medical device development and manufacture and the hearing loss industry.
There are 700,000 SMEs in the key industry sectors of manufacturing and transport across Europe currently dealing with reduced productivity due to Noise Induced hearing Loss (NIHL). It is estimated that 572,000 people are diagnosed as suffering from occupational NIHL resulting in an estimated loss per annum of €345M to these key business areas.
Although EU legislation requires employers to provide suitable ear protection, the view of many employees as that due to a number of issues they do not wear them. The two key issues cited are:
• The impact on general hearing capability, i.e. conversation and warning signals, for example fire alarms.
• Incompatibility with other items of safety equipment, i.e. glasses, helmets, breathing apparatus.
The problem of Noise Induced Hearing Loss (NIHL) in the work place is a problem for a vast number of SMEs and European workers in general, particularly those in the manufacturing and transport sectors. NIHL results in reduced productivity from lost work days, insurance claims and potential early retirement due to disability. Current EU legislation requires employers to provide suitable ear protection for workers exposed to high levels of noise. However, worker compliance in hearing conservation programs often is low. The attitude of many workers is that the use of hearing protection impairs hearing capability. Therefore a suitable alternative to existing ear protection is needed – one allowing specific ranges of sound frequencies (i.e. those within the range of speech and alarms) to be heard whilst significantly reducing other potentiallyharmful noise frequencies.
In summary the PiezoSelEx device will:
• help promote productivity due to easier communication
• reduce the risk of NIHL by reducing noise levels
• contribute to a more comfortable work environment due to perceived lower levels of noise
• reduce employee absenteeism due to increased wearer comfort and a reduction in NIHL
• contribute to a safer working environment as warning signals such as fire alarms and local machine alarms will be easier to hear.
There are also a number of wider benefits for Europe. In addition to working environments currently protected by legislation, our device may provide a driver to enforce new legislations, particularly in the entertainment industry.
The final outcome of the project was to use a bespoke digital signalling processor with multiple channels that could be programmed to the users’ environment. The use of extra channels means that there is the potential of a common frequency modulation (FM) receiver that would broadcast announcements or alarms.
This technology can also be applied to the Hard of hearing market as mentioned, where the system can be used to amplify frequencies that are bespoke to the users hearing loss and the potential for direct interface or wireless interface into audio sources such as TV, Radio and Bluetooth mobile phones. We believe that PiezoSelEx will be the first independently programmable in the ear system to be able to provide either active noise reduction/band pass or both whilst having independent channels for receiving FM communication.
Project Context and Objectives:
The issue of Noise Induced Hearing Loss (NIHL) in the workplace is a problem for a vast number of SMEs and European workers in general, particularly those in the manufacturing and transport sectors. NIHL results in reduced productivity from lost work days, insurance claims and potential early retirement due to disability. Current European Union (EU) legislation requires employers to provide suitable ear protection for workers exposed to high levels of noise. However, worker compliance in hearing conservation programs is often low. The attitude of many workers is that the use of hearing protection impairs hearing capability. Therefore a suitable alternative to existing ear protection is needed – one allowing specific ranges of sound frequencies (i.e. those within the range of speech and alarms) to be heard whilst significantly reducing other potentially harmful noise frequencies
There are 700,000 SMEs in the key industry sectors of manufacturing and transport across Europe currently dealing with reduced productivity due to Noise Induced hearing Loss (NIHL). It is estimated that 572,000 people are diagnosed as suffering from occupational NIHL resulting in an estimated loss per annum of €345M to these key business areas.
Although EU legislation requires employers to provide suitable ear protection, the view of many employees as that due to a number of issues they do not wear them. The two key issues cited are:
• The impact on general hearing capability, i.e. conversation and warning signals, for example fire alarms.
• Incompatibility with other items of safety equipment, i.e. glasses, helmets, breathing apparatus.
In summary the PiezoSelEx device will:
• help promote productivity due to easier communication
• reduce the risk of NIHL by reducing noise levels
• contribute to a more comfortable work environment due to perceived lower levels of noise
• reduce employee absenteeism due to increased wearer comfort and a reduction in NIHL
• contribute to a safer working environment as warning signals such as fire alarms and local machine alarms will be easier to hear.
There are also a number of wider benefits for Europe. In addition to working environments currently protected by legislation, our device may provide a driver to enforce new legislations, particularly in the entertainment industry.
The link between exposure to noise and damage to hearing is well known and internationally accepted. It is clear that noise at work poses a serious but often underestimated threat to millions of European workers. An estimated one third of Europe’s workers (more than 60 million people) are exposed to high levels of noise for more than a quarter of their working time. According to European survey results 7% of European workers consider that work affects their health in terms of hearing disorders. Hearing impaired individuals may suffer from social, psychological and physical problems; they are twice as likely to be unemployed and average earnings are 50-70% of those achieved by non sufferers.
The EU considers hearing impairment as one of the biggest health and social issues. Estimated annual expenditure as a result of hearing loss is €106 billion (€260 per EU citizen) and societal costs are estimated at €92 billion/year8. Current ear defenders attempt to reduce the financial impact by protecting workers from noise, but clearly don’t prevent all cases.
According to the European Agency for Safety and Health at Work, about 7% of ALL workers in the EU-15 members states in 2001 were affected by occupational NIHL. Thus, with 65.9 million people in the EU-27 employed in 2008 , 4.4 million workers across the EU are affected by NIHL. Over-exposure to noise at work results in increased levels of absenteeism and early retirement, resulting in decreased company productivity and thus competitiveness.
The PiezoSelEx device is able to contain the required functionality, yet be small enough to be contained within an in-ear device ensuring compatibility with other essential items of safety equipment such as helmets and goggles and be comfortable for wearers to use for extended periods of time.
PiezoSelEx device will therefore meet an important need for the European employees where exposure to noise, particularly in the important SME dominated industries of manufacturing and transport, causes problems for a significant proportion of the workforce. Ear defenders currently on the market do not fully satisfy the workers needs particularly with regard to effective noise cancellation whilst still enabling them to communicate or hear alarms and are not very comfortable to wear. Training on how to wear them correctly is frequently inadequate and workers are often reluctant to wear them. The PiezoSelEx will satisfy these needs improving both the effectiveness and the ability to communicate with thoughtful design providing the comfort factors workers need to encourage regular use. The elimination of large batteries and circuit boards will enable our device to be made small enough and light enough to fit in the ear. The device will be marketed at an affordable price with a negligible increase over a standard basic ear defender.
The first 14 months was devoted to both the modelling and selection of piezo materials and the ergonomic design of the earplugs. Once the design stage was sufficiently underway, a simple prototype was built and tested. Miniaturisation of the prototype was then incorporated into the design. Validation studies and laboratory testing were then undertaken in preparation for user trials. The final 6 months was dedicated to the user trials to demonstrate the feasibility and economics of the prototype technology in situ.
The first stage of the project and WP1 therefore was to carry out the characterization of the various Piezo materials available. This enabled us to determine the optimum type for collecting airborne sound and using the electrical energy generated to power the second, sound cancelling, elements.
The proof of concept was demonstrated in WP2 in which the effectiveness of noise generation against predictions was assessed and a working model built to demonstrate noise cancelling characteristics over a range of frequencies in a semi miniaturised model.
A detailed analysis of the in-ear defender market in Europe was undertaken looking at a wide range of parameters and expectations for PiezoSelEx was established through questionnaires and focus group meetings as part of WP3. The information obtained was combined to specify a design which took into account bio and environmental compatibility and also to ensure compatibility and non interference with the piezo elements. The resulting CAD drawing was used to produce prototypes in each of the specified sizes to assess comfort and fit for users in the 5th-95th percentile of the population.
Final prototype build, validation and user trials were undertaken in WP4 and WP5. In WP5 we also coordinated user trials and established feedback with a number of volunteers
The final prototype using two piezoelectric elements was found to have an attenuation of below the required level for an effective hearing protection device and the output from the piezo emitter was masked by the external workplace noise.(See Task 5.2 below)
In order to correct these failings, several changes were made to the final optimised prototype including modification of the ear bud and a change in physical components inside the ear bud itself and amplifier modules.
With the introduction of the DSP Chipset and the attenuation of the soft bud has meant that we can exploit the versatility of the chipset, the channels it offers and the programmability of the chip for both the targeted market of Ear Protection as well as a potential new market for Hard of Hearing. For the latter case, 55 million people in the EU have a hearing loss, 1 in 6 wear hearing aids, Over 45 million struggle either ignoring their loss as there is stigma attached to the subject, they choose to ignore it or cannot afford instruments. PiezoSelEx can benefit not only existing hearing aid users but also the 45 million that ignore their loss. The system would be ideally priced at €300, placing it at the lower end of the Existing FM Market. Furthermore PiezoSelEx is the first programmable directional assistive listening device capable of integrating with all Bluetooth and FM transmitters within frequency and first Assistive listening device that can be programmed by the user to their specific hearing loss.
PiezoSelEx Transmitter can be used both with the new emerging market of Bluetooth Hearing Instruments and with an induction loop or noise cancelling Headphones as a TV Listener.
Manufacturing software and maintenance target<€100 per unit, with a distributor price €150 and .05% (5 in every thousand) target penetration in three years of hearing aid market alone would result in €6,875,000 total turnover. With EPITDA of €2,291,666, a penetration of the non-hearing aid user market target of .05% (5 in every ten thousand) = €3,375,000 if sold indirect through distribution or €6,750,000 if sold via ecommerce. With EBITDA €1,145,83 indirect or €4,455,000 direct ecommerce and total units sold in three years 68,750
Project Results:
PiezoSelEx was split into four phases, each containing defined work packages (WPs), with associated tasks and deliverables.
• Phase 1 (WP 1) – Months 0 - 6:
Review of available airborne sound and current ear defender state of the art. Using advanced modelling to carry out a characterisation of the various piezo materials available to determine the most suitable material. Use this modelling to generate a theoretical design for the PiezoSelEx solution.
• Phase 2 (WP 2 & 3) – Months 7 - 14:
This was mainly development phase. Here the theoretical design from WP1 was initially progressed into a physical proof of concept before miniaturising to a final ear defender prototype solution.
In parallel, ergonomic investigation and design were completed to provide the method of encasing the physical ear defender and providing a suitable fit for the 5th – 95th percentile of the population.
• Phase 3 (WP 4 & 5) – Months 15 - 24:
This phase was the manufacturing of the final prototype design generated in WPs 3 & 4 and evaluation against the requirements for the project. The evaluation also included user trials to provide feedback from real people in real environments.
• Phase 4 (WP 6 & 7) – Months 0 - 24:
This phase ran for the duration of the project. It covered the exploitation and dissemination strategy for PiezoSelEx, including managing any appropriate IPR and patents.
WP1 was related to Modelling and Selection of Piezo Materials – by undertaking characterization of the various Piezo materials available. This enabled us to determine the optimum type for collecting airborne sound and using the electrical energy generated to power the second, sound cancelling, elements. Task 1.1 Piezo material review, purpose of which was to review the energy budget for the device, how much energy could be harvested, and what could be achieved with the available energy, using the most appropriate piezoelectric materials for an in ear defender application.
Initially the requirements of the device were refined in order to clarify the scope of the design. At this review it was decided that some of the most important factors were that the device should be in-ear, i.e. not impede wearing other equipment such as glasses or helmets, battery-less and with no wiring etc. protruding from the ear, and low cost. A patent review revealed that there were only a few devices that used piezoelectric materials in hearing related applications and no devices used piezoelectric as both an energy harvester/microphone and emitter/loudspeaker. The requirement of Task 1.2 Device Design & proof of Concept Modelling, were to develop designs for the device for refinement in task 1.3.
The initial scope was for multiple pairs of receiving and emitting piezoelectric elements, however given the space requirements it was felt that at this stage the focus should be on using a single pair to prove the concept. The device design needed to accommodate conflicting requirements, a small volume in order to fit inside the ear, and large area to harvest acoustic energy and maintain an audio frequency bandwidth.
The energy budget had revealed that there was little scope for active solutions, and energy harvesting with storage would be wasteful in energy and space terms. For this reason the only viable solution was to use resonance to maximise the response of the system, and this was the approach taken thorough the rest of the design stages. Models, semi-analytical and finite element, were developed to look at the effects of connecting two piezoelectric materials back to back in an acoustic application. Initial results using solid piezo materials showed that PZT ceramic materials had a high sensitivity but poor coupling to air, whereas polymeric PVDF had better coupling to air but much reduced sensitivity. Additionally, a review of audio frequency applications using piezoelectric materials showed the most appropriate device was to use a flexural mode by backing a disc of piezoelectric with passive material. Other ideas developed to increase coupling to air of the receiving piezoelectric included adding flared horns or a Helmholtz resonator.
Task 1.3 relating to Final Piezo material selection was to consolidate the research in tasks 1 and 2 in order to provide a blueprint for the building and testing of a prototype device in Work Package 2. The finite element model was developed to include a Helmholtz resonator at the input stage, two electrically connected piezoelectric discs, each with a backing material, and the output piezoelectric acoustically coupled to a model of the ear canal. This model was optimised to give the maximum acoustic output at the ear canal, for a 1Pa incident acoustic pressure. The optimisation included a range of materials, their typical dimensions and also limited dimensions to a volume that fitted within the original device specifications. The optimisations showed that using a PMN-PT receiver, and a PVDF emitter, a signal at 2kHz could pass through the device with zero loss, and using a PZT receiver only a 15dB loss is seen
Significant Achievements in Work Package 1:
• The energy budget had revealed that there was little scope for active solutions, and energy harvesting with storage would be wasteful in energy and space terms. For this reason the only viable solution is to use resonance to maximise the response of the system
• The energy budget for the device based on purely piezo materials has been identified
• Blueprint for the building and testing of a prototype device in work package 2 provided and consist of using a PMN-PT receiver, and a PVDF emitter, a signal at 2kHz could pass through the device with zero loss, and using a PZT receiver only a 15dB loss is seen.
WP2 was concerned with simple prototype build and miniaturisation , in which we demonstrated the proof of concept by measuring the effectiveness of noise generation against predictions. The study was extended to investigate the frequency selective components necessary to ensure speech and alarms can be heard.
The research undertaken in WP1 identified that the current proposal to use multiple sets of piezo pairs to work in anti-phase and cancel work place noise is not a viable solution. The main reason for this is that it has been shown through modelling, that using multiple pairs would not allow the harvesting of sufficient energy to power the system.
The proposed change was to still use piezo pairs, so keeping to the concept of the system and the project, but to use a single pair which, when used in conjunction with a Helm-Holtz resonator on the receiver, will be able to harvest sufficient energy. As only a single pair is to be used this needs to be selected to work at the voice frequency band. The remaining noise frequencies was eliminated by the use of a passive block.
Task 2.1 Prototype build and performance measurement using test system. The testing set-up was based around a planar wave tube manufactured by Bruel & Kjaer. This allowed the material to be tested to be fitted at one end of the tube and the actuation or measurement device at the other
Task 2.2 Frequency selection optimisation in which we identified the methodology for selecting most appropriate frequencies for the given work environment in which the receiver/emitter system will be used. Based on the concept and requirements defined for the system in WP1, the solution proposed was based on all previous requirements that have been put forth in previous tasks and WPs; Task 2.3 Miniaturisation issues and prototype, in which we miniaturized the receiver/emitter system used in the proof-of-concept (laboratory level) using commercial components following the design guidelines outlined in WP1 and taking into consideration the limitations imposed by time and the commercially available components
Significant Achievements in Work Package 2:
- The ability to tune the working frequency of the receiver in three different ways.
- The ability to adjust the emission frequency of the emitter:
o Designing an emitter with the minimum voltage input possible, so as to increase the number of potential working frequencies of the system.
o The PVDF emission frequencies can be tuned by changing the radius of curvature of the PVDF membrane.
- The proof of concept of the PiezoSeLex concept and its miniaturisation has been carried out successfully.
- A functional characterisation of this device was proposed for WP3 that addresses those aspects that have not been possible to do in WP2 such as the material used to encapsulate the ensemble receiver/passive material/emitter, which should improve the sound attenuation of the environment, and those aspects related to the ergonomic design of the prototype.
In WP3 the focus groups and questionnaires analysis provided the main design parameters that should be included in the device. A data base with ear dimensions allowed us to select the three sizes of the final prototype in order to provide adequate fitting of 90% of the total population. Within this task we also developed a methodology for enabling ear dimensions to be taken and a pre-production validation to assess overall ergonomics of the device. Task 3.1: Analysis of focus groups and questionnaire was aimed to gather information from end-users about current situation, expectancies and requirements for the PiezoSelEx device from current hearing protection users across Europe. Task 3.2: Ear characterisation’s main objective was determining variations in ear dimensions across age, gender and regions in order to ensure a design for the PiezoSelEx device that fits the 5th - 95th percentile of the population. Task 3.3 was related to material assessment in which the focus was to establish and select the best materials for the PiezoSelEx device consisting of the proposed outer shell (fix component that contains the Piezo elements) and a soft bud (removable component).
In the design process, an important requirement, pointed by users and experts, has been the easy replacement of soft buds. For this reason, one of the main points in Task 3.4 was focused on the design of the mechanism to ensure easy replacement of soft buds as well as be as small as possible to maintain the user´s comfort. In this task, the soft bud concept in three sizes were designed so that when placed over the device they merge to create the overall sizing requirements to fit users in the 5th-95th percentile. The selection of soft bud size was also determined from the ear characterization developed in Task 3.2. In Task 3.5 we created a fully CAD drawing of the fully conceptual design of the soft bud (foam and mushroom shape) as well as the outer shell of the PiezoSelEx device
Significant Achievements in Work Package 3:
• The ear protector that workers usually wear while working established.
• The hearing protector problems including the advantages, comfort and effectiveness perceived by the respondents of the ear protector they currently use identified.
• Ear protector selecting criteria when choosing ear protection equipment established.
• List of requirements that should be included in the new system PiezoSelEx device to make it safe and ergonomic for hearing protection’s users established
• Acquisition of a representative full range of Europeans exposed to occupational noise, where factors in choosing individuals include age, gender and geographical location.
• A reliable and safe method of ear shape acquisition and the quantitative shape characterization defined.
• Method to align the individual shapes that optimizes the internal volume where the filters will be located established.
• Internal volume to set up the dimensions of the available space inside the outer ear modelled.
• Established three different sizes (small, medium and large) for the device based on the various ears dimensions obtained from the study including the best three sizes of the device that assure an adequate fitting of 90% of the total population.
• Biocompatibility in the selection of the materials, guarantying that the chosen materials can be used safety in contact with the ear established.
• Mechanism designed to allow the outer bud to be both easily fitted and readily removed from the device (the device lasts much longer than the outer bud) in a quick and easy way.
• Assess the proper fit of the CAD drawing with the concha and canal, taking into account the data of the ear dimensions of the representative population obtained in Task 3.2 Ear characterization).
• Design and validation of the design of the outer shell and soft buds by means of the users’ opinions, considering ergonomics, comfort, usability and fit.
• Design and Validation of the different sizes (large, medium, small) of the soft bud by means of a representation of 5th to 95th percentile of the population.
In WP4, based on the results from the previous work packages, a functional prototype were produced and tested using digital artificial head HMS III (HEAD Measurement System) by HEAD acoustics. This included objective measurements to check perceived sound and speech intelligibility to allow a validated prototype to be produced. In Task 4.1 we manufactured functional prototypes of the PiezoSelEx device with the piezo elements from the WP1 and WP2 integrated into the device design as a moulded product. The prototypes were later used to carry out acoustic tests in Task 4.2 and 4.
In Task 4.2 we undertook different acoustic lab tests and analysis to validate the prototypes and this were further validated including safety studies of the functional PiezoSelEx prototypes in Task 4.4 using the artificial head HMS III by HEAD Acoustics focusing on evaluation noise reduction.
consisted of establishing the necessary modifications to manufacture the final functional prototype of the PiezoSelEx device, applying modifications to the initial prototypes made in Task 4.1. The improvements were based on the conclusions obtained from the results of the laboratory testing (Task 4.2) and safety validation (Task 4.3).
Analysing the results of the test laboratory testing (Task 4.2) it was concluded that harmful feedback between the receiver piezo element and the emitter part could still exist. This is caused mainly because of the transmission of mechanical vibrations between the two piezo elements through the hard exterior shell. To solve this problem a softer material for the exterior shell of this final prototype was utilised, with the aim to absorb vibrations but keeping rigidity enough to ensure maintenance of its form. The amplifier board used in the previous PiezoSelEx prototype PZ3 and HH4, was also further improved:
Significant Achievements in Work Package 4:
- Manufacture of a set of functional prototypes to be later tested from an acoustic point of view.
- Selection of the optimum manufacture process of the outer shell and the soft bud.
- Methodology to test the PiezoSelEx device from an acoustic point of view and testing under real conditions, which the system will be exposed in practice
- Detect strong and weak points in the prototypes tested and establish the redesign recommendations for the final prototype of the PiezoSelEx device.
- Obtain the noise attenuation of the PiezoSelEx prototypes developed in Task 4.1.
- Propose redesign recommendations for the final prototype of the PiezoSelEx device and improve the design of the PiezoSelEx device from an acoustic point of view by means of the improvement of the outer shell and the electronic amplifier.
- Manufacture a set of functional final prototypes to be later evaluated in WP5
Work Package 5 was concerned with final prototype production, Laborataory validation, User trails and finally leading to review of the data. The final prototype using two piezoelectric elements was found to have an attenuation of below the required level for an effective hearing protection device and the output from the piezo emitter was masked by the external workplace noise. In order to correct these failings, several changes were made to the final optimised prototype as part of Task 5.1 including modification of the ear bud and a change in physical components inside the ear bud itself and amplifier modules. In task 5.2 we tested the Final Prototype and the Optimised Final Prototype. The final prototype using two piezoelectric elements was found to have an attenuation of below the required level for an effective hearing protection device and the output from the piezo emitter was masked by the external workplace noise. In order to correct these failings, several changes were made to the final optimised prototype including modification of the ear bud and a change in physical components inside the ear bud itself. The attenuation of the Optimised Final Prototype was significantly improved over the Final Prototype and the amplification was such that specific noises could be heard preferentially over background noise. The device met the specification laid out in the DoW for the functionality of the prototype. Based on data review from Task 5.4 the consortia have developed a plan for commercialisation of the device, first concentrating on the hearing-impaired market before moving on to the industrial workplace noise marketecifications
. Significant Achievements in Work Package 5:
- Prototype produced to meet noise reduction and band-pass requirements.
- Prototypes are flexible for continued future development of additional frequency band, noise cancellation, and alternate telecoil inputs
- The results from the final optimized design prototype show real promise for a commercial product. In the commercial product, a microphone will be incorporated into the design, which will allow for active noise reduction (ANR) to occur using the Digital Signal Processing (DSP) chip.
- The bulk attenuation of the prototype is similar to other current products on the market although the design allows for a greater range of functionality.
- The updated prototype has been shown to amplify certain frequencies to improve the users’ ability to detect certain sounds such as speech or warning alarms.
- Since the DSP allows manipulation of the amplification spectrum, this can also be changed to suit the environment and the needs of the user.
- A number of necessary and appropriate changes have been identified for the final commercial product which will add significant value to the consortia
- Based on data review the consortia have developed a plan for commercialisation of the device, first concentrating on the hearing-impaired market before moving on to the industrial workplace noise market
Potential Impact:
Exploitation of IP: In the original project outline PiezoSelex was intended to provide active noise reduction by means of multiple piezo pairs working in antiphase, thus reducing the sound perceived by the ear and if required the elements could be turned on or off to suit the users environment. Due to the limited harvestable energy from early modelling, the consortium sought several ways to overcome this issue whilst still having a niche marketable innovative product. These are as outlined in the D6.5 Market Intelligence Report.
The final outcome of the project was to use a bespoke digital signalling processor with multiple channels that could be programmed to the users’ environment. The use of extra channels means that there is the potential of a common frequency modulation (FM) receiver that would broadcast announcements or alarms.
This technology can also be applied to the Hard of hearing market as mentioned in market intelligence report, where the system can be used to amplify frequencies that are bespoke to the users hearing loss and the potential for direct interface or wireless interface into audio sources such as TV, Radio and Bluetooth mobile phones.
The novelty with the End Product is that we believe it is unique as PiezoSelEx will be the first independently programmable in the ear system to be able to provide either active noise reduction/band pass or both whilst having independent channels for receiving FM communication.
Further IP has been created relating to ear characterisation including a database for a representation of 5th-95th percentile of the chosen population that was used for deciding upon the best three sizes of the final prototype in order to provide adequate fitting of 90% of the total population. This IP will be unprotected however will be exploited through publication as research by the creators.
Dissemination to SMEs: To prepare the market for the PiezoSelEx project we have developed a comprehensive dissemination strategy. At the end of the project we have collected a wealth of information on the individual scientific and technological advancement, along with the commercial advantages. By sustaining and promoting networking activities with stakeholders, the dissemination activities encouraged and stimulated the exchange of information – throughout a proactive “top level” contribution - between the research community and the stakeholders as well as among stakeholders themselves.
Dissemination was active throughout the project duration, aiming to gather explicit input and feedback from stakeholders and to share the project findings. The nature of the PiezoSelEx project implied a continuous improvement and update of actions throughout the 24 months, as new opportunities and changes arose.
The dissemination strategy was a two-tiered approach, reaching out to the:
• European/International level: the project included actions, events and instruments able to promote the transfer of information to other stakeholders / institutions / Organisations / researchers of an “integrated package”.
• Local level, the dissemination undertook a wide range of targeted measures so as to maximise the attendance of relevant key local actors, achieving consensus and Transparency among the different target groups.
We plans to hold further dissemination events specifically aimed at SMEs for the PiezoSelEx for the Hard of Hearing market. This event (or series of events) will provide on-site support for institutions concerned about digital preservation and developing sensible long term strategies for access and preservation of electronic materials. The project will bring its knowledge and experience to these events as a way of providing support and hands-on assistance to SMEs within the context of their local situation.
The consortium has identified the following publications to further disseminate the project results:
• The Journal of Material Systems and Structures
• Microelectronics
• Smart Materials Technologies
• The International Journal for Manufacturing Science and Production
• Environmental Health Perspectives.
Articles will be prepared as the project results are validated and sufficient evidence is developed to satisfy the peer review process.
The initial method of dissemination will be via SME mailing lists but this will be supplemented with extensive coverage in E-letters, newsletters, websites, exhibitions and trade publications. As exhibitions and conferences we will target the major events in 2013 and 2014 dealing with noise and noise control:
• Euronoise, the EU conference on noise control
• Internoise – the international congress and exposition on noise control engineering
• ICCV – the international congress on sound and vibration
• EuroRegio – the regional conference and exhibition on sound and vibration sponsored by the European Acoustical Association
Applications for Patents, Trademarks or Registered Designs: DBHI as the exploitation lead on the project has filed a general Intellectual property protection on behalf of the consortium members, in order to safeguard any infringements that may occur during the project duration.
From the onset of the project DBHI have sought to protect all IP that may emerges from the project, however this has been a difficult task due to the nature of the project as during project the technology and application has changed. We have developed a detailed IPR strategy that has taken into consideration all background IPR owned by consortium members to ensure that we can effectively exploit project foreground on a pan-European scale. A full evaluation of patented competitive technologies will be carried out and a template is in place to ensure all novelties are captured prior to patent applications being filed, once we have completed the initial research and development phase which will establish whether the technology is viable. With the use of bespoke digital signalling processor with multiple channels that could be programmed to the users’ environment, the IP relevant to the technical specifications has changed and the IP would be on the application rather than the technology. Market Development: The final outcome of the project was to use a bespoke digital signalling processor with multiple channels that could be programmed to the users’ environment. The use of extra channels means that there is the potential of a common frequency modulation (FM) receiver that would broadcast announcements or alarms. This technology can now also be applied to the Hard of Hearing (PiezoSelEx HH), market as mentioned in market intelligence report, where the system can be used to amplify frequencies that are bespoke to the users hearing loss and the potential for direct interface or wireless interface into audio sources such as TV, Radio and Bluetooth mobile phones. There are lots of potential market options beyond manufacturing and transport including:
• Recreational (sleeping, travel, music)
• Mining
• Military
• Agriculture
• Professional Musicians
• Utilities
There is a need to identify key links into each market and start to build contacts and routes to market (e.g. Boots etc. for recreational). It is also necessary to check regulatory/legislative conditions and requirements for industry noise reduction schemes.
Communications and Promotion: A stakeholders’ database was consolidated, improved and updated throughout the project. The database covered a record of more than 100 stakeholders across Europe representing the target audience for project dissemination activities. They all had a privileged access to project results, such as minutes of meetings and workshops, newsletters, forum entrance from the website, website updates, etc. The set up of the PiezoSelEx Community allowed the Consortium to establish day-to-day contacts with relevant Transport and Industry key actors and representatives from EU Member States. It also ensured that a high level team of experts, active and committed on the field, was closely associated to the project input and final validation at different stages. The Community database was the backbone of the PiezoSelEx Project. This database was structured by segmenting the stakeholders according to the PiezoSelEx dealing with transport and manufacturing industry in order to tailor the dissemination activities as well as identify which stakeholder involve at different project stage (and according to project’s requirements).
To promote PiezoSelEx, the consortium created a website – see http://www.piezoselex.eu. The purpose of the website is two-fold. Firstly the public can be guided to the site which promotes the product, the consortium members and the fact that the work be undertaken is an EC-funded project. The second use for the website is as a communications tool between the consortium members, this can be utilised as a drop box where any member can leave research documents for others to access. This is achieved by a secure login facility which is password protected
Promotional Banners: The consortium designed and produced an exhibition display banner, which has been used for promoting the product by the consortium at different events. Using this banner it can be left unattended with promotional flyers such as the case study or as part of an exhibition on a manned stand.
Case Study: Were created to draw attention to the problem of noise induced hearing loss and then propose the solution of PiezoSelEx.
The consortium has designed several eye-catching presentations that encapsulate the purpose of the project. including specific presentation to promote the product for the new Hard of hearing emerging market for PiezoSelEx, .
Potential Impact: As discussed elsewhere in the report the original concept has changed to some extent and with the introduction of the DSP Chipset and the attenuation of the soft bud has meant that we can exploit the versatility of the chipset, the channels it offers and the programmability of the chip for both the targeted market of Ear Protection as well as a potential new market for Hard of Hearing as follows:
Ear Protection
The ear defender market in 2007 was valued by Frost and Sullivan at €60 million and is forecast to grow to €71 million by 2014, a growth rate of 2.5% per annum. Much of this growth is forecast to come from those ear defenders featuring electronic and communications functions. Currently these sectors account for 11% each respectively with passive types being supplied in nearly four out of five cases. Given the level of dissatisfaction with headphone-style ear defenders – heavy on the head, hot to wear, difficult to use with other personal protective equipment (ppe) such as glasses – it is not surprising much of the focus is now on innovative designs offering noise cancelling benefits to users
Over a five year period we expect to gain 5% of the ear defender market equal to 365,000 units but as the clear benefits of the PiezoSelEx product become apparent more substantial penetration into the ear plug sector will increase this to 750,000 units in the 5 year period. An estimated one third of Europe's workers or 20 million people are exposed to high levels of noise for more than a quarter of their working time The PiezoSelEx product with its very well defined clear benefits will enable us to increase our sales by between 40 and 50% over those generated by share shift within the current market, expanding sales to 1.25 million units after 5 years with a total market value of €15 million
Hard of Hearing Market
55 million people in the EU have a hearing loss, 1 in 6 wear hearing aids, Over 45 million struggle either ignoring their loss as there is stigma attached to the subject, they choose to ignore it or cannot afford instruments. PiezoSelEx can benefit not only existing hearing aid users but also the 45 million that ignore their loss. The system would be ideally priced at €300, placing it at the lower end of the Existing FM Market. Furthermore PiezoSelEx is the first programmable directional assistive listening device capable of integrating with all Bluetooth and FM transmitters within frequency and first Assistive listening device that can be programmed by the user to their specific hearing loss.
PiezoSelEx Transmitter can be used both with the new emerging market of Bluetooth Hearing Instruments and with an induction loop or noise cancelling Headphones as a TV Listener.
Manufacturing software and maintenance target<€100 per unit, with a distributor price €150 and .05% (5 in every thousand) target penetration in three years of hearing aid market alone would result in €6,875,000 total turnover. With EPITDA of €2,291,666, a penetration of the non-hearing aid user market target of .05% (5 in every ten thousand) = €3,375,000 if sold indirect through distribution or €6,750,000 if sold via ecommerce. With EBITDA €1,145,83 indirect or €4,455,000 direct ecommerce and total units sold in three years 68,750
Socio-Economic and Societal Implications
There is no doubt that noise causes or contributes to a number of severe health consequences. Noise exposure has also been known to induce tinnitus, vasoconstriction and other cardiovascular impacts. Beyond these effects, elevated noise levels can create stress, increase workplace accident rates, and stimulate aggression and other anti-social behaviours. Improved protection through PiezoSelEx potentially has a strong beneficial impact on peoples’ health
List of Websites:
THE PROJECT WEB PORTAL
The website is available to the Project Consortium and the Home Page is also available to the General Public. Visit PIEZOSELEX at http://www.piezoselex.eu/
Contact Details:
Andrew Birkbeck
GBA Services Ltd.
Tel: +447809522004
Fax: +441772 816600
E-mail: andrew.birbeck@gbaservices.co.uk
PiezoSelEx is a two-year project funded by the European Commission’s Framework 7 Programme, within the ‘Research for SMEs’ scheme. The PiezoSelEx consortium is made up of a well balanced team of organisations who have been selected on the basis of their expertise in fields that are complimentary to the projects development. The specialist knowledge of each consortium member covers a number of subject areas including piezo material manufacture, piezo material science and research, medical device development and manufacture and the hearing loss industry.
There are 700,000 SMEs in the key industry sectors of manufacturing and transport across Europe currently dealing with reduced productivity due to Noise Induced hearing Loss (NIHL). It is estimated that 572,000 people are diagnosed as suffering from occupational NIHL resulting in an estimated loss per annum of €345M to these key business areas.
Although EU legislation requires employers to provide suitable ear protection, the view of many employees as that due to a number of issues they do not wear them. The two key issues cited are:
• The impact on general hearing capability, i.e. conversation and warning signals, for example fire alarms.
• Incompatibility with other items of safety equipment, i.e. glasses, helmets, breathing apparatus.
The problem of Noise Induced Hearing Loss (NIHL) in the work place is a problem for a vast number of SMEs and European workers in general, particularly those in the manufacturing and transport sectors. NIHL results in reduced productivity from lost work days, insurance claims and potential early retirement due to disability. Current EU legislation requires employers to provide suitable ear protection for workers exposed to high levels of noise. However, worker compliance in hearing conservation programs often is low. The attitude of many workers is that the use of hearing protection impairs hearing capability. Therefore a suitable alternative to existing ear protection is needed – one allowing specific ranges of sound frequencies (i.e. those within the range of speech and alarms) to be heard whilst significantly reducing other potentiallyharmful noise frequencies.
In summary the PiezoSelEx device will:
• help promote productivity due to easier communication
• reduce the risk of NIHL by reducing noise levels
• contribute to a more comfortable work environment due to perceived lower levels of noise
• reduce employee absenteeism due to increased wearer comfort and a reduction in NIHL
• contribute to a safer working environment as warning signals such as fire alarms and local machine alarms will be easier to hear.
There are also a number of wider benefits for Europe. In addition to working environments currently protected by legislation, our device may provide a driver to enforce new legislations, particularly in the entertainment industry.
The final outcome of the project was to use a bespoke digital signalling processor with multiple channels that could be programmed to the users’ environment. The use of extra channels means that there is the potential of a common frequency modulation (FM) receiver that would broadcast announcements or alarms.
This technology can also be applied to the Hard of hearing market as mentioned, where the system can be used to amplify frequencies that are bespoke to the users hearing loss and the potential for direct interface or wireless interface into audio sources such as TV, Radio and Bluetooth mobile phones. We believe that PiezoSelEx will be the first independently programmable in the ear system to be able to provide either active noise reduction/band pass or both whilst having independent channels for receiving FM communication.
Project Context and Objectives:
The issue of Noise Induced Hearing Loss (NIHL) in the workplace is a problem for a vast number of SMEs and European workers in general, particularly those in the manufacturing and transport sectors. NIHL results in reduced productivity from lost work days, insurance claims and potential early retirement due to disability. Current European Union (EU) legislation requires employers to provide suitable ear protection for workers exposed to high levels of noise. However, worker compliance in hearing conservation programs is often low. The attitude of many workers is that the use of hearing protection impairs hearing capability. Therefore a suitable alternative to existing ear protection is needed – one allowing specific ranges of sound frequencies (i.e. those within the range of speech and alarms) to be heard whilst significantly reducing other potentially harmful noise frequencies
There are 700,000 SMEs in the key industry sectors of manufacturing and transport across Europe currently dealing with reduced productivity due to Noise Induced hearing Loss (NIHL). It is estimated that 572,000 people are diagnosed as suffering from occupational NIHL resulting in an estimated loss per annum of €345M to these key business areas.
Although EU legislation requires employers to provide suitable ear protection, the view of many employees as that due to a number of issues they do not wear them. The two key issues cited are:
• The impact on general hearing capability, i.e. conversation and warning signals, for example fire alarms.
• Incompatibility with other items of safety equipment, i.e. glasses, helmets, breathing apparatus.
In summary the PiezoSelEx device will:
• help promote productivity due to easier communication
• reduce the risk of NIHL by reducing noise levels
• contribute to a more comfortable work environment due to perceived lower levels of noise
• reduce employee absenteeism due to increased wearer comfort and a reduction in NIHL
• contribute to a safer working environment as warning signals such as fire alarms and local machine alarms will be easier to hear.
There are also a number of wider benefits for Europe. In addition to working environments currently protected by legislation, our device may provide a driver to enforce new legislations, particularly in the entertainment industry.
The link between exposure to noise and damage to hearing is well known and internationally accepted. It is clear that noise at work poses a serious but often underestimated threat to millions of European workers. An estimated one third of Europe’s workers (more than 60 million people) are exposed to high levels of noise for more than a quarter of their working time. According to European survey results 7% of European workers consider that work affects their health in terms of hearing disorders. Hearing impaired individuals may suffer from social, psychological and physical problems; they are twice as likely to be unemployed and average earnings are 50-70% of those achieved by non sufferers.
The EU considers hearing impairment as one of the biggest health and social issues. Estimated annual expenditure as a result of hearing loss is €106 billion (€260 per EU citizen) and societal costs are estimated at €92 billion/year8. Current ear defenders attempt to reduce the financial impact by protecting workers from noise, but clearly don’t prevent all cases.
According to the European Agency for Safety and Health at Work, about 7% of ALL workers in the EU-15 members states in 2001 were affected by occupational NIHL. Thus, with 65.9 million people in the EU-27 employed in 2008 , 4.4 million workers across the EU are affected by NIHL. Over-exposure to noise at work results in increased levels of absenteeism and early retirement, resulting in decreased company productivity and thus competitiveness.
The PiezoSelEx device is able to contain the required functionality, yet be small enough to be contained within an in-ear device ensuring compatibility with other essential items of safety equipment such as helmets and goggles and be comfortable for wearers to use for extended periods of time.
PiezoSelEx device will therefore meet an important need for the European employees where exposure to noise, particularly in the important SME dominated industries of manufacturing and transport, causes problems for a significant proportion of the workforce. Ear defenders currently on the market do not fully satisfy the workers needs particularly with regard to effective noise cancellation whilst still enabling them to communicate or hear alarms and are not very comfortable to wear. Training on how to wear them correctly is frequently inadequate and workers are often reluctant to wear them. The PiezoSelEx will satisfy these needs improving both the effectiveness and the ability to communicate with thoughtful design providing the comfort factors workers need to encourage regular use. The elimination of large batteries and circuit boards will enable our device to be made small enough and light enough to fit in the ear. The device will be marketed at an affordable price with a negligible increase over a standard basic ear defender.
The first 14 months was devoted to both the modelling and selection of piezo materials and the ergonomic design of the earplugs. Once the design stage was sufficiently underway, a simple prototype was built and tested. Miniaturisation of the prototype was then incorporated into the design. Validation studies and laboratory testing were then undertaken in preparation for user trials. The final 6 months was dedicated to the user trials to demonstrate the feasibility and economics of the prototype technology in situ.
The first stage of the project and WP1 therefore was to carry out the characterization of the various Piezo materials available. This enabled us to determine the optimum type for collecting airborne sound and using the electrical energy generated to power the second, sound cancelling, elements.
The proof of concept was demonstrated in WP2 in which the effectiveness of noise generation against predictions was assessed and a working model built to demonstrate noise cancelling characteristics over a range of frequencies in a semi miniaturised model.
A detailed analysis of the in-ear defender market in Europe was undertaken looking at a wide range of parameters and expectations for PiezoSelEx was established through questionnaires and focus group meetings as part of WP3. The information obtained was combined to specify a design which took into account bio and environmental compatibility and also to ensure compatibility and non interference with the piezo elements. The resulting CAD drawing was used to produce prototypes in each of the specified sizes to assess comfort and fit for users in the 5th-95th percentile of the population.
Final prototype build, validation and user trials were undertaken in WP4 and WP5. In WP5 we also coordinated user trials and established feedback with a number of volunteers
The final prototype using two piezoelectric elements was found to have an attenuation of below the required level for an effective hearing protection device and the output from the piezo emitter was masked by the external workplace noise.(See Task 5.2 below)
In order to correct these failings, several changes were made to the final optimised prototype including modification of the ear bud and a change in physical components inside the ear bud itself and amplifier modules.
With the introduction of the DSP Chipset and the attenuation of the soft bud has meant that we can exploit the versatility of the chipset, the channels it offers and the programmability of the chip for both the targeted market of Ear Protection as well as a potential new market for Hard of Hearing. For the latter case, 55 million people in the EU have a hearing loss, 1 in 6 wear hearing aids, Over 45 million struggle either ignoring their loss as there is stigma attached to the subject, they choose to ignore it or cannot afford instruments. PiezoSelEx can benefit not only existing hearing aid users but also the 45 million that ignore their loss. The system would be ideally priced at €300, placing it at the lower end of the Existing FM Market. Furthermore PiezoSelEx is the first programmable directional assistive listening device capable of integrating with all Bluetooth and FM transmitters within frequency and first Assistive listening device that can be programmed by the user to their specific hearing loss.
PiezoSelEx Transmitter can be used both with the new emerging market of Bluetooth Hearing Instruments and with an induction loop or noise cancelling Headphones as a TV Listener.
Manufacturing software and maintenance target<€100 per unit, with a distributor price €150 and .05% (5 in every thousand) target penetration in three years of hearing aid market alone would result in €6,875,000 total turnover. With EPITDA of €2,291,666, a penetration of the non-hearing aid user market target of .05% (5 in every ten thousand) = €3,375,000 if sold indirect through distribution or €6,750,000 if sold via ecommerce. With EBITDA €1,145,83 indirect or €4,455,000 direct ecommerce and total units sold in three years 68,750
Project Results:
PiezoSelEx was split into four phases, each containing defined work packages (WPs), with associated tasks and deliverables.
• Phase 1 (WP 1) – Months 0 - 6:
Review of available airborne sound and current ear defender state of the art. Using advanced modelling to carry out a characterisation of the various piezo materials available to determine the most suitable material. Use this modelling to generate a theoretical design for the PiezoSelEx solution.
• Phase 2 (WP 2 & 3) – Months 7 - 14:
This was mainly development phase. Here the theoretical design from WP1 was initially progressed into a physical proof of concept before miniaturising to a final ear defender prototype solution.
In parallel, ergonomic investigation and design were completed to provide the method of encasing the physical ear defender and providing a suitable fit for the 5th – 95th percentile of the population.
• Phase 3 (WP 4 & 5) – Months 15 - 24:
This phase was the manufacturing of the final prototype design generated in WPs 3 & 4 and evaluation against the requirements for the project. The evaluation also included user trials to provide feedback from real people in real environments.
• Phase 4 (WP 6 & 7) – Months 0 - 24:
This phase ran for the duration of the project. It covered the exploitation and dissemination strategy for PiezoSelEx, including managing any appropriate IPR and patents.
WP1 was related to Modelling and Selection of Piezo Materials – by undertaking characterization of the various Piezo materials available. This enabled us to determine the optimum type for collecting airborne sound and using the electrical energy generated to power the second, sound cancelling, elements. Task 1.1 Piezo material review, purpose of which was to review the energy budget for the device, how much energy could be harvested, and what could be achieved with the available energy, using the most appropriate piezoelectric materials for an in ear defender application.
Initially the requirements of the device were refined in order to clarify the scope of the design. At this review it was decided that some of the most important factors were that the device should be in-ear, i.e. not impede wearing other equipment such as glasses or helmets, battery-less and with no wiring etc. protruding from the ear, and low cost. A patent review revealed that there were only a few devices that used piezoelectric materials in hearing related applications and no devices used piezoelectric as both an energy harvester/microphone and emitter/loudspeaker. The requirement of Task 1.2 Device Design & proof of Concept Modelling, were to develop designs for the device for refinement in task 1.3.
The initial scope was for multiple pairs of receiving and emitting piezoelectric elements, however given the space requirements it was felt that at this stage the focus should be on using a single pair to prove the concept. The device design needed to accommodate conflicting requirements, a small volume in order to fit inside the ear, and large area to harvest acoustic energy and maintain an audio frequency bandwidth.
The energy budget had revealed that there was little scope for active solutions, and energy harvesting with storage would be wasteful in energy and space terms. For this reason the only viable solution was to use resonance to maximise the response of the system, and this was the approach taken thorough the rest of the design stages. Models, semi-analytical and finite element, were developed to look at the effects of connecting two piezoelectric materials back to back in an acoustic application. Initial results using solid piezo materials showed that PZT ceramic materials had a high sensitivity but poor coupling to air, whereas polymeric PVDF had better coupling to air but much reduced sensitivity. Additionally, a review of audio frequency applications using piezoelectric materials showed the most appropriate device was to use a flexural mode by backing a disc of piezoelectric with passive material. Other ideas developed to increase coupling to air of the receiving piezoelectric included adding flared horns or a Helmholtz resonator.
Task 1.3 relating to Final Piezo material selection was to consolidate the research in tasks 1 and 2 in order to provide a blueprint for the building and testing of a prototype device in Work Package 2. The finite element model was developed to include a Helmholtz resonator at the input stage, two electrically connected piezoelectric discs, each with a backing material, and the output piezoelectric acoustically coupled to a model of the ear canal. This model was optimised to give the maximum acoustic output at the ear canal, for a 1Pa incident acoustic pressure. The optimisation included a range of materials, their typical dimensions and also limited dimensions to a volume that fitted within the original device specifications. The optimisations showed that using a PMN-PT receiver, and a PVDF emitter, a signal at 2kHz could pass through the device with zero loss, and using a PZT receiver only a 15dB loss is seen
Significant Achievements in Work Package 1:
• The energy budget had revealed that there was little scope for active solutions, and energy harvesting with storage would be wasteful in energy and space terms. For this reason the only viable solution is to use resonance to maximise the response of the system
• The energy budget for the device based on purely piezo materials has been identified
• Blueprint for the building and testing of a prototype device in work package 2 provided and consist of using a PMN-PT receiver, and a PVDF emitter, a signal at 2kHz could pass through the device with zero loss, and using a PZT receiver only a 15dB loss is seen.
WP2 was concerned with simple prototype build and miniaturisation , in which we demonstrated the proof of concept by measuring the effectiveness of noise generation against predictions. The study was extended to investigate the frequency selective components necessary to ensure speech and alarms can be heard.
The research undertaken in WP1 identified that the current proposal to use multiple sets of piezo pairs to work in anti-phase and cancel work place noise is not a viable solution. The main reason for this is that it has been shown through modelling, that using multiple pairs would not allow the harvesting of sufficient energy to power the system.
The proposed change was to still use piezo pairs, so keeping to the concept of the system and the project, but to use a single pair which, when used in conjunction with a Helm-Holtz resonator on the receiver, will be able to harvest sufficient energy. As only a single pair is to be used this needs to be selected to work at the voice frequency band. The remaining noise frequencies was eliminated by the use of a passive block.
Task 2.1 Prototype build and performance measurement using test system. The testing set-up was based around a planar wave tube manufactured by Bruel & Kjaer. This allowed the material to be tested to be fitted at one end of the tube and the actuation or measurement device at the other
Task 2.2 Frequency selection optimisation in which we identified the methodology for selecting most appropriate frequencies for the given work environment in which the receiver/emitter system will be used. Based on the concept and requirements defined for the system in WP1, the solution proposed was based on all previous requirements that have been put forth in previous tasks and WPs; Task 2.3 Miniaturisation issues and prototype, in which we miniaturized the receiver/emitter system used in the proof-of-concept (laboratory level) using commercial components following the design guidelines outlined in WP1 and taking into consideration the limitations imposed by time and the commercially available components
Significant Achievements in Work Package 2:
- The ability to tune the working frequency of the receiver in three different ways.
- The ability to adjust the emission frequency of the emitter:
o Designing an emitter with the minimum voltage input possible, so as to increase the number of potential working frequencies of the system.
o The PVDF emission frequencies can be tuned by changing the radius of curvature of the PVDF membrane.
- The proof of concept of the PiezoSeLex concept and its miniaturisation has been carried out successfully.
- A functional characterisation of this device was proposed for WP3 that addresses those aspects that have not been possible to do in WP2 such as the material used to encapsulate the ensemble receiver/passive material/emitter, which should improve the sound attenuation of the environment, and those aspects related to the ergonomic design of the prototype.
In WP3 the focus groups and questionnaires analysis provided the main design parameters that should be included in the device. A data base with ear dimensions allowed us to select the three sizes of the final prototype in order to provide adequate fitting of 90% of the total population. Within this task we also developed a methodology for enabling ear dimensions to be taken and a pre-production validation to assess overall ergonomics of the device. Task 3.1: Analysis of focus groups and questionnaire was aimed to gather information from end-users about current situation, expectancies and requirements for the PiezoSelEx device from current hearing protection users across Europe. Task 3.2: Ear characterisation’s main objective was determining variations in ear dimensions across age, gender and regions in order to ensure a design for the PiezoSelEx device that fits the 5th - 95th percentile of the population. Task 3.3 was related to material assessment in which the focus was to establish and select the best materials for the PiezoSelEx device consisting of the proposed outer shell (fix component that contains the Piezo elements) and a soft bud (removable component).
In the design process, an important requirement, pointed by users and experts, has been the easy replacement of soft buds. For this reason, one of the main points in Task 3.4 was focused on the design of the mechanism to ensure easy replacement of soft buds as well as be as small as possible to maintain the user´s comfort. In this task, the soft bud concept in three sizes were designed so that when placed over the device they merge to create the overall sizing requirements to fit users in the 5th-95th percentile. The selection of soft bud size was also determined from the ear characterization developed in Task 3.2. In Task 3.5 we created a fully CAD drawing of the fully conceptual design of the soft bud (foam and mushroom shape) as well as the outer shell of the PiezoSelEx device
Significant Achievements in Work Package 3:
• The ear protector that workers usually wear while working established.
• The hearing protector problems including the advantages, comfort and effectiveness perceived by the respondents of the ear protector they currently use identified.
• Ear protector selecting criteria when choosing ear protection equipment established.
• List of requirements that should be included in the new system PiezoSelEx device to make it safe and ergonomic for hearing protection’s users established
• Acquisition of a representative full range of Europeans exposed to occupational noise, where factors in choosing individuals include age, gender and geographical location.
• A reliable and safe method of ear shape acquisition and the quantitative shape characterization defined.
• Method to align the individual shapes that optimizes the internal volume where the filters will be located established.
• Internal volume to set up the dimensions of the available space inside the outer ear modelled.
• Established three different sizes (small, medium and large) for the device based on the various ears dimensions obtained from the study including the best three sizes of the device that assure an adequate fitting of 90% of the total population.
• Biocompatibility in the selection of the materials, guarantying that the chosen materials can be used safety in contact with the ear established.
• Mechanism designed to allow the outer bud to be both easily fitted and readily removed from the device (the device lasts much longer than the outer bud) in a quick and easy way.
• Assess the proper fit of the CAD drawing with the concha and canal, taking into account the data of the ear dimensions of the representative population obtained in Task 3.2 Ear characterization).
• Design and validation of the design of the outer shell and soft buds by means of the users’ opinions, considering ergonomics, comfort, usability and fit.
• Design and Validation of the different sizes (large, medium, small) of the soft bud by means of a representation of 5th to 95th percentile of the population.
In WP4, based on the results from the previous work packages, a functional prototype were produced and tested using digital artificial head HMS III (HEAD Measurement System) by HEAD acoustics. This included objective measurements to check perceived sound and speech intelligibility to allow a validated prototype to be produced. In Task 4.1 we manufactured functional prototypes of the PiezoSelEx device with the piezo elements from the WP1 and WP2 integrated into the device design as a moulded product. The prototypes were later used to carry out acoustic tests in Task 4.2 and 4.
In Task 4.2 we undertook different acoustic lab tests and analysis to validate the prototypes and this were further validated including safety studies of the functional PiezoSelEx prototypes in Task 4.4 using the artificial head HMS III by HEAD Acoustics focusing on evaluation noise reduction.
consisted of establishing the necessary modifications to manufacture the final functional prototype of the PiezoSelEx device, applying modifications to the initial prototypes made in Task 4.1. The improvements were based on the conclusions obtained from the results of the laboratory testing (Task 4.2) and safety validation (Task 4.3).
Analysing the results of the test laboratory testing (Task 4.2) it was concluded that harmful feedback between the receiver piezo element and the emitter part could still exist. This is caused mainly because of the transmission of mechanical vibrations between the two piezo elements through the hard exterior shell. To solve this problem a softer material for the exterior shell of this final prototype was utilised, with the aim to absorb vibrations but keeping rigidity enough to ensure maintenance of its form. The amplifier board used in the previous PiezoSelEx prototype PZ3 and HH4, was also further improved:
Significant Achievements in Work Package 4:
- Manufacture of a set of functional prototypes to be later tested from an acoustic point of view.
- Selection of the optimum manufacture process of the outer shell and the soft bud.
- Methodology to test the PiezoSelEx device from an acoustic point of view and testing under real conditions, which the system will be exposed in practice
- Detect strong and weak points in the prototypes tested and establish the redesign recommendations for the final prototype of the PiezoSelEx device.
- Obtain the noise attenuation of the PiezoSelEx prototypes developed in Task 4.1.
- Propose redesign recommendations for the final prototype of the PiezoSelEx device and improve the design of the PiezoSelEx device from an acoustic point of view by means of the improvement of the outer shell and the electronic amplifier.
- Manufacture a set of functional final prototypes to be later evaluated in WP5
Work Package 5 was concerned with final prototype production, Laborataory validation, User trails and finally leading to review of the data. The final prototype using two piezoelectric elements was found to have an attenuation of below the required level for an effective hearing protection device and the output from the piezo emitter was masked by the external workplace noise. In order to correct these failings, several changes were made to the final optimised prototype as part of Task 5.1 including modification of the ear bud and a change in physical components inside the ear bud itself and amplifier modules. In task 5.2 we tested the Final Prototype and the Optimised Final Prototype. The final prototype using two piezoelectric elements was found to have an attenuation of below the required level for an effective hearing protection device and the output from the piezo emitter was masked by the external workplace noise. In order to correct these failings, several changes were made to the final optimised prototype including modification of the ear bud and a change in physical components inside the ear bud itself. The attenuation of the Optimised Final Prototype was significantly improved over the Final Prototype and the amplification was such that specific noises could be heard preferentially over background noise. The device met the specification laid out in the DoW for the functionality of the prototype. Based on data review from Task 5.4 the consortia have developed a plan for commercialisation of the device, first concentrating on the hearing-impaired market before moving on to the industrial workplace noise marketecifications
. Significant Achievements in Work Package 5:
- Prototype produced to meet noise reduction and band-pass requirements.
- Prototypes are flexible for continued future development of additional frequency band, noise cancellation, and alternate telecoil inputs
- The results from the final optimized design prototype show real promise for a commercial product. In the commercial product, a microphone will be incorporated into the design, which will allow for active noise reduction (ANR) to occur using the Digital Signal Processing (DSP) chip.
- The bulk attenuation of the prototype is similar to other current products on the market although the design allows for a greater range of functionality.
- The updated prototype has been shown to amplify certain frequencies to improve the users’ ability to detect certain sounds such as speech or warning alarms.
- Since the DSP allows manipulation of the amplification spectrum, this can also be changed to suit the environment and the needs of the user.
- A number of necessary and appropriate changes have been identified for the final commercial product which will add significant value to the consortia
- Based on data review the consortia have developed a plan for commercialisation of the device, first concentrating on the hearing-impaired market before moving on to the industrial workplace noise market
Potential Impact:
Exploitation of IP: In the original project outline PiezoSelex was intended to provide active noise reduction by means of multiple piezo pairs working in antiphase, thus reducing the sound perceived by the ear and if required the elements could be turned on or off to suit the users environment. Due to the limited harvestable energy from early modelling, the consortium sought several ways to overcome this issue whilst still having a niche marketable innovative product. These are as outlined in the D6.5 Market Intelligence Report.
The final outcome of the project was to use a bespoke digital signalling processor with multiple channels that could be programmed to the users’ environment. The use of extra channels means that there is the potential of a common frequency modulation (FM) receiver that would broadcast announcements or alarms.
This technology can also be applied to the Hard of hearing market as mentioned in market intelligence report, where the system can be used to amplify frequencies that are bespoke to the users hearing loss and the potential for direct interface or wireless interface into audio sources such as TV, Radio and Bluetooth mobile phones.
The novelty with the End Product is that we believe it is unique as PiezoSelEx will be the first independently programmable in the ear system to be able to provide either active noise reduction/band pass or both whilst having independent channels for receiving FM communication.
Further IP has been created relating to ear characterisation including a database for a representation of 5th-95th percentile of the chosen population that was used for deciding upon the best three sizes of the final prototype in order to provide adequate fitting of 90% of the total population. This IP will be unprotected however will be exploited through publication as research by the creators.
Dissemination to SMEs: To prepare the market for the PiezoSelEx project we have developed a comprehensive dissemination strategy. At the end of the project we have collected a wealth of information on the individual scientific and technological advancement, along with the commercial advantages. By sustaining and promoting networking activities with stakeholders, the dissemination activities encouraged and stimulated the exchange of information – throughout a proactive “top level” contribution - between the research community and the stakeholders as well as among stakeholders themselves.
Dissemination was active throughout the project duration, aiming to gather explicit input and feedback from stakeholders and to share the project findings. The nature of the PiezoSelEx project implied a continuous improvement and update of actions throughout the 24 months, as new opportunities and changes arose.
The dissemination strategy was a two-tiered approach, reaching out to the:
• European/International level: the project included actions, events and instruments able to promote the transfer of information to other stakeholders / institutions / Organisations / researchers of an “integrated package”.
• Local level, the dissemination undertook a wide range of targeted measures so as to maximise the attendance of relevant key local actors, achieving consensus and Transparency among the different target groups.
We plans to hold further dissemination events specifically aimed at SMEs for the PiezoSelEx for the Hard of Hearing market. This event (or series of events) will provide on-site support for institutions concerned about digital preservation and developing sensible long term strategies for access and preservation of electronic materials. The project will bring its knowledge and experience to these events as a way of providing support and hands-on assistance to SMEs within the context of their local situation.
The consortium has identified the following publications to further disseminate the project results:
• The Journal of Material Systems and Structures
• Microelectronics
• Smart Materials Technologies
• The International Journal for Manufacturing Science and Production
• Environmental Health Perspectives.
Articles will be prepared as the project results are validated and sufficient evidence is developed to satisfy the peer review process.
The initial method of dissemination will be via SME mailing lists but this will be supplemented with extensive coverage in E-letters, newsletters, websites, exhibitions and trade publications. As exhibitions and conferences we will target the major events in 2013 and 2014 dealing with noise and noise control:
• Euronoise, the EU conference on noise control
• Internoise – the international congress and exposition on noise control engineering
• ICCV – the international congress on sound and vibration
• EuroRegio – the regional conference and exhibition on sound and vibration sponsored by the European Acoustical Association
Applications for Patents, Trademarks or Registered Designs: DBHI as the exploitation lead on the project has filed a general Intellectual property protection on behalf of the consortium members, in order to safeguard any infringements that may occur during the project duration.
From the onset of the project DBHI have sought to protect all IP that may emerges from the project, however this has been a difficult task due to the nature of the project as during project the technology and application has changed. We have developed a detailed IPR strategy that has taken into consideration all background IPR owned by consortium members to ensure that we can effectively exploit project foreground on a pan-European scale. A full evaluation of patented competitive technologies will be carried out and a template is in place to ensure all novelties are captured prior to patent applications being filed, once we have completed the initial research and development phase which will establish whether the technology is viable. With the use of bespoke digital signalling processor with multiple channels that could be programmed to the users’ environment, the IP relevant to the technical specifications has changed and the IP would be on the application rather than the technology. Market Development: The final outcome of the project was to use a bespoke digital signalling processor with multiple channels that could be programmed to the users’ environment. The use of extra channels means that there is the potential of a common frequency modulation (FM) receiver that would broadcast announcements or alarms. This technology can now also be applied to the Hard of Hearing (PiezoSelEx HH), market as mentioned in market intelligence report, where the system can be used to amplify frequencies that are bespoke to the users hearing loss and the potential for direct interface or wireless interface into audio sources such as TV, Radio and Bluetooth mobile phones. There are lots of potential market options beyond manufacturing and transport including:
• Recreational (sleeping, travel, music)
• Mining
• Military
• Agriculture
• Professional Musicians
• Utilities
There is a need to identify key links into each market and start to build contacts and routes to market (e.g. Boots etc. for recreational). It is also necessary to check regulatory/legislative conditions and requirements for industry noise reduction schemes.
Communications and Promotion: A stakeholders’ database was consolidated, improved and updated throughout the project. The database covered a record of more than 100 stakeholders across Europe representing the target audience for project dissemination activities. They all had a privileged access to project results, such as minutes of meetings and workshops, newsletters, forum entrance from the website, website updates, etc. The set up of the PiezoSelEx Community allowed the Consortium to establish day-to-day contacts with relevant Transport and Industry key actors and representatives from EU Member States. It also ensured that a high level team of experts, active and committed on the field, was closely associated to the project input and final validation at different stages. The Community database was the backbone of the PiezoSelEx Project. This database was structured by segmenting the stakeholders according to the PiezoSelEx dealing with transport and manufacturing industry in order to tailor the dissemination activities as well as identify which stakeholder involve at different project stage (and according to project’s requirements).
To promote PiezoSelEx, the consortium created a website – see http://www.piezoselex.eu. The purpose of the website is two-fold. Firstly the public can be guided to the site which promotes the product, the consortium members and the fact that the work be undertaken is an EC-funded project. The second use for the website is as a communications tool between the consortium members, this can be utilised as a drop box where any member can leave research documents for others to access. This is achieved by a secure login facility which is password protected
Promotional Banners: The consortium designed and produced an exhibition display banner, which has been used for promoting the product by the consortium at different events. Using this banner it can be left unattended with promotional flyers such as the case study or as part of an exhibition on a manned stand.
Case Study: Were created to draw attention to the problem of noise induced hearing loss and then propose the solution of PiezoSelEx.
The consortium has designed several eye-catching presentations that encapsulate the purpose of the project. including specific presentation to promote the product for the new Hard of hearing emerging market for PiezoSelEx, .
Potential Impact: As discussed elsewhere in the report the original concept has changed to some extent and with the introduction of the DSP Chipset and the attenuation of the soft bud has meant that we can exploit the versatility of the chipset, the channels it offers and the programmability of the chip for both the targeted market of Ear Protection as well as a potential new market for Hard of Hearing as follows:
Ear Protection
The ear defender market in 2007 was valued by Frost and Sullivan at €60 million and is forecast to grow to €71 million by 2014, a growth rate of 2.5% per annum. Much of this growth is forecast to come from those ear defenders featuring electronic and communications functions. Currently these sectors account for 11% each respectively with passive types being supplied in nearly four out of five cases. Given the level of dissatisfaction with headphone-style ear defenders – heavy on the head, hot to wear, difficult to use with other personal protective equipment (ppe) such as glasses – it is not surprising much of the focus is now on innovative designs offering noise cancelling benefits to users
Over a five year period we expect to gain 5% of the ear defender market equal to 365,000 units but as the clear benefits of the PiezoSelEx product become apparent more substantial penetration into the ear plug sector will increase this to 750,000 units in the 5 year period. An estimated one third of Europe's workers or 20 million people are exposed to high levels of noise for more than a quarter of their working time The PiezoSelEx product with its very well defined clear benefits will enable us to increase our sales by between 40 and 50% over those generated by share shift within the current market, expanding sales to 1.25 million units after 5 years with a total market value of €15 million
Hard of Hearing Market
55 million people in the EU have a hearing loss, 1 in 6 wear hearing aids, Over 45 million struggle either ignoring their loss as there is stigma attached to the subject, they choose to ignore it or cannot afford instruments. PiezoSelEx can benefit not only existing hearing aid users but also the 45 million that ignore their loss. The system would be ideally priced at €300, placing it at the lower end of the Existing FM Market. Furthermore PiezoSelEx is the first programmable directional assistive listening device capable of integrating with all Bluetooth and FM transmitters within frequency and first Assistive listening device that can be programmed by the user to their specific hearing loss.
PiezoSelEx Transmitter can be used both with the new emerging market of Bluetooth Hearing Instruments and with an induction loop or noise cancelling Headphones as a TV Listener.
Manufacturing software and maintenance target<€100 per unit, with a distributor price €150 and .05% (5 in every thousand) target penetration in three years of hearing aid market alone would result in €6,875,000 total turnover. With EPITDA of €2,291,666, a penetration of the non-hearing aid user market target of .05% (5 in every ten thousand) = €3,375,000 if sold indirect through distribution or €6,750,000 if sold via ecommerce. With EBITDA €1,145,83 indirect or €4,455,000 direct ecommerce and total units sold in three years 68,750
Socio-Economic and Societal Implications
There is no doubt that noise causes or contributes to a number of severe health consequences. Noise exposure has also been known to induce tinnitus, vasoconstriction and other cardiovascular impacts. Beyond these effects, elevated noise levels can create stress, increase workplace accident rates, and stimulate aggression and other anti-social behaviours. Improved protection through PiezoSelEx potentially has a strong beneficial impact on peoples’ health
List of Websites:
THE PROJECT WEB PORTAL
The website is available to the Project Consortium and the Home Page is also available to the General Public. Visit PIEZOSELEX at http://www.piezoselex.eu/
Contact Details:
Andrew Birkbeck
GBA Services Ltd.
Tel: +447809522004
Fax: +441772 816600
E-mail: andrew.birbeck@gbaservices.co.uk