Friday, January 4, 2013

Bone Anchored Hearing Aid - Approved for Clinical Studies by FDA

Nytt implantat ersätter skadat mellanöra


Functionally deaf people can have normal hearing with a new implant that replaces the middle ear. The unique invention from Chalmers has been approved by the FDA for a clinical study. Last week was operated on the first patient.
The new instrument, which has been developed at Chalmers, the patient receives a barely six inches long implants implanted just behind the ear, directly against the skull. The technology utilizes the bone to conduct sound vibrations to the inner ear and called Bone Conduction Implant (BCI).

BCI implant will provide perfect hearing, even for those patients who are born without a middle, according to Bo Håkansson.
BCI implant will provide perfect hearing, even for those patients who are born without a middle, according to Bo Håkansson.
- The sound of your own voice you hear to 50 percent by using bone conduction, so you experience benlett sounds quite natural, says Professor Bo Håkansson at the Department of Signals and Systems, Chalmers.
He and his research team have developed a new, unique implant. Unlike the kind of benledningsapparat used today need a new hearing aid is not anchored to the skull with a titanium screw through the skin. The patient need not be afraid of losing the screw and avoid the risk of skin infections around the attachment.
The first operation on 5 December by Chief Mans Eeg-Olofsson, Sahlgrenska University Hospital, and went according to plan.
- When the implant was in place, we tested the function, and everything seems to work as intended so far. Now, the wound heal in four to six weeks before we can turn the hearing aid, says Måns Eeg-Olofsson, Medical Director of the project the past two years.
The technique is designed to handle mechanical damage to hearing, for individuals who have suffered from chronic ear infections, bone diseases or congenital malformations of the external ear, ear canal or middle ear. They often have great problems with hearing. For those rarely work regular hearing aids, which compensates for neurological problems in the inner ear. Bone-anchored devices can, however, provide a dramatic improvement.
Cochlea function may not be too bad to benledd hearing to work.
- Probably, the patient may have a reduction down to 30-40 dB even in the cochlea. How much reduction can be tolerated, we shall try to find out in the clinical study, says Bo Håkansson.

Making the quadratic internal speaker is small enough while effective has been the most difficult problem to solve.
Making the quadratic internal speaker is small enough while effective has been the most difficult problem to solve.
If the technology works, the patients even more to win. According to previous tests volume gets around 5 decibels higher and treble quality better with BCI compared with previous bone anchored technique.
Within a month will premiere patient implant will be activated and adjusted according to the patient's hearing and wishes. Then follow the testing and inspections every three months until one year after surgery.
- Then we end with a new X-ray and new hearing tests. If all goes well, the operations of more patients place in parallel and relatively concentrated in the spring, says Måns Eeg-Olofsson.
The researchers expect to present the first clinical results in 2013. But when is benledningsimplantatet ready for the market?
- According to our plans, it can be done in only one or two years. To the new technology to reach widespread, massive investments already in the development stage, says Bo Håkansson.
Photo: Oscar Mattsson

Two parts - an external audio processor and an implant
The implant is barely six inches long. It is surgically placed just behind the ear, directly against the skull. The coil of the top end work inductively connected to the hearing aid external, visible component, an audio processor, the patient can easily attach or remove the head.

The external sound processor is held in the right place with the help of two magnets. Titanium screw through the skin (in other technology) is replaced by an inductive link that transmits ambient sounds through intact skin to a single receiver. The audio signal is passed down to a square speaker that is anchored in the bone near the ear canal. It produces sound vibrations that reach the cochlea sensory hair body through the skull.
Illustration: Emil Håkansson / Chalmers


Deaf people will have normal hearing and function with BCI
Hearing damage is the industrialized world's most common physical disabilities. If the problem is in the mechanism that will cause the sound to the inner ear - for example in the eardrum or middle ear bones - you can use the leg instead.Soon functionally deaf have normal hearing with the implant in the picture, called Bone Conduction Implant, BCI.
- The solution becomes very comfortable and aesthetically pleasing. Implant secure location inside the skull allows the patient does not need to think about being more careful than other people at eg water sports, explains Bo Håkansson, who leads the research project behind the invention.

Illustrati on Boid / Chalmers


Chalmers and Sahlgrenska in close cooperation since the 70's
in 1977 were provided three adult patients with titanium implants in the bone behind the ear at the ear clinic at Sahlgrenska hospital. This was the starting point for an intimate and long been a collaboration between Professor Bo Håkansson, ear physician and Associate Professor Anders Tjellström and Professor PI Branemark, known for his concepts of permanent anchoring of the implant in the bone, so called osseoimplantat.

The so-called Baha technology (Bone Anchored Hearing Aid) has gradually been refined since then and today helps more than 100 000 patients worldwide to hear better, and the more it becomes. Baha technology has never been spread so rapidly that today. The cross-disciplinary teamwork has survived intact for over 35 years.

More on BCI project
Besides Bo Håkansson and Måns Eeg-Olofsson involved the following persons in the project: Dr. Sabine Reinfeldt and doctoral Hamid Reza Taghavi and Karl-Johan Fredén Jansson from the research team at the Department of Signals and Systems, Chalmers University of Technology, and Professor Anders Tjellström and chief Joacim Stalfors, SU Sahlgrenska, and Professor Carina Johansson, dental department of the University of Gothenburg.

The research was funded by including Vinnova, the Swedish Research Council, National Association of Hearing, Regional Executive funding for R & D, Foundation Acta Oto-Laryngologica, Stingerfonden, Göteborg Medical Society and Kristina Stone's foundation.

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