What are the current developments in research into deafness? What sort of new discoveries can we expect over the next few years? The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM intends to use its High-Performance Center Translational Biomedical Engineering to find answers to these questions. The institute has been carrying out research for almost 40 years, primarily in the areas of pharmaceutical development and chemical safety. Over the years, the researchers have built up expertise in the field of translational biomedical engineering. One of the topics is the development of individualized implants for people with impaired hearing. In an interview, the director of the Institute, Professor Norbert Krug, explains how deaf people will be able to fully enjoy concerts in the future, and what 3D printing has to do with this. Other topics: how Fraunhofer ITEM makes the lives of premature babies easier and how it can help people who have respiratory diseases through the use of safe and effective medication.
Norbert Krug: The format of high-performance centres was developed by the Fraunhofer-Gesellschaft to connect Fraunhofer Institutes with universities on a local level. This applies to the Hanover Medical School and Leibniz University in Hanover. Fraunhofer experts work in the High-Performance Centre alongside researchers from the two universities on themes relating to biomedical engineering. They are focusing on cochlear implants, a type of hearing aid for deaf people which replaces parts of the damaged cochlea in the inner ear. Both sides can provide their scientific expertise in this respect.
Norbert Krug: Cochlear implants shall become more individualized – each one should be unique. This is because the anatomy of the cochlea is different in every person. Hearing can be dramatically improved if you can make the right cochlear implant to suit every individual. Very little progress has been made with standardised manufacturing methods. This led to the concept using 3D printing. When you measure the brain and the cochlea – via a CT scan, for example – it is possible to design a customised implant for every individual with millimetre precision which can be printed out on the spot by a 3D printer. The High-Performance Centre is aiming to drive forward the use of this technology.
Norbert Krug: They can even hear concerts! This has never been possible until now. Cochlear implants transfer acoustic signals into electric impulses and send them to the brain, where they are converted into sounds. Even though it is possible to distinguish between different sounds when using conventional cochlear implants, it is not possible to hear more subtle differences. The higher the current transmission, the easier it is to hear. If the cochlear implant can be fine-tuned, people with hearing impairments can expect to enjoy a much higher quality of sound.
Norbert Krug: This is going to take a few more years. Patent applications have already been filed for the implants, however, hearing is a very sensitive area. We therefore have to put stringent safety measures into place before we can release the implant onto the market. The material needs to be pliant, well tolerated and should last for a long time, particularly in view of the fact that we have a growing ageing population. It is also important that the immune system be able to properly accept the implant. In addition, we are still missing one vital component: the 3D printer itself. At present, it does not exist in the special form we need.
Norbert Krug: Premature babies need a specific substance called surfactant to enable their lungs to develop. We have developed a new inhalation device at the institute that very effectively administers the required amount to the child. Up to now, a tube has been necessary to spray the substance into the child’s airways under general anaesthetic. The new device distributes the substance around the lungs just as effectively, but it only needs to be placed on the nose, avoiding any excessive stress for the premature baby. There is already a prototype of the inhalation device, however, further laboratory tests are still pending, which means it won’t be ready for clinical use for three to five years.
Norbert Krug: When we talk about research into respiratory conditions, on the one hand we are talking about the development of medicines that will prevent lung disease, and on the other hand research into the risks of airborne substances, be it chemicals or dust. For almost 20 years, the Fraunhofer ITEM team in Hannover has been studying the effects of new medications in humans. This has included both healthy subjects and patients who suffer from conditions such as asthma, allergies and COPD (chronic obstructive pulmonary disease). We carry out these early clinical trials on behalf of pharmaceutical companies. These trials are an important step in the process before the medications are launched onto the market and enable patients to rest assured that they have an effective and safe product in their hands. Before we can test a medication directly on a person, tests in the laboratory must have been completed successfull – these tests are called preclinical trials. We only want to develop methods and models that avoid, or at least minimise, the amount of testing on animals. For example, tissue samples from human lungs are suitable for testing. Cells from these types of samples can survive for several days and behave in the same way as cells from an intact human lung.
We test chemicals and particles to determine what risk they pose to the human respiratory tract. In order to do this, we develop models that mirror the human situation as closely as possible. For example, these tests can help us to improve occupational safety and enable general thresholds to be set to protect health. We have focused our research specifically on nanoparticles – small particles contained in products such as sprays and skin creams that need to be harmless to human health. This is not only of interest to consumers, but also to manufacturers who sometimes use nanoparticles to make substances more malleable or make them clean surfaces more thoroughly.
Norbert Krug: A diverse range of expertise comes together in the excellence cluster. An interdisciplinary group comprising physicists, clinicians, biologists, materials scientists and computer experts can all play a part in furthering research objectives. Specialist knowledge from each individual is needed to improve one single product. This type of collaborative research is a fantastic way to pool knowledge and expertise. We obviously benefit from the fact that we are working together as partners, which enables us to develop our ideas and to feel confident that we can uphold the legal basis of our research. We also receive financial support, which helps us to push ahead with projects such as the 3D printing.
Norbert Krug: Collaborative research is the only way to ensure that research can play a role on a global level. The days of researchers working in quiet isolation are long gone. Problems are now increasingly solved in partnership with other scientists and often across national borders. It is only possible to achieve success and to continue moving forward if you are part of a network.
Focus on research into respiratory conditions: Fraunhofer ITEM is one of 72 institutes within the Fraunhofer-Gesellschaft, the largest organisation for application-oriented research in Europe. The research fields are adapted to suit the needs of the people, which means that the work of the researchers and developers at Fraunhofer ITEM will have a big impact on people’s lives in the future.
Infections of the lungs are becoming more and more significant, antibiotic resistance is increasing, and we now need alternative ways to treat respiratory infections. Fraunhofer ITEM is breaking new ground and investigating new drugs and new treatment concepts.
One of the current main issues is assessing the hazards airborne substances pose to humans. All previous findings on this are based to a large extent on tests carried out on rodents. Fraunhofer ITEM scientists carry out research into how potential damage to lung tissue can be assessed without animal testing, and they use this to develop alternative methods.
The average person is regularly exposed to an infinite number of substances, for example gases, aerosols, fibres or nanomaterials, which can enter the body through breathing, through the skin or can be found in food. Fraunhofer ITEM evaluates the toxicological risk of these substances.
For those affected by chronic obstructive pulmonary disease or COPD, every infection can have serious consequences. Early diagnosis and treatment using the corresponding medication are significant in maintaining the quality of life for the patient and for preventing problems with breathing. Fraunhofer ITEM carries out both preclinical and clinical research into COPD, which is one of the leading causes of death worldwide.
For many respiratory diseases there are either no therapies or the therapies that exist are insufficient. To restore the health of ill people or allow them to have a good quality of life, Fraunhofer scientists carry out research into new medicines and therapies using clinical studies. As part of these studies, the subjects have a health check and also receive reasonable compensation.
In the future, hearing-impaired people will benefit from custom-made hearing aids produced by 3D printers: a completely tailor-made cochlear implant that will significantly improve the listening experience. Once 3D printers will have been developed to print the implants, it is envisaged that it will be relatively cheap to produce customised implants in the long term.
Inhalation technology that has been recently developed by the Fraunhofer ITEM will make life easier for premature babies. The breathing aids and necessary medication can be administered via inhalation.
Collaborative research undertaken as part of the German Universities Excellence Initiative brings together very different areas of expertise – this adds greater weight to research findings and makes it easier to release the products onto the market. Research carried out by Fraunhofer ITEM is thus not a utopia, but has the potential to be implemented in a realistic way.