The Vibrant Soundbridge with LP-Coupler system is a new type of middle ear implant, which is an implantable device for patients whose hearing impairment is caused by malfunctioning ossicular chain. In normally functioning hearing system a sound waves cause movement of the ossicular chain that transmits sound to the inner ear. If the ossicular chain, or the inner ear, is damaged, different types of hearing loss occur that may markedly impair patient’s everyday communication.
A middle ear implant amplifies sound conduction and thus improves patient’s hearing. Thus type pf implant has been for the first time in Poland implanted by Prof. Henryk Skarżyński in 2003. – Since then, although the implant construction has changed little, the possibilities of sound amplification have improved significantly – explained Prof. Henryk Skarżyński after the pioneer operation. – The first Vibrant Soundbridge implant were a relatively simple devices amplifying ossicular vibrations through a vibrating transducer fixed with a clip on a long process of the incus. They could not transmit much energy. This modern system can transmit a lot of energy – adds Prof. Henryk Skarżyński. – This implant derives its high power from a new solution which enables its perfect connection with the ossicular chain and thus large sound amplification. This system can be applied in patients for whom older devices were too weak – they could not sufficiently amplify sound conduction in the middle ear so that patient, although his hearing after implantation did improve somewhat, still could not understand some part of auditory information. Patient who received today the newest middle ear implants will be able to perceive sounds unavailable to users of the old type of middle ear implants that I had been implanting in 2003. They will have fewer problems with understanding and communication.
The new system is efficient and safe – there is no risk of damaging the conducting apparatus of the middle ear – emphasized Prof. Skarżyński. – It has another advantage too – it is no contraindication for magnetic resonance scanning up to 1.5 teslas, while the older generation was allowed for MR up to only 0.2 teslas that is today seldom used in clinical practice.
– This new device fills a huge lacuna – it allows treating hearing loss in a group of elderly patients, that will grow larger in time – summarized Prof. Skarżyński. – About 70% of elderly people have hearing problems. Unfortunately, many of them cannot make efficient use of hearing aids and they do not qualify for cochlear implantation either. These patients will have a chance to recover good hearing with a modern middle ear implant. The system is funded by Polish National Health Fund NFZ.
Operations of implantation of the newest system of the Vibrant Soundbridge with LP-Coupler performed by Prof. Henryk Skarżyński have been transmitted life on the Internet, where thousands of specialists worldwide could watch them, as well as all leading experts from all continents gathered in the World Hearing Center.
– Everybody was aware of risk involved in installing the system that is perfectly fitted to the middle ear and cohesive with the ossicular chain – said Prof. Henryk Skarżyński. – The pressure, however, cannot be too strong, because it could cause necrosis of pressured elements. The moment of fitting of the coupler is crucial. It can take 5 or 50 minutes depending on anatomical conditions – emphasized Prof. Skarżyński.
– We have purposefully chosen for demonstration surgeries only difficult cases. Patients, whom most surgeons worldwide would not decide operating. Earlier, we have conducted specimen trials to be up to the responsibility and show these first surgeries to the world – said Prof. Skarżyński, who has conducted in Kajetany already several hundred of demonstration surgeries.
He has been performing them also in many different places in the world, such as Bogota, Manila, Hannover and numerous Easter Europe countries. As he stresses out, each such surgery is an enormous challenge. It is impossible to foresee how the procedure will go. Only after beginning you find out whether there are anatomical conditions allowing fast and efficient implantation. Demonstration surgery always involves some risk. Prof. Skarżyński, however, has been undertaking to perform them since many years, because as he says without them there would be no progress in ear surgery.
Each movement of the hand of Prof. Henryk Skarżyński was being watched by more than 250 specialists observing surgeries on monitors in the Atrium hall of the World Hearing Center. They came to Kajetany from almost all countries in the world, including Saudi Arabia, Argentina, Australia, Austria, Belgium, Chile, China, Spain, Japan, Canada, Kazakhstan, Moldova, Germany, Sweden, USA, Hungary and Italy. The International BONEBRIDGE & SOUNDBRIDGE is a regular meeting of the best in the world specialists in ear surgery, audiology and biomedical engineering, specializing particularly in hearing implants. First two meeting took place in Rome and in Vienna. – It is an honor for me and my team to be chosen to organize the third Symposium. It is the largest international forum of exchange of experience and knowledge about the possibilities of implantation using Vibrant Soundbridge and Bonebridge implant technology, surgical techniques, audiological aspects, indications and limitations – said prof. Skarżyński, who , it should be reminded, not only performed the first in Poland procedure with the Vibrant Soundbridge middle ear implant and first in the world procedure where this implant directly stimulates the round window, but also – in 2012 – performed first in Poland procedure with Bonebridge bone conduction implant.
Hearing implants are a relatively new solution used in treatment of hearing loss. Ever since these implants have been introduced to clinical practice, works on further improvement of models are continued. Scientists work on developing new couplers – elements that connect the vibrating transducer (FMT) of the Vibrant system to the ossicles enabling better stimulation of the round window and preventing transducer slipping out of the round window niche. Promising results of such experimental studies have been presented by many well-known experts.
Subsequent sessions of the International BONEBRIDGE & SOUNDBRIDGE Symposium involved discussion on the benefits achieved by patients with various types of hearing loss using different types of hearing implants. Sharing their experiences, the specialists underlined the need for creating the guidelines and protocols for managing different groups of patients.
Much attention during the Symposium was given to the problem of atresia (obstructed auditory canal) and its treatment. Prof. Mario Zernotti from Argentina in his lecture has pointed out a surprising fact that incidence of this defect is related to latitude. In South America atresia of the external auditory canal is ten times more frequent than in Europe (20 cases in 10 thousand, while in Europe it is 1-2 cases in 10 thousand).
Two days long scientific program of the International BONEBRIDGE & SOUNDBRIDGE Symposium included a dozen demonstration surgeries and more than 30 lectures and presentations. At the end of the Symposium the debaters have addressed the problem of economic assessment of new medical technologies. As a principle, the system of assessment should aim to support the availability of innovative solutions for patients by promoting technologies that give good clinical effects and are acceptable from the economic point of view. Such system, although challenging for companies developing medical technologies, seems to be necessary for implementation in many countries.
Surgery with the new middle ear implant system Vibrant Soundbridge with LP-Coupler has been reported in television: TVP 1 “Wiadomości”, TVP Regionalna (TVP Katowice, TVP Gdańsk, TVP Poznań) “Informacje”, TVP Warszawa “Echa Dnia”, TVN 24 “Fakty po Faktach”, TVN 24 “Wstajesz i weekend”, TVP 1 “Dzień dobry Polsko”, radio reports and internet portals.