Development of a Demonstration Tool for Bone Anchored Hearing Aids Master of Science Thesis in the Master Degree Programme Industrial Design Engineering, MPDES ELLEN HULTMAN SAMANTHA LÜTKEMAN PUKALA Department of Product and Production development Division of Design & Human Factors CHALMERS UNIVERSITY OF TECHNOLOGY Gothenburg, Sweden, 2013 Development of a Demonstration Tool for Bone Anchored Hearing Aids ELLEN HULTMAN & SAMANTHA LÜTKEMAN PUKALA Published and distributed by: Chalmers University of Technology Department of Product and Production Development SE-412 96 Gothenburg Sweden Telephone: +46 (0)31-772 1000 ACKNOWLEDGEMENTS Carrying out this master thesis project and developing the final concept demonstration tool have involved meeting several persons and receiving their input. The master thesis group is very thankful for their time and engagement, as this thesis could never have been taken this far without them. We would like to thank the team at Cochlear for initiating this project. Primarely Pernilla Pettersson for supervising us throughout this time and giving great guidance and engagement. We are also grateful to Göran Björn, Henrik Fryklund, Fredrik Breitholtz and Rom Mendel for their time and input during the evolvement of the demonstration tool. From the healthcare sector we give our greatest appreciation to Ann-Charlotte Persson for the hospitality and for always taking time to let us learn and attend at the Hearing and Deafness department at Sahlgrenska hospital. We also want to thank Maria Rosengren, Lisa Sundström and Annika Eliasson at Hörselcentralen, Sunderbyns hospital, Luleå, for sharing their experiences and thoughts around the Baha consultations and working as audiologists. Acknowledgements should also be made to Galantplast, Gothenburg and Kvarnby Textil, Mölndal for supporting us with materials during model making. From Chalmers we want to thank our supervisor Sara Renström and our examiner Ralf Rosenberg for supervising and supporting us during these 20 weeks and never hesitating to help us analyze our problems and challenges. Ellen Hultman & Samantha Lütkeman Pukala Gothenburg, 2013 ABSTRACT The master thesis project “Development of a Demonstration Tool for Bone Anchored Hearing Aids”, by Ellen Hultman and Samantha Lütkeman Pukala, was carried out at the department of Product and Production Development at Chalmers University of Technology. The project has been performed in collaboration with Cochlear BAS situated in Mölnlycke, Sweden. Bone conducted hearing is an alternative when single sided deafness, conducted hearing loss or a mixture of the two occurs. The bone anchored hearing aid provided by Cochlear, called Baha, consists of three parts and require a surgical procedure to be implemented. The project to come up with a new design of a demonstration tool was initiated as Cochlear defined a number of barriers to why patients refrain from the aid even though perceiving improved hearing. In addition new solutions to the Baha system will soon enter the market, which is why the company requested a new way to promote the Baha system options. The final concept is a handheld product facilitating the conversation between the audiologist and patient. By interaction opportunities the tool promotes the patient to take a more active role during the counseling situation, aiming to create an understanding and build a relationship to the product. To overcome preconceptions the demonstration tool clearly and simply presents the different parts of the Baha system in relationship to placement by an ear. A soft asymmetric grip creates attention and subtle colors and shapes support the presentation of hearing aid. Research for the design was done through interviewing audiologists working with the Baha system and observing patients during Baha consultations. Analyzing company core values, communication strategy and competitors in addition resulted in a context analysis. The analysis set the foundation for an idea generation to meet all needs and move design focus from being technology driven to softer values. Several concept evaluations together with Cochlear representatives resulted in a final result where materials, manufacturing, use experience, and visual appearance have been accounted for. Keywords: Industrial Design Engineering, Product Development, Demonstration Tool, Bone Anchored, Bone Conducted, Hearing Aids, Baha, Audiologist, Cochlear CONTENT 1. Introduction 1 1.1. Bone Conducted Hearing 1 1.2. Commissioning Company 1 1.3. Purpose 2 1.4. Goal 2 1.5. Constraints 2 1.6. Project and Report Outline 3 2. Background 4 2.1. Baha – Product and Function 4 2.2. Reasons for Baha 6 2.3. How to get a Baha 6 2.4. Living with Hearing Loss and Hearing Aids 8 2.5. Design Theory – Experience and Healthcare 8 2.6. Materials 9 2.7. Manufacturing 10 3. Methods – What and Why 12 3.1. Method Categorization 12 3.2. Planning 12 3.3. Data Collection 13 3.4. Analysis Tools 14 3.5. Creativity Methods 15 3.6. Visualization Methods 16 3.7. Evaluation Methods 17 4. Research and Analysis 18 4.1. Collection of Data 18 4.2. Context Description 21 4.3. Analysis Conclusions 26 5. Concept Development 35 5.1. Ideation Execution 35 5.2. First Generation Concepts 39 5.3. Second Generation Concept 43 6. Further Development 46 6.1. Further Development Process 46 6.2. Refinement Results 49 7. Final Results 52 7.1. Concept Idea 52 7.2. Counseling 54 7.3. Construction 57 7.4. Verification 60 7.5. Context, Color and Shape 63 7.6. Life Cycle Estimation 64 8. Discussion 65 8.1. Sustainability 65 8.2. Final Result 67 8.3. Sub-Result 68 8.4. Method Execution 69 8.5. Overall Project 70 8.6. Recommendations 71 9. Conclusion 72 References 73 I 1 1. Introduction Ground for this Master Thesis project is given in this chapter by history of bone conducted hearing as well as information about the company collaborated with. Furthermore, a detailed project scope description is accounted for. 1.1. Bone Conducted Hearing This project regards developing a tool to demonstrate bone anchored hearing aids, known as Baha. The tool aims to create an understanding of bone conducted hearing and promote bone anchored solutions as an equal option to conventional hearing aids. Hearing through bone conduction could seem like a new technology but has been known for long, since Antiquity. During the years 1700 and 1800 scientists and musicians experimented with bone and teeth conducted hearing aids in the form biting onto rods or strings attached to the sound source. During the 1950’s the development of bone conduction was applied to eyeglasses, yet the use declined and further development was needed. The first bone anchored hearing solution, with a fitted implant, was done in 1977 at the Sahlgrenska University Hospital by Swedish doctors who had developed the technology and products ultimately becoming the Baha hearing system (Kompis, 2011). Since then the Baha system has been refined through the years. It is not a relatively common solution compared to conventional hearing aids like behind the ear aids (BTE) or in the ear aids (ITE) (hrf, 2013). A bit negligently the bone-anchored hearing aid has been seen as a bit of a last solution when BTE or ITE aids have not been enough (Pettersson, 2012). 1.2. Commissioning Company Cochlear Limited, which was established in 1983, has their head quarters in Sydney Australia. The company has three product categories regarding hearing aid, the cochlea implant hearing system Nucleus, the bone anchored hearing system Baha and the electro acoustic hearing system Hybrid. Cochlear has had Baha in their product range since 2005. (Acquisition, 2005) Cochlear was for long the major supplier of the Baha solution, which is also the registered trademark of the their product. In recent years a few other companies have entered the market with equivalent solutions. In addition to the competition for customers the target group is also seen as possible to broaden. Baha does not have to be a last alternative but instead an equally functional solution which could improve hearing to many more than who are subjected to the solution today (Pettersson, 2012). In order to tackle the competition and gain customers choosing Baha, Cochlear has set up a communication strategy. Focus is to be shifted from facts and technology orientation to instead put softer values and the emotional engagement first. By tools communicating company core values Cochlear wants to enhance the user experience, increase the conversion of people choosing Baha and create a long lasting customer relationship. Today the sound of using a Baha hearing system can be experienced prior to surgery, yet from a potential candidate perspective little information about life with Development of a Demonstration Tool for Bone Anchored Hearing Aids the Baha as a product and the surgery is given. The existing demonstration tool, see image 1, informative texts, illustrations and pictures do not reach all the way so a new demonstration tool to fill the gap is desired. 1.3. Purpose The purpose of the Master Thesis project is to design a new physical demonstration tool to be used during the audiologist counseling. Research questions: • How could a new demonstration tool communicate an understanding of the surgery and daily care with the Baha system? • How could a new demonstration tool facilitate an attractive presentation of the products through; display of the Baha system, explanation of features and benefits, functional use by snap- training and communication of the company core values? 1.4. Goal The goal is to, as result of the thesis project, have developed a concept possible to implement in the near future. This concept should consider aspects like price, (material, production volume, manufacturing methods etc.), usability and cognitive ergonomics. The longterm perspective of this project is to establish Cochlear’s position as leading in providing reliable products and optimized solutions that will last and function well with future innovations. 1.5. Constraints The project does not focus on the detailed aspects of the Baha itself in terms of technology or design. The market for the demonstration tool is global yet restrictions will apply on how much the project can be validated in other countries’ contexts than Sweden’s. The project will be brought as close to manufacturing as possible. Yet academic aspects will be prioritized and preparatory work for manufacturing such as collecting ultimate quotes cannot be obtained within the master thesis scope. Although the target group of people with hearing loss is diverse, this project is directed towards adults as the parents make the decisions for their children. Image 1. The demonstration tool of today I 3 1.6. Project and Report Outline Two students hereafter referred to as the master thesis group conducted this project. The project contains six main phases, image 2, that have been conducted using an iterative process. This means that even though they are described separately in this report they have been processed and developed several times as the project proceeded. For a more detailed process flow chart see appendix 1. Throughout the phases input and guidance have been given from mainly two stakeholders. Pernilla Petterson, who is a senior product manager of Implant and Surgery at Cochlear Bone Anchored Solutions, initiated the project and has been the primary support. Along the evolvement of the project she has involved employees with relevant expertise to support development and make decisions. Ann-Charlotte Persson, authorized audiologist at Sahlgrenska hospital in Gothenburg, has been providing information and support of the patients and the healthcare context. Regular contact and meetings have been held with both stakeholders and the proceedings of the project have been done in consensus. Each chapter in the report start with an introduction of what the chapter will discuss. An execution will follow and then the chapter will finish with the main results and outcomes of the particular phase. This means that sub deliverables of the phase might be mentioned in the execution as they lead forward to the main result. Thus the reader can move straight to the result for quick review of the phase outcome or go through the execution for a deeper insight. For less experienced readers within the subject, methods and theory is a good start, while more experienced readers might find the research phase a more interesting beginning. Image 2. Project Outline 2. Background The background chapter covers several areas, ranging from the Baha system and hearing loss to Cochlear’s market position and strategy as well as design experience and manufacturing. An understanding of these areas are needed to set a foundation for this thesis as they all play a part in the demonstration tool being designed. The Baha system needs to be understood in order to know what is important to communicate with the tool and finding out more about hearing loss will direct who the tool is for. Understanding Cochlear’s market strategy and the creation of an experience through design will give input on how to communicate in order to reach the best outcome. 2.1. Baha – Product and Function The Baha hearing aid consists of an implant, an abutment and a sound processor. The titanium implant is ossiointegrated (Brånemark, 2010) in the skull bone, meaning the bone cells are attached directly to the implant. The titanium abutment is connected with the implant and will be surrounded by tissue as it comes out of the skin layer to connect to the sound processor, image 3 and 4. The sound processor has an exterior of the biocompatible plastic PEEK. Image 4. Baha System (Baha system, 2013) Image 3. Baha integration (Baha integration, 2013) I 5 In usual hearing, see image 5, vibrations in the air travel through the outer ear putting the eardrum in movement. This forwards the vibrations via the small bones in the middle ear to finally be received by the cochlea, also known as the inner ear. If the outer and/or middle ear are somehow damaged a Baha system transmits the airborne vibrations through the sound processor and onto the abutment and the implant, see image image 6. The implant makes a vibrating connection via the skull bone directly to the Cochlea, and thereby hearing is created (University of Maryland, 2012, Audio bone 2008). The Baha sound processors, image 7, picks up frequencies up to 8000Hz where normal speech is within 1000 to 3000 Hz. There are three different strengths of sound processors that make up for 45, 55 and 65 db hearing reduction, see appendix 2. To facilitate for different environments the user might be in, the sound processor has three different programs to alter between. These programs can be individually set to fit the specific user. Yet there is a standard program making automatic switches to suit the most commonly used environment (Persson, 2012). The programs used to be set by an analog interface, but new processors have digital software. To further suit the individual the sound processor comes in different colors to either blend in with e.g. the recipients hair color, or to stand out in brighter colors. Also different accessories, see appendix 2, will facilitate certain activities and environments like an audio streamer for television, FM receiver for noisy environments, telecoil for public buildings supplied with loop and for talking on the phone and a safety line. These accessories vary for the different processors. Samples of these accessories are shown in image 8. Image 5. Normal sound transmition Image 6. Transmition with the Baha system Image 7. Baha sound processors lined up by increasing strenght (Baha Sound processors, 2013) Hammer Anvil Stirrup Semicurcular Canals Cochlea Auditory Nerve Eardrum Auditory canal Temporal bone Outer ear Middle ear Inner ear Development of a Demonstration Tool for Bone Anchored Hearing Aids 2.2. Reasons for Baha Bone conducted hearing through the Baha system can be a solution for in general three different types of hearing loss; conductive hearing loss, single sided deafness and a mixture of the previous two (Pettersson, 2012). Basically one cochlea or inner ear needs to be intact, meaning there has to be a sensorineural function in order for Baha to work as a hearing aid. Conductive hearing loss can have many different causes. The issue is that the sound vibrations cannot travel as normal in the outer and middle ear to reach the cochlea of the inner ear. Deformity of the ear canal, otosclerosis and chronic otitis among other issues can be reasons for conductive hearing loss (Dillon, 2007) . The Baha system is placed behind the impaired ear to improve the perceived hearing. Single sided deafness, sensorineural hearing loss, means that one ear has significantly or totally reduced hearing. The impairment regards the inner ear meaning that the cochlea is damaged. To solve this sort of hearing loss the Baha system is placed behind the impaired ear and sound vibrations reaching the malfunctioning ear are via the skull bone redirected to the better ear (SSD, 2013). Mixed hearing loss is where both conductive hearing loss and single sided deafness occurs (Pettersson, 2012). When both ears are affected a Baha for each ear is a solution. It is estimated that 5000-6000 people in Sweden have bone anchored hearing aids at the present time (Persson, 2012). 2.3. How to get a Baha The healthcare systems way of providing hearing aids have within this project only been studied in Sweden due to time and economical limitations, although the Baha solution is provided in several other countries around the world. Companies providing hearing aids do offer self- counseling information most commonly via their homepages. Self counseling is an estimative first step to use by the individual to see what type of hearing loss the person might have and what hearing aid would Image 8. Samples of Baha accessories and color options (Baha accessories, 2013) I 7 be suitable. Yet to get a hold of the aid, contact with a healthcare professional is needed. Within Sweden and the different county councils there is no common structure of how to provide patients with hearing aids. Since the use of Baha is very low, the process of how to get this particular aid is even less structured. Counseling Due to the development of the technology behind Baha occurring in Gothenburg, the healthcare sector of Västra Götaland has been leading in the handling and knowledge of the Baha solution. Recently healthcare professionals in Gothenburg working with different aspects of the Baha solution have developed a care program of how patients will receive a Baha, ranging from initial counseling to activation of the sound processor (Cochlear Workshop 2012, Eeg-Olofsson ). Hearing diagnostics and rehabilitation are done in following steps according to the program. 1. Examining hearing diagnostics with standardized tone and speech audiometry. 2. Referral briefing in Bone Conduction Team (BCT). Decision if patient is appropriate for bone anchored hearing aid. 3. Evaluative appointment at audiologist prior to hearing rehabilitation. 4. Hearing rehabilitation is planned individually based on patient needs, prerequisites and wish for interventions. Patient is informed about existing bone anchored hearing aids. Patient gets to try bone-anchored hearing aid on softband/ headband during a minimum of four weeks. 5. Revisit and evaluation of bone anchored hearing aid on softband/headband at audiologist. 6. When outcome is positive, doctor’s appointment for surgery and medical evaluation. Patient is there informed about the operation and the side effect that can arise from it. Surgery Moving forward with a bone anchored hearing aid will involve surgery. The operation takes about 40 minutes and the patient can usually return home the same day. The surgery is generally performed in the following steps (Surgery Baha, 2013, Cochlear Counseling Software, 2008). 1. The hair is shaved around the area. The insertion point for the implant is marked out approximately 50-55 mm from the ear canal, on a relatively flat bone area in line with the upper part of the pinna. Commonly used hats or helmets can be brought to make sure there is no interference with the Baha system location. Yet if the implant is placed too far up it will be farther from the cochlea and the amplification will not be as good. If the implant is placed too far down the bone will be more porous, which will make the implant less stabile. 2. The patient is locally anaesthetized down to the periosteum layer and the pinna is bent over the ear canal to make room for the operation area. The surgery can now continue in two different ways either using: The linear incision Technique 3. A linear incision is made trough the soft tissue and periosteum. The implant hole is drilled 3-4 mm into the skull bone. The implant is placed. 4. Approx. 40x60 mm of soft tissue is removed and skin is sewn together. This leaves the patient with an as small scar tissue as possible Or The Baha Dermatome Technique 3. A dermatome, a razorblade like tool, is used to create a 40x60 mm skin flap. The implant hole is drilled 3-4 mm into the skull bone. The implant is placed. 4. Approx. 40x60 mm of soft tissue is removed and skin is sewn together. The technique is easier to use yet takes longer to heal and leaves a bigger scar. The surgery can also be done in one or two stages. For patients with good bone quality and thickness the FAST method is recommended. This procedure involves soft tissue reduction and insertion of an implant with a premounted abutment. For people with soft, compromised or bone less than 3mm in thickness the first stage is performed as mentioned above for an implant and cover screw. Later at a second stage the abutment is fastened on to the implant. Care and Complications After the surgery the abutment is left with a dressing and healing cap until the stiches are removed. After 5-6 days the audiologist will check the healing process and after 5-6 weeks the fitting of the sound processor can take place. Adjustments and sound processor programs will then be set for the individual. Development of a Demonstration Tool for Bone Anchored Hearing Aids Living with Baha demands aftercare. The abutment is mainly cleaned with toothbrush-like brush e.g. during a shower. An after care kit is ususally provided by the company behind the bone anchored hearing aid (Procedure Baha, 2013). The surgery is relatively harmless yet as with all medical interventions here can be complications (Breitholtz, 2009). • Numbness can occur round the abutment area where soft tissue has been removed. • Infection around the abutment and soft tissue area can arise during the healing process and in the event of lacking after care. • Skin overgrowing the abutment. (Can be helped with a longer abutment). • Flap necrosis can occur for the skin flap when healing with no underlying soft tissue. • If the implant fails to osseointegrate it can fall out of the skull bone. 2.4. Living with Hearing Loss and Hearing Aids Hearing, as one of the five senses, plays a great role in the perceptions of a context and the personal experience. Orientation when sight is reduced, communication with other people and reflex reactions as a response to warning signals are all made through hearing. Realizing the sense of hearing is being reduced can be an overwhelming experience. Usually linguistic sounds are lost and the nuances in conversations disappear. Also listening to a group conversation is difficult and much more attention is required which is tiring. Telephone and doorbell signals are missed out on as well as sounds or name calling from afar. The healthcare sector in the county council of Västra Götaland working with hearing loss has compiled several advices on communication strategies for persons with hearing loss. The advices also includes strategies for relatives and friends (Leaflet, Hörsel- och Dövverksamheten). Considering position in a room, having the better ear towards the sound source, speaking towards the person with hearing loss and not covering the mouth so lips can be read are just a few advice given. To ease hearing loss there are many different hearing aids. Many individual factors play a part in what specific aid it is that will suit each and every person. A hearing aid can never replace a normally functioning ear, but it can come very close to a natural sound experience if it is used the right way. Deaf communities and hearing loss associations exist all over the world. Living with hearing loss can involve a lot of challenges so the exchange of information and experience is of great value, both from healthcare professionals and between individuals. In Sweden HRF, Hörselskadades Riksförbund, is a large national association that has sub groups e.g. towards children, relatives and regional offices. Communities and associations function as a gathering point and can create a sense of belonging to those who identify themselves with it. In helping people and introducing hearing aids to them there also has to be humbleness, showing that the interventions towards hearing loss are made on the premises of the individual. Only if and to the extent the personal engagement stretches, aids should be provided. (UR dövidentitet och hörande, 2007, UR dövkultur och identitet, 2007) Many factors have to match during the consultation of hearing aids and hearing loss. The audiologist has a theoretical knowledge that has to be applied in a personal way to meet the patient. Facts and results have to be presented in a clear way and the patient has to be willing and ready to take in the information. If the diagnostics of hearing loss becomes too emotional to handle the patient is most likely not able to handle problem solving at the moment and a softer approach to the consultation is needed. (Clark, 2010, Gailey ) 2.5. Design Theory – Experience and Healthcare Design has generally been connected to function and aesthetics. Function in a more mechanical meaning where the design should e.g. provide a specific use or optimization. The functions and the aesthetics are strong factors playing a role in users perception of the product and the desire to use it. Together a user experience of the product is created. The experience perspective especially comes into play when products are not directly aimed towards a purchasing consumer but when the product is mainly handled or involved in a certain context or situation, e.g. receiving oxygen at hospital involves the experience of an oxygen mask, which is the central product. The uprise of services, involving products, replaces contact with just the actual product. Services are strongly I 9 connected to experience, e.g. getting service at a car mechanic, where the consumer pays for the service of getting the car repaired as to buying tools and fixing it by oneself. An experience involves the perception and although the perception of an object can be very clear the experience can be less obvious (Schifferstein, 2008). The state of mind or the mood the perceiver is in as well as what context the object is placed in will matter for the experience and interaction. In the design of a product there is a relationship between the concrete, e.g. that the object has a sharp angle, which can be perceived by sight or touch, and the symbolic, that it is experienced as e.g. aggressive. To achieve a stronger experience one theory is that people prefer an optimal level of arousal when it comes to perceiving the symbolic in an object. Asymmetric shapes are said to give greater arousal as the object becomes more expressive and dynamic (Ibid.) In the experience of an object, metaphors are a way to reduce the cognitive workload by making users relate to something they already know. Relating to a product and associating it with something can, when it is in a positive matter, enhance the experience of emotional attachment. This will be fruitful for a company over time, as it will make customers loyal wanting to stick with e.g. the brand. Product attachment can be determined by four factors (Ibid): • Pleasure – provided to the user by the product. Here surprise can enhance the pleasure by the physiological effect of e.g. increased heart rate that makes the user focus more on the object. A surprise effect also tends to more likely be stored in the memory. • Self-expression – connects and shows ones personality and differentiates the individual from others. Product and meaning need to be intertwined to be less likely to replace. • Group affiliation – the product make the user a part of a group, which it identifies itself with or wants to be identified with. • Memories – the product brings out positive memories, effective ways to this can be by odors and making the object age gracefully. Yet to predict the meaning of a product in advance is hard and is also highly dependent on the individual. 2.5.1. Design Experience in a Healthcare Context Experience is well connected to the context and environment. In a healthcare context extra attention should be given to supportive design, helping the user to cope with the situation as they are usually dealing with a condition to improve (Koblanck, 2004). Design for everyone (Bohgard, 2009) is also an important aspect as patients, especially of hearing loss, is a very diverse group. The design needs to be considerate towards the difference in mental and physical conditions, cultural backgrounds and so on. The healthcare sector includes many areas, towards the patient these could primarily be quality, security and service in the care provided. All of this makes up one experience for the patient. Feeling seen and listened to and understanding the treatment and care about to be given are important aspects in the communication between the patient and professionals. E.g. time limitations and terminology can shift focus from professionals to patients point of view (Wolf, 2013). 2.6. Materials This section will account for materials suitable for the demonstration tool to be designed. 2.6.1. EVA (Ethylene-Vinyl-Acetate) EVA is an elastomer build around PE, see chapter 2.6.2. It has properties like being soft, flexible and tough, which are kept even in lower temperatures. EVA has good chemical resistance and can be processed by usual thermoplastic processes e.g.: blow molding, rotational molding, extrusion, injection molding and transfer molding. EVA is applied e.g. as dispensers, cable insulation and in running shoes (Ashby, 2010). 2.6.2. PE (Polyethylene) PE is very resistant to food and most water-based solution, thereby it is commonly used for household products (Ashby, 2010). It is a cheap material, easy to mold and can be produced in the form of rods, films, sheets, foams and fibers. PE can come in various colors or be transparent, translucent or opaque. It has a bit of a waxy feel to the surface of it, the surface can be textured or coated but is difficult to print on. PE can be made from renewable sources and is classified as highly recyclable. The longer and less Development of a Demonstration Tool for Bone Anchored Hearing Aids branched the molecule chains of PE are, the stiffer and stronger the material gets (HDPE). Exposing the surface of PE (LLPE in particular) to fluorine gas makes the surface a fluoro-polymer, know as “Super PE”, which is resistant to organic solvents like petrol, cleaning fluids and cosmetics. Very low density PE (VLDPE) is similar to EVA. 2.6.3. PLA (Polyactide) PLA is made from corn maize or milk and is a biodegradable thermoplastic. It is glossy and clear but stiff and brittle. It can be processed into fiber or films, be thermoformed, extruded or injection molded. Being a biopolymer PLA is expensive costing about twice as much as PP. PLA is commonly used for food packaging, cups, plastic bags etc. Since it is made out of renewable sources it can be recycled but one good appropriate option is industrial composting at end of life (Ashby, 2010). 2.6.4. PMMA (Ploymethylmathecrylate) PMMA or Acrylic is also known under the trading name Plexiglass. It is stiff and hard as a polymer, and similar to glass transparent and fragile. PMMA comes as sheets, rods or tubes by casting or extrusion. PMMA’s transparency can be colored, the surface scratches more easily than glass, but coatings can help that. PMMA is used for all type of lenses, windows, CDs etc. Acrylics are non toxic and recyclable and not very resistant to solvents, acetone and strong acids and bases (Ashby, 2010). 2.6.5. PP (Polyproylene) PP is very similar to PE in aspects regarding price, process methods and areas of use. PP properties are similar to HDPE yet is stiffer, more rigid and tolerates higher temperatures. PP is water resistant and comes in various colors. When drawn into fibers PP has a great strength and resilience exceeding the ones of PE, this is why ropes and fabric are popular applications. Like PE, PP is recyclable and is made by processes relatively energy efficient (Ashby, 2010). 2.6.6. Polymer Foams Foams are cellular materials originating from solid polymers. Foams can range from soft and flexible to hard and stiff by expansion and solidification or by melting through an either physical, chemical or mechanical blowing agent. Polymer foams will cushion and insulate energy, e.g. expanded EVA and PVC with small cell sizes and an intact surface is used to absorb shock and vibration for running shoes. The polymer foam can be created in place, by injection molding, extrusion, thermo-formed, laminated or casted (Ashby, 2010). 2.6.7. SBS (Styrene-Butadiene Elastomers) SBS is a synthetic rubber with hard and soft segments. The styrene provides the thermoplastic properties and the butadiene the rubber properties (TPS, 2010). The elastomer is low in strength, which usually demands reinforcement. SBS has a low cost but a low recycle potential as well (Ashby, 2010). 2.6.8. TPE (Thermoplastic Elastomers) TPE has the properties of vulcanized rubber yet can be processed as thermoplastics by being molded or extruded (Ashby, 2010). There are variations of TPE. TPE is highly recyclable and can be reused during process. TPE can range from gel-like to stiff (TPE, 2010). 2.7. Manufacturing This section will account for manufacturing methods suitable for the demonstration tool to be designed. 2.7.1. Laser Cutting Laser cutting is done by the material being vaporized due to the high-energy intensity. Usually continuous carbon dioxide lasers are used, except for small details where Nd-YAG lasers are more sufficient. The lasers output effect, focus, added gas and the absorption ability of the material make up the function of the process effect. Plastic thickness up to 50 mm can be processed and caution has to be taken regarding possible toxic gases being emitted (Hågeryd, 2002). 2.7.2. Milling A milling cutter is appropriate for processing of flat materials and small to medium sized pieces. As with all types of cutting machining a milling cutter processes a material by chip removal. The tools and types of milling cutters can have large variations. The tool can I 11 have a vertical or horizontal placement, and in addition to its rotating movement it also needs to move in a vertical or horizontal direction. The material of the tool needs to be hard and strong at high temperatures, though to not chip itself against the processes material and wear resistant (Hågeryd, 2002). 2.7.3. Expanded Foam Molding Expanded foam molding creates a three-dimensional solid shapes and the foam material at once. Beads of the desired material are placed in a mold. Being exposed to heating and pressure these beads expand by a foaming agent. The shape will get a smooth closed surface when in contact with the mold. Thermoplastics are easy to mold like this and the method is cheap, which is why many single-use articles and disposable products are manufactured this way (Ashby, 2010). Development of a Demonstration Tool for Bone Anchored Hearing Aids 3. Methods – What and Why Several methods have been used in this master thesis project to get a thorough development and to have helping tools for the different project stages. Methods can be categorized after their properties and thereby be matched to suit the purpose of the data collected (Bohgard, 2010). 3.1. Method Categorization The origin of the data makes a method analytical or empirical. An empirical method studies the users of an actual system. In an analytical method no user is studied, instead people with specific knowledge make evaluations of the system. The type of data collected makes a method objective or subjective. Objective data is gained from measurements that are not dependent on a specific individual. Subjective data is collected from personal experiences. Methods can have both objective and subjective elements. The type of results makes a method quantitative or qualitative. Quantitative results are usually in figures from objective methods observing or measuring. Semi-quantitative results origin from rankings or categorizations on e.g. a scale. Qualitative results are more detailed and arise from questions like who, what, why, where, when and how. When using a qualitative methods caution must be taken on how influence is made on participants. The extent of user involvement makes a method participative or expert (Bohgard, 2010). In participative methods there is a high level of user involvement in implementing and controlling data collection and analysis. In an expert method only the implementer controls the data collection. Most commonly the user acts as an information source and the implementer controls the implementation (ibid.). 3.2. Planning Planning was done during the project initiation and followed up throughout the process. 3.2.1. Gantt Chart A Gantt chart is a tool to represent time committed to certain tasks. A horizontal timeline is made for the entire project scope. Tasks are listed vertically and horizontal blocks mark their time consumption and when during the project they are to be done. The chart also shows which tasks can be performed in parallel (Ulrich, 1995). Structuring this project as a whole and tasks to be performed was important to optimize time and resources used. The Gantt chart was a good way to overview and visualize time and planning aspects. 3.2.2. Backwards Planning Backwards planning means starting from the desired result or project goal, setting out the starting point and then structure the space in between. As the goal of a new demonstration tool was pre- identified, backwards planning was a good way to set up the planning and schedule for the project, to keep to focus on the outcome and plan effectively according to that. I 13 3.2.3. Diary Notes Daily diary notes were kept during the entire thesis project to document accomplishments, activities, decisions and thoughts in writing. Daily diary was chosen in order to see progress and also as the continuous documentation. 3.2.4. Process Flow Chart A process flow chart describes a project process from start to end by symbols and links. The symbols and links mark out the elements of the process and what is included in the different stages of the process. The flow chart gives an overview easy to communicate, creates an understanding, documents and describes how the project should be done (Mindtools, 2013). The symbols are to some extent standardized, see image 9, making the communication and understanding even more clear (Cinergix, 2013). 3.3. Data Collection Data collection methods have given necessary theoretical knowledge about various areas in the project. The methods were more intensely used in the beginning of the project. 3.3.1. Literature Studies A way to get background information or more insight in a subject is by literature studies (Bohgard, 2009). Articles, research studies, books and many other written documents can add knowledge. In addition to written documents similar information gathering can be done by watching documentaries and online seminars. Depending on the vastness of the literature study it can be defined differently. In this case the method has come to be subjective and qualitative considering the difficulty in disregarding the subjectivity of the authors and the relatively low amount of sources. The method was in the project used to get background information and an understanding for the area of the thesis. 3.3.2. Interviews Interviewing is primarily a subjective qualitative method where people state their experience, opinion, thoughts, values and so on. Interviews can be categorized into structured, unstructured or semi-structured (Bohgard, 2009). During this thesis project unstructured and semi- structured interviews were performed where open questions were asked and there were a possibility to direct the discussion towards what evolved as interesting during the interview. Unstructured interviews gave qualitative data, which is harder to compile but useful for explorative studies. The method was used as background information and setup was chosen to allow the experts to tell and acknowledge important parts that the project team was not initially aware of. 3.3.3. Observations To find out how people act in a given actual situation observations can be used to collect data. Behavior is noted which the users might not even be aware of themselves. On the other hand, the natural environment might not automatically provide natural acts if people know they are being studied (Bohgard, 2009). For this project direct unsystematic observations were done, meaning they occurred in a real environment with no specific aim, thereby being empirical and participative. They were also performed as an objective and qualitative method. Underlying reason for behaviors during observations was not gained, unless complemented with an interview. The observations were conducted to get initial knowledge and see actual behavior. Observations were also used as a comparison to verify theory with practice. 3.3.4. Benchmarking Benchmarking is a way of comparing primarily processes and not products specifically even though products might be improved by improving processes. Looking at other companies within the same segment A rounded rectangle symbolized a start or end of a process A rectangle defines an action or operation to be done. The parallelogram contains data to be collected as input or output of a process. A diamond states a decision to be made or question to be answered. Image 9. Standardized Process Flow Chart Symbols Development of a Demonstration Tool for Bone Anchored Hearing Aids is a way to see differences and trends on the market (Bohgard, 2009). The benchmarking was conducted mainly to see how other hearing aid companies promote their solutions and what message they are sending as well as to identify the current trends in the field. 3.4. Analysis Tools As a continuing phase to the theory studies, analysis methods have been used to evaluate the data collected. 3.4.1. SWOT SWOT stands for Strenghts, Weaknesses, Opportunities and Threats. The areas are usually divided into four blocks in a rectangle. SWOT is used to identify and easily list these areas for an organization and it separates and gets participants to start thinking of how the organization or system e.g. looks or functions. Strenghts and weaknesses are seen as internal factors to the organization while opportunities and threats are depending on external factors. (SWOT, 2013) SWOT was used as a quick way to state these factors for the company and the tool to be developed in relation to the market but also internally within the company. It breaks down what to enhance and what to improve. 3.4.2. Design the Box This is a method useful to start off a project and make the team get a common view of what the result will be when the project might not be fully tangible, e.g. implementing a new organization system (Spolsky, 2002). The idea is for the team to together shape and design a physical box to represent the core of the project, e.g. with color, size, texture, name, slogan and so on (McMullin, 2007). For this project the method was modified to instead explore expressions during a workshop. The box was to be redesigned to represent a certain expression. Design the box was used to get a more tangible starting point when exploring expression in design. The method was considered very useful as it created something physical to work around. 3.4.3. User Profile Studying users involved in the products or system, data can be compiled into user profiles stating specific characteristics and relationships amongst the user groups. User profiles should be made early in the project to set the foundation and reasons for development, redesign and evaluation (Bohgard, 2009). Users are usually divided in to four groups (Ibid); • Primary users are interacting with the product or system due to its actual purpose, e.g. user using a tool • Secondary users use the product but not for its primary purpose, e.g. selling or repairing the tool. • A side user is affected by the product but do not fit in the first two categories, e.g. a person being in the room next to where the tool is being used and thereby hearing or feeling the use of it. • Co-users work together with the primary or secondary user but is not interacting with the product directly, e.g. using another tool in the same construction work. Several persons can qualify as primary users for a product and one person can fit several user roles. A user profile is made up by six elements (Ibid); • Background: user type, age, language and place of residence and educational background. • Use: knowledge, mental model, experience, frequency of use. • Influence and responsibility: opportunity to choose product used, influence on the situation and responsibility for the product. • Emotional relationship: ownership, social aspects, products mental influence on the user. • Type of interaction: cognitive interaction, physical handling, opportunity to use the product with disabilities. • Activities, goals and motives: what the user do with the product, its goal and motivation behind the usage. User profiles was compiled as a good way to define the different people connected to the product being developed. Besides it structured and sorted out who the product really is being designed for. 3.4.4. Clustering Clustering is an effective way to structure large amounts of data to see common denominators and sort out relevant elements to be considered. Clustering helped in sorting out the content of articles I 15 in the literature study and it was used to find interest areas and structure the key aspects. 3.5. Creativity Methods Creative methods have been used mostly during the ideation phase to start the product development and bridge over from analysis to concept and further evaluation. 3.5.1. Issue Cards Issue cards are used as a way to freely draw or write insights, ideas or any other type of issue that comes to mind. They are used to trig interactivity amongst group members and are a simple way to work around something tangible than just having a verbal discussion (Tassi, 2009). Issue cards were used to start interactions with people new to the project that was only spoken to for a short while. The issue stated on the card was used as a way to trigger thoughts and discussion. 3.5.2. Assumption Bursting To define assumptions drawn about the situation the idea is to list and challenge them. Some things might be obvious or not even considered as possible to overcome or change. Listing assumptions and bursting them might loosen the limitations of the situation and give a new perspective on things (Assumption Bursting, 2010). The method starts with setting the situation, and then listing the assumptions about it. Then the assumption is challenged by a bursting and step by step this continues (Ibid.). Eg. Situation: we cannot sell our products over the Internet. • Assumption: we do not have the technology • Burst: we could buy it • Assumption: it is too expensive • Burst: we could learn or look if there is a good price to get the service for. • Assumption: learning will take too long and too much effort • Burst: we do not know until we try and it might generate more value in the long-term perspective. The assumption bursting was good to challenge the own prejudgments and assumptions to not unconsciously limit or block certain aspects. 3.5.3. Moodboards Boards can have many functions. It is a way to show what visual aspects are desired. It can be as a more detailed specification of elements to include or more loose as a source of inspiration and creativity. Moodboards connect to the main impression and atmosphere that one wants to achieve.Various things can be included in a board, e.g. details, surface materials, textures, colors, shapes, graphics and so on (Österlin, 2010). The method was selected mainly as moodboards were a good communication tool when working with others, e.g. in a workshop or within the thesis group. 3.5.4. Personas A more fictive variant of a user profile is a persona. A persona is a fictive person corresponding to the needs and requirements of the product, simply defining the person the product is being designed for. Collected data set the basis for the persona and several personas can be created to match the entire target group, which might not be homogenous. A good strategy is to focus on one persona at the time. The description of a persona should be complemented with a picture or illustration to get a visual description as well (Österlin, 2010). Personas were used as it was a good way to combine all information sources and user aspects into a fictive person to discuss around. The personas were also used as a creative tool. 3.5.5. Storytelling and Scenarios A way to connect the persona to the product is by storytelling. Storytelling brings out the personas experiences with the product throughout its lifecycle, it could be from watching a commercial to buying and using the product until it is discarded. The scenario should bring out the products effect on the persona, how is it experienced, what emotions does it arouse, in what situations is it used, what alternatives might be on the market and so on (Österlin, 2010). The methods were used to put the product and its user in a context and situation, which is fruitful to tangibly see how, when and where the concept can be used and what purposes it actually serves. Development of a Demonstration Tool for Bone Anchored Hearing Aids 3.5.6. Design by Analogy Using analogies in design is taking inspiration from other things, situations, systems etc. to move forward in development processes. Inspiration from nature is a common example, e.g. looking at different types of wings when creating a sail. Other already existing products can be sources of inspiration also regarding material properties, expressions and so on (Linsey, 2007). The analogy was a good way to make attributes or expressions more tangible and communicative for a specific product. 3.5.7. DFA Companies providing a range of products need to have consistent design elements in order to create a strong identity within the product families. Connecting them to the company is important for customers’ recognition and for enhancing the company brand identity. Also when developing new products it is important to consider existing design elements and product design history (Warrell, 2001 ). Design Format Analysis, DFA, compares products to identified design elements and ranks them in order of consistency. The products to be analyzed are placed on one axis and the defined design formats on the other. The intersection of product and design format is then market for a filled circle for a strong correlation between product and element and a circle for a weaker correlation. The summed score will then tell which products have a strong identity and which formats best represent the company design (Ibid.). DFA was done to identify the Baha design elements to make the coming demonstration tool fit well with the Baha system. 3.6. Visualization Methods Visualization methods have helped to illustrate and develop concepts as well as to set a foundation and to build material for discussions with stakeholders. 3.6.1. Sketching Sketching is a method to be used in several different levels of detail. Quick small sketches can be done in thumbnail size and these can be evolved to more detailed concept sketches in larger formats. By sketching, ideas can be illustrated and described visually in a way that words may not fully do (Österlin, 2010). In the development process of a physical product sketching functions well to combine with other methods. It is also a great way to discuss around ideas. 3.6.2. Sketch Modeling Making a sketch model is a quick way of sketching in three dimensions. Besides it is a useful way to try functions, shapes, structure, etc. The sketch model can be made full scale as a mock up to be tried in the thought of environment or in scaled versions (Österlin, 2010). As the end result was to be a physical product, sketch modeling was a great method during the development process. Both in order to try grip dimensions and construction in early stages and realizing things simple to improve early in the process. 3.6.3. CAD Using CAD-tools (Computer Aided Design) is a helpful way to visualize a product before making a physical model. CAD-tools also facilitate easily made drawings, three-dimensional views, calculations and movements of mechanical systems among other things (Johannesson, 2004). In this thesis project Autodesk Inventor Professional has been used to make the final product as realistic as possible, both in terms of construction and visualization. 3.6.4. Rapid Prototyping Rapid prototyping is a quick way to turn CAD-models into physical objects. By 3D-printing geometries no machining is needed which makes the process fast when trying out designs (Johannesson, 2004). In this project the 3D-printing was done by layering that melts together in to the desired shape. Rapid prototype was used to quickly try out the interaction with the demonstration tool and to evaluate the physical and emotional aspects of the handling. 3.6.5. Function Modeling A function model aims to test possible operations and tasks to be performed with the product. It is also a good way to verify construction and assembly. Focus is not put on visual aspects instead the functionality is I 17 explored (Österlin, 2010). The thesis group used function models to try out appropriate materials and assembly. The function model also showed how well the final product would suit the intended context and worked as a communication tool for explaining the project result. 3.7. Evaluation Methods Evaluation methods have thoroughly been used to review content and served as a framework for the decisions made. 3.7.1. Morphological Matrix Morphology is the study of shape structure and shape development. Having many factors and combining these will generate a large amount of variations. These variations can be sorted in a matrix to evaluate combinations (Österlin, 2010). A morphological matrix was a good way to sort out which factors are met through each solution. 3.7.2. Pugh Matrix Concept evaluation can be done with a Pugh matrix as it reduces the numbers of concepts in a quick and easy way and the selected concepts can be improved and refined. The concepts are listed on one axis and the criteria of the evaluation on the other. Besides a reference concept is listed which all other concepts are evaluated against (Ulrich, 1995). The concepts are ranked as better (+) than the reference concept, the same as (0) or worse (-). This rather simple manner is done to get a hint of the ultimate solution. The scoring is summed and controlled to see that all concept features have been evaluated in a sensible way against the criterions. The concepts to take forward are finally selected based on score (ibid.). A Pugh matrix was used as it was an effective way to include the current solution in the evaluation and make sure that the most valuable concepts are the ones brought forward. It is also a good method to go through concept features. 3.7.3. The Customer Journey Canvas Marc Stickdorn and Jakob Schneider have developed the Customer Journey Canvas, which aims to give support when designing services. The tool maps not only the studied service, but also the pre-service and post-service stages. The tool should be used as a template, which could be modified to suit specific uses. The reasons for using the canvas could vary from mapping the overview picture of service processes to the exploration and evaluation of services, taking the customers’ or other stakeholders’ perspectives (CJC forum). The tool was useful for mapping the insights from the analysis and supports in keeping the perspective of the candidate throughout the counseling experience. Besides it provided a summary and overview to the readers of the report. 3.7.4. User Tests User tests are subjective and have been done in both participative and expert ways. In user tests people get to try out a system or product and give their opinion that is noted and considered e.g. under the further development phase. User tests, in particular of sketch models, were done to establish the further development of the demonstration tool and to evaluate the product from a patient and professional user perspective. 4. Research and Analysis As described in chapter 2.3, the process of getting a Baha is a non-standardized process employed by numerous clinics with different organizational structures. Thus the context of the bone anchored hearing aid care procedure is rather complex to define and describe. However, by gathering information from observations and interviews with professionals from different Swedish clinics, this chapter aims to provide a general understanding of the context and the requirements for a future demonstration tool. 4.1. Collection of Data Several methods have been used to identify the requirements for a new demonstration tool. Information about the counseling situation, the Baha system and the expressions consistent with the company communication strategy have been collected and analyzed. The main part of the data collected have been of the qualitative type where deeper understanding have been gained trough fewer but more intense collection occasions. 4.1.1. Literature Studies The literature studies have supported the work throughout the entire research phase. Initially literature studies were used in order to build up the understanding for a life with hearing loss and then the studies academically supported insights during the stage of analysis. The literature studies included reading journal articles, exploring books about design for experience, communication strategies and watching online seminars and educational materials regarding the Baha surgery and life with hearing loss. Findings from the articles were clustered to sort out relevant aspects to consider and to condense the information. 4.1.2. Interviews Two interviews conducted at Sahlgrenska University Hospital in Gothenburg the 15th of November 2012, see appendix 3, and Sunderby Hospital in Luleå the 23rd of November, see appendix 4, set the foundation for the study of the context. In total four audiologists have been interviewed; a single audiologist working with adult patients was interviewed at Sahlgrenska, Gothenburg and a group of audiologists, one working with adults and two working with children, were interviewed at Sunderbyn Hospital, Luleå. The intention with the interviews was to confirm the counseling process, how it was described in theory to how it was experienced by the professionals. Moreover the interviews with audiologists aimed to describe the general work and show the tools that are used during counseling sessions. Besides, the interviews aimed to develop the understanding of the different situations occurring, as well as an understanding of the main objectives, needs and preferences of the audiologist. 4.1.3. Observations Two observations were conducted at Sahlgrenska the 6th and 20th of December, see appendix 5 and 6. The first observation was at a candidate’s first time visit to the audiologist. The second observation was a revisit of a candidate who had tried the Baha on a softband for a month. The observations aimed to provide information on how the audiologist actually works. The observed audiologist I 19 was the same person as was interviewed, thus it was possible to compare how the session actually was held to what was told during the interviews. Besides, the observation was the main source of information concerning the candidates. Watching them indeed confirmed the by Cochlear predefined barriers, which the project aimed to address. 4.1.4. Workshop for Audiologists Informal discussions with several audiologist and other professionals at a workshop for audiologists, 4th of December 2012, have contributed to the research and analysis of the counseling sessions. Through the day thoughts and reflections from audiologist with different levels of experience were collected. Thus the understanding of the professional users were further developed. The method of Issue Cards was used during the workshop to get in contact with the participants and initiate discussion around the topic of needs for a new demonstration tool. Another reason for attending the workshop was a seminar by a Baha recipient, explaining his thoughts and journey from getting a Baha to living with it for many years. 4.1.5. Study of Expression In parallel with the context exploration, a workshop on expression was prepared and held at Industrial Design Engineering department at Chalmers, the 13th of December 2012, see images 10 to 14. The workshop aimed to bring out ideas on how to generate an expression in line with the company strategy. From which, the desired expressions had been identified through use of the design analogy method on the core values; ease of use, reliable performance and aesthetic design. The workshop was held to involve a larger crowd in exploring what was associated with the desired expressions and participants were asked to modify a white plain box by shape, material or by other means in order to match the requested expressions. The workshop structure sprung from the method “Design the Box” but here participants worked individually. The participants were furthermore asked to explain their ideas through illustrations or descriptions on small paper sheets. The expressions looked for were inviting, honest, and selected. In the room three boxes where placed with an expression and additional moodboard each. The question asked to the participants was “How would you make the box more…?”, followed by each expression. The workshop was open during three hours over lunchtime where participants could casually walk in and join. The participation required about five to ten minutes and was conducted anonymously and all ideas were gathered in a big carton box. The setting was neutral and relaxed with white walls, music and color pens at disposal. When closing, 25 individuals had taken part in the workshop and their answers where compiled in an excel sheet. For each expression the ideas where listed in a table and it was noted how many times they reoccurred. In addition to the workshop on expression, a Design Format Analysis (DFA) was conducted to analyze Cochlear’s current product portfolio. The products studied were the sound processors and not the current supportive tools. Firstly, the sound processors were selected to assure that the demonstration tool would fit with the Baha system. Secondly due to lack of supportive tool offerings and consistency in supportive tool portfolio. Development of a Demonstration Tool for Bone Anchored Hearing Aids Images 10-14 clockwise: workshop participants, the set up of expressions and boxes, honest, inviting and selected, drawing, and writing thoughts and ideas with color pens on note paper. I 21 4.2. Context Description The following chapters will sum up the research and data collection and account for the obvious result outcome and also be a subjective analysis of how the context as a whole comes together and builds up a need of a new demonstration tool. The research shows that the general candidate journey consists of four phases, see image 15. The context description will focus on the counseling phase. 4.2.1. Users Medicine technical equipment generally has two primary users: • The patient who gets the treatment • The health care personnel who direct the machine Accordingly, for the development of a new Baha demonstration tool both the candidate and the audiologist will be considered primary users. The candidate interacting with the tool in order to get an understanding of the Baha system and the audiologist using the tool in order to facilitate the explanation to the candidate. Parents to children who might get a Baha will also be considered primary users but are not considered in this particular project. Secondary users will for the demonstration tool be Cochlear who tries to get the Baha solution more desired. Potential co-users are interpreters, friends or family who might have joined the counseling meeting. Friends and family could also at times be considered side users. Baha Audiologists • Background The audiologists are one of the two primary user groups. In Sweden the audiologist educational program is held at four various universities. The program holds 180 credits, which means three years of fulltime studies. The audiologist program is cross-disciplinary including technical, medical and behavioral sciences as described by the national admission office in Sweden. Like in several other professions the level of experience of the audiologist working with Baha solutions depends on the numbers of patients treated. Some in the profession only work with the Baha solution while others have it as one solution among many other hearing aid solutions for patients. The Swedish Baha audiologists are specialized in either Baha for adults, people above 18 years old, or children with their parents attending the counseling meeting, see appendix 3 and 4. When not having Baha patients frequently it is likely that the counseling procedure has to be reviewed before each new appointment, see appendix 4. The audiologists could work at hearing clinics and hearing centers, in private or public sector. They could also work for the developers or within the industrial, school or children health services (KI, 2013). • Use The counseling work includes getting an understanding of the patient, explanation and display of the Baha system, individual adjustments, evaluation and journal writing. The hearing experience is always tried out by allowing the candidate to experience hearing through the skull bone by wearing headbands or softbands, which the audiologist provides the candidate with during the meeting. The work of the audiologist also includes setting individual programs on the sound processor through computer software provided by Cochlear and feedback given by the candidate. The frequency of performing Baha counseling varies greatly from audiologist to audiologist. E.g the interviewees from Sunderbyn Hospital had a patient frequency of approximately five candidates a year whereas the audiologist interviewed at Sahlgrenska claimed to have two counseling appointments a day. Depending on the frequency, the mental model of the counseling and Baha solution differ from rather vague to very clear. The arrangement at the specific clinic also seems to vary. For instance, as overheard during the workshop for audiologists some clinics used to have special days only treating Baha counseling and Baha surgeries, however, due to re-organizations this set up was not longer possible wherefore a close collaboration and dialogue between the audiologists and surgeons were more difficult to sustain. • Influence and Responsibility The details on the counseling content depend on the candidate involved, current knowledge, interests as well as the preferences of the specific audiologist. Factors Image. 15. Counseling Phases Development of a Demonstration Tool for Bone Anchored Hearing Aids like children being too young to explain their own situation with the presence and behavior of parents, as well as a potential presence of an interpreter to help language barriers effect the set up of and emphasis during the meeting. • Emotional Relationship The emotional relationship to the Baha system and counseling vary depending on experience. The interviewed audiologist at Sahlgrenska was confident and experienced in handling the Baha system and counseling procedure whereas the audiologists interviewed at Sunderbyn Hospital had a less confident relationship. • Type of Interaction The interaction to the system includes both cognitive use and physical handling. • Activities, Goals and Motivation The main objective for the audiologist during counseling is to help the candidate in gaining knowledge of the options available, which could improve one’s hearing. The guidance is likewise to inform and provide facts and options and definitely not to sell the Baha solution. As a result of that, the trial of the hearing experience through head- or softband is the main argument for the Baha system. The goal is to give the patient an accurate picture how he or she would find the solution if moving forward in the process. Baha Candidates • Background The candidates are the other primary user group. The group is heterogeneous, ranging from very young children to elderly people far above the age of retirement. Not only the age but also the previous experience of hearing is extensively diverse. In counseling of very young candidates, the parents are also considered primary users and are treated almost like candidates, although they are not. • Use Some candidates have lived for several years with other hearing aids, experiencing similar hearing as would be obtainable by the Baha. Other candidates have no previous experience from living with hearing aids and have only lived with impaired hearing without using any aids at all. • Influence and Responsibility For an adult the reflection and furthermore decision upon the hearing is done for oneself. For a child it is the parent, who tries to understand the effect the offered solution will have on the quality of life of his or her child, who mainly makes the decision. • Emotional Relationship Currently the Bahas are often considered when no other options are available. Either it could be due to that sufficient hearing cannot be obtained with other aids or that the candidate has tried other aids but experienced lots of issues so the situation has to be improved. Please see chapter 2.2 for information regarding the causes. • Type of Interaction The interaction with the Baha system is physical when trying the hearing experience on a softband. For getting an understanding of the system, the current interaction is mainly cognitive. For a parent, the counseling would be mainly cognitive; although one can try the hearing experience itself the hearing experience of its child cannot be completely obtained. • Activities, Goals and Motivation The counseling is for the candidate a step in deciding if something should or could be done in order to improve the hearing or the current situation living with hearing loss. Besides, as was identified during the observation at Sahlgrenska 6th of December 2012, see appendix 5, the main intension during a counseling session is for a candidate to understand why their current situation is as it is. That could be that the candidate mainly searches for an answer that lies in the diagnosis done by a doctor rather than the audiologist. The main reason for getting a Baha is for a candidate to improve the hearing and the life quality e.g. when the candidate cannot live without hearing aids anymore or when having issues with other hearing aids. 4.2.2. Barriers – why refraining from Baha When patients classify within the three types of hearing loss, previously mentioned in chapter 2.2, they become candidates for the Baha system, meaning Baha is a sufficient aid to their hearing loss. When patients choose to take on the Baha system they become recipients. Some persons might qualify for Baha but still chose not to move forward with the aid. There can be various reasons why possible candidates for a Baha do not end up with the solution. Refraining factors can origin from the healthcare sector or from the patient itself. Professionals not being too familiar with bone anchored I 23 hearing might not know when to recommend the solution or even think of it as an option. Bone anchored hearing aids are not as common as conventional hearing aids and therefore sufficient knowledge and comfort of providing information about Baha might not be available by the individual audiologist. Regarding the patient there are five identified barriers by Cochlear (Appendix 2 and Design Research Report 2012). These are reasons for why the patient itself refrains from the Baha solution. 1. Aesthetics is a barrier to choose the Baha system as the candidate is concerned about size of the sound processor, that it always shows (especially with shorter hair) and is placed at different place than conventional hearing aids. 2. The surgery can be a barrier for patients that for some reason fear it, possibly based on previous experiences or assumptions made regarding its complexity and risks. 3. The implant is identified as a barrier as some candidates find it troubling that it comes out of the head and that something is implanted into the head. 4. Funding can be a barrier for candidates in some countries as insurance approval can be difficult to get. Policies can also vary in different counties in Sweden. 5. Perceived hearing outcome can be a barrier if the candidate is not convinced when trying on the softband. The softband experience is not good enough to make the candidate follow through with the Baha solution. 4.2.3. Observational Study Two observations of the work of an audiologist at Sahlgrenska were arranged along the research and analysis., see appendix 5 and 6 The observations provided insights about the actual behavior of the audiologist and candidates during the counseling sessions. The first observation was done on a first time meeting between the audiologist and a middle-aged woman experiencing issues with runny ears when using her conventional hearing aids. The woman had visited her medical doctor prior to the counseling. It was recognized that the audiologist, during the counseling, uses gestures, shows brochures and one or more product samples in order to convey an understanding of the bone anchored hearing aid system. The discussion was general and no brand specific clarifications were done. Although the by the audiologist explained intension is to provide an objective presentation of all the appropriate sound system choices, the observations at Sahlgrenska showed that the candidate might only get one option presented before the test period on a softband. Latter stated by the observed audiologist, there could be several reasons for only displaying one option initially. Relevant factors such as time restraints, e.g. when using an interpreter, the amount of processors in stock and if a right or left placed processor is required, effect the amount of displayed system options. The audiologist moreover explained that e.g. the competitor Oticon offers different processors for each distinctive placement side, whereas the Cochlear processor is universal for both sides of the head. The actual reason for only exposing and suggesting one processor at the observation was not clarified. The dialogue during the 40 minutes counseling was a bit pushed and there was not much time for discussion. Potential reasons could be the delayed start of the meeting, the element that an interpreter was used or it did simply expose the general behavior of this very experienced audiologist. At the second observation a revisit was observed. The patient, a middle aged woman, had tested a softband for a month and basically came back to explain that she was not ready for the bone anchored solution. The candidate could clearly see that her hearing benefitted from using the device, yet she was not ready to welcome a solution that penetrates the skin and is implanted in the skull. She further explained to the audiologist that it was not the surgery that frightened her. Instead it was simply the fact that something would stick out from her head. Conversely to previous observation, the patient was the one leading the conversation during the counseling. The audiologist, the same one as during the first observation, primarily listened to the candidate and confirmed the feeling of the candidate by nodding and letting the candidate continue to talk. When the patient had finished her explanation and handed back the softband, the audiologist asked if she wanted to try it for a longer period. The audiologist furthermore explained that a doctor at Sahlgrenska holds tests on a new magnetic solution that would not go through the skin. Instead a magnet under the skin would make it possible to attach the processor. The candidate got very positive to the idea and instantly wanted to join Development of a Demonstration Tool for Bone Anchored Hearing Aids the study group. As she had experience from clinical studies, she knew that these are nothing to worry about, she said. The meeting was very short and the audiologist clarified, directly after the meeting, that it is not her task to convince the candidates, solitary to display the options available. This correlated well with the perceptions gained during the conducted observations. 4.2.4. Demonstration Material During Counseling The companies trading the bone anchored systems have each developed several demonstration tools that aim to be used during the counseling, see image 16. Observations at Sahlgrenska University Hospital have shown that besides facilitating the work of the professionals, the demonstration tools that are used try to enhance the candidate’s understanding of the product offerings and their likely results. In addition to the mentioned functions, these tools also promote and certify the quality in which the audiologists present the companies’ product offerings. At the place for the observational studies, there were two product brands available. The two companies offered similar demonstration tools for product display and practicing use of the system, see the illustration and explanations in image 16(E). The cylindrical tool, shown in image 1, by Cochlear is the main reference product for this Master’s Thesis. The two demonstration tools are both made in Plexiglass. They offer a possibility to attach and detach the sound processors to abutment, yet they give neither tactile nor visual resemblances to the actual placement and visual appearance on a recipient. Simple shapes, a cylinder and a triangular prism, are used. Although none of the two tools give resemblance to the real use, the inclination on the triangular prism gives a slightly more truthful angle of display than the horizontal position on the cylindrical shape. As seen from the observations and interviews, the Softbands and headbands (A and B) are used to give the possibility to try the hearing experience prior to surgery. This to further evaluate the individual hearing need and to get a good understanding of what hearing experience to expect. Brochures (C) supplement with visual samples of how the system will look on the patients after having a surgery. The audiologist does not necessary show neither the same brochure as sound processor, nor the latest brochure provided by the companies. The main objective of the audiologist is to show true illustrations of how the patient could expect the results to look. Product samples (D) are available at the counseling in order to see the included components and available choices. Demonstration tools (E) are supposed to be used for displaying and practicing attach- and detachment of the sound processor. Image 16. Demonstration material used at counseling A B C D E I 25 reference tools are currently not actively used except for storing and occasionally showing product samples to the candidates. 4.2.5. Market Competition Cochlear has identified the market competition as the following image 17, which includes companies and solutions that can be alternatives to their own Baha system (Pettersson, 2012). Percutaneous bone anchored hearing aid is what the current Baha solution is today. The abutment goes through the skin and the sound processor above the skin receives sound vibrations. Passive transcutaneous bone anchored hearing aid has the abutment part under the skin and thus the skin is never pierced. Sound vibrations are led through the skin, which muffles the sound. Active transcutaneous bone anchored hearing aids have the abutment part under the skin and thus the skin is never pierced. The audio processor picking up sounds is placed above the skin. The vibrating part transferring sound vibrations is placed under the skin. Non-surgical aids are indirect competition as e.g. CROS and BiCROS hearing aids can be used for the some types of hearing loss that Baha can improve as well. CROS hearing aids treats single sided deafness by transmitting sounds from the poorer hearing ear to the better ear. BiCROS does the same but also amplifies the sound if the better ear suffers from conductive hearing loss. Percutaneous Baha Transcutaneous Baha Passive Transcutaneous Baha Active Non-surgical Hearing Aids Implant goes through the skin. Vibrates above skin layer Oticon Implant does not go through the skin. Vibrates are led through skin layer Shophono Less softer values due to new technology Implant does not go through the skin. Vibrates under skin layer Bone Bridge No bone conduction CROS hearing aids Market competition Image 17. Market Competition Development of a Demonstration Tool for Bone Anchored Hearing Aids 4.2.6. Cochlear Strategy By use of three core values; Reliable Performance, Aesthetic Design and Ease of Use, Cochlear wants to build a customer centered strategy built on meeting the customer needs within guiding principles such as simplicity, aesthetics, reliability and value creation (CBAS Communication Strategy, 2012). The strategy aims to increase the trust and love to the Cochlear brand and products, as shown in image 18. The end users are the primary target group, whose needs all communication should build on. However the company speaks to the end users through professionals being Baha audiologists and surgeons. The target groups are divided as follows in image 20. The strategy claims that the Cochelar’s products are not sold through features. Instead the softer values and benefits that emphasize the company core values will build the foundation in the communication to all the addressed target groups, see image 19. 4.3. Analysis Conclusions The conclusions of the analysis have been drawn with focus in identified needs and requirements for the new demonstration tool. The findings are subjective yet verified with company representatives. All analysis areas are considered and finally concluded in a requirements list for the new demonstration tool. 4.3.1. Counseling Journey As explained in chapter 2.5 Design Theory, numerous perceptions build up to one entire experience. The Counseling Journey Canvas, image 21 maps the main insights from the counseling context study and concludes the overall counseling journey as it is designed today. The Journey is divided in three phases; Pre-Counseling, Counseling and Post-Counseling. Image 18. Trust vs Love Image 19. From Features to Message Image 20. Target Groups I 27 Image 21. Counseling Journey Development of a Demonstration Tool for Bone Anchored Hearing Aids 4.3.2. Personas The user profiles and observations set the foundation for three personas. Each represent a user segment for which the demonstration tool could balance up their drivers in regarding helping aids for hearing loss. Anna wants to stay herself, Kent wants to keep his harmony in life and Ruth wants her patients to be satisfied with their decisions. Anna is 29 years old and works with sales at a company providing applications within construction. In her free time she likes to go out and spend time with her friends. Fashion and trends are one of her great interests. Almost a year ago Anna was caught in a serious car accident. She got severe injuries onto the ear canal and the middle ear bones got damaged. This caused her hearing to become very reduced on one ear. Her profession involves customer meetings at noisy construction sites, which now are obstructed mainly because of her hearing reduction, restaurant visits with friends are also difficult. Her hearing is reduced to such a degree that conventional hearing aids are not sufficient. Baha, a bone anchored hearing solution, would give Anna a much more improved hearing experience, which she has also experienced at a try out. Her hesitation concerns the aesthetics that comes with the sound processor and implant. To live with Baha would constantly remind her of the accident. She is afraid that she will not feel and look herself with an implant coming out and the sound processor attached to the head. She is also worried that people might treat her differently seeing her hearing aid. I 29 Kent is 70 years old and as retired he spends most of his time at the house, in the garden or out on walks with his dog. With age his hearing has become reduced on both ears, yet a bit more on one ear so today he uses CROS hearing aids. He notices that he has a hard time keeping up in conversations with a group of people and that he does not hear when somebody calls his name or the doorbell rings. Since the hearing reduction has occurred gradually Kent has partially adapted to it and developed own communication strategies. He turns his better ear to the sound source, reads on lips and avoids certain contexts he experiences as difficult. It is hard for him to have a reference as the reduction has occurred over time, his family and friend on the other hand notices and have spoken of the difference. For Kent the Baha solution would be implanted on both ears. Yet there are some worries to deal with before Kent feels comfortable with particularly the surgery. Some years ago Kent had meningitis, which was experienced as very unpleasant, and he is now worried about what complications might arise from this needing to operate on the skull bone. Furthermore he has done a knee surgery where the outcome was less than expected and healing took longer than planned. With these experiences he is afraid that also this operation will not heal properly and that he might find it difficult to take care of the implant as the side of the head is hard to reach and see. Development of a Demonstration Tool for Bone Anchored Hearing Aids Ruth is 41 year old and has educated herself further to work as an audiologist after several years within the healthcare sector. She is located in a smaller county region where patients with all kinds of problems related to hearing loss visit her. Her role thereby involves knowledge of various hearing aids and possible interventions to pursue, from conventional aids to CROS, Baha and Cochlea implants. Due to her long career within the healthcare sector she feels confident meeting patients and judging their emotional and physical state. Ruth thinks it is the rewarding part of her work as she is good at handling the patients core problem making them feel seen and heard, and she often gets positive feedback from the ones she meet. Although she finds it exciting to develop a new knowledge area growing in the role as an audiologist it is also a bit nervous. Most types of hearing loss results in conventional hearing aids but when patient problems require other solutions she feels a bit lost. Ruth appreciates the neutral role she has as a healthcare professional and does not want to come off as selling products to the patient. She does not work with the Baha system that often, and when she is to meet a potential Baha candidate she has to take extra time to prepare herself. She uses the company provided material when discussing with patients, but she feels like it is mostly a monologue by her during counseling. Trying to explain the system to patients she feels like she does not come through with the information and she feels pressured as the consultation time is only set to one hour at the most. I 31 4.3.3. Trends Throughout the analysis several trends important for developing a new demonstration tool, were identified. Considering the counseling in particular, the trend of communication characterized by emotion is growing. It was noticed that competitors successfully use soft values in their argumentation towards the candidates, e.g. on their websites. Besides, as identified by Cochlear (Design Research Report, 2012), ergonomic feel drives user preference to the design as has been shown e.g. in the Ponto solution by Oticon, in which the curves and ear-like shape suggest harmony. In comparison, the Cochlear BP 100 was perceived less ergonomic and more old-fashioned. Another trend is the rapid technology development, particularly concerning the implant and abutment. Technology inventions have resulted in new competitors entering the field and will moreover make firms offer more than one type of option regarding implant and abutment combination to the candidates. Thus the candidate’s number of options increase, which makes the work of the audiologist a bit more difficult. Today the audiologists “sell” the Baha solution primarily by the “try before you buy it” approach, which by now only includes the trial of the hearing experience through a test period on a head- or softband. Re-organizations of the healthcare clinics combined with the individual´s professional interests have increased the distance between the anatomical, audial and surgical knowledge and thus probably impaired the prospects for the candidates to get a holistic understanding of the system offer. 4.3.4. SWOT Launching new products and tools, Cochlear’s strengths concerns them having the most experience in the field of Baha, see image 22. In combination with their quality assurance thanks to throughout assessment before releasing new innovations, the Cochlear choice should come through as very safe to the recipients. New surface treatments also make the Cochlear surgical outcome less visible. A potential weakness identified is that the design seems to be considered rather stiff compared to the more organic shapes in some of the competitors’ designs. The stiffness can be difficult to incorporate with softer values aimed for in the company strategy and come through as friendly when presented with supporting products. Regarding the development of a new demonstration tool, economical limitations might also affect the number of concepts possible to realize. Whilst many barriers make candidates refrain the Baha Image 22. SWOT Analysis Development of a Demonstration Tool for Bone Anchored Hearing Aids solution, the actual operation is very safe and although one could get infections, one could not actually worsen the hearing. Thus there is a gap to fill in explaining the surgery and life with Baha, then changing the perception of the action of getting a Baha from frightening to fairly inviting. As there would be a need for filling the gap, there is an opportunity to be the first one with a new tool, thus increasing the attention during counseling. Through development of a multifunctional tool, there would also be an opportunity to replace several minor sources of information, like different pictures and brochures in order to better bond to the candidate. The general threats for introducing new tools for the counseling sessions are that although a new Cochlear tool is used, the candidates might not get committed to the solution. Secondly a threat would be that the audiologists do not use the new tool at all. It has been noticed, at the workshop for audiologists, that the audiologists do actually not use numerous tools offered by the producers and even if the audiologists do use the tool, Cochlear has no control of the actual conversation at the session. The lack of control over the middlemen might have great effects on the success of new inventions. At last, one threat is that the highly technical mindset at Cochlear might affect the audiologists’ attitudes when talking to the candidates. Thus the softer argumentation expressed in the strategy threats to be dissolved through the deeply rooted technical mindset in the company. 4.3.5. Design Format Analysis (DFA) Table 1 shows that in general the Cochlear sound processors have very clean cuts and rectangular sharp shapes. No patterns or textures are used. Looking at the design format analysis it shows that the BP 100 and the BP 110 are the most consistent products. Least consistent is the Baha Cordelle mainly because it is body worn. The most consistent design elements are sharp radius from side to front, four cornered shape, buttons only at side, decentralized division line at sides and symmetry of entire product. The sound processors basically come in four different Table 1. DFA I 33 colors (blonde, black, grey and brown) to match the hair. The surface is matte and shimmery. For the BP 100 a broader range of different colored side covers and fronts are available, the colors are not only natural but also include brighter shades. Preferably the demonstration tool will use similar design elements as defined in the DFA, yet the tool need to have a subtle shape to enhance the importance and display of the actual Baha system and come through as pleasant. 4.3.6. Strategy alignment In order to increase the strategy alignment the sound processor ought to be perceived more ergonomic and aesthetically up-to-date. Regarding the performance, the current products are perceived as reliable. To better align the product offers to the Company Core Values, the new demonstration tool must try to progress the candidates’ view of the sound processor experience to an ergonomic and preferred choice, whilst the design format still comprises sharp cuts and rectangular shapes.The interpretation of the company core values to the demonstration tool expression resulted in the requirement of the tool being inviting, honest and selected in its expression referring to the company core values ease of use reliable performance and aesthetic design. 4.3.7. Workshop Outcome The conducted workshop on expression resulted in several characteristics complementing each requested expression, explained in previous chapter. The most frequently mentioned thoughts are listed in table 2 and some collected idea sheets are shown in image 23. Expression Characteristic Occurrence Inviting Round shape 10 Smooth shape 7 Chiseled out/Concave 6 Selected Nice to hold 5 Elevated 10 Indicated 7 High-class material 6 Precise form 6 Beveled edges 6 Honest Transparent material 12 Organized dimensions 7 Homogenous coloring 5 Clean surface areas 5 Table 2. Workshop Outcome Image 23. Workshop on Expression Development of a Demonstration Tool for Bone Anchored Hearing Aids 4.3.8. Need and Potential in a New Demonstration Tool The impression is that there is an opening for a new tool that would be used by the audiologist for showing the Baha system location on the head. Especially for showing the visual looks and for explaining the ear anatomy and sound travel. Yet the group is sensitive to material that could be perceived like commercial. Their main interest lies in the hearing experience and they are not employed for convincing the candidates. Instead they are employed to inform and show the options that could help the candidate to improve their hearing and experienced quality of life. Today the explanation of the Baha system is according to the research exclusively done through the display of real example pictures and sample products. Thus no tactile feedback and relation to the body is conveyed to the candidate, who does not build up any further relationship to the system than the one conveyed through the hearing experience trial via the head- or softband. Use of tactile stimuli in addition to audio and visual stimuli would certainly be an opportunity to address the reasons for refraining the Baha system and instead build a relationship and affection for the aid. The interviews and observations show that the reference product, the plexiglass s