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Dresden, 23 June 2023. Thanks to an invention from Saxony, a throbbing earache may be cured more quickly as early as next year: The Fraunhofer Photonics Institute IPMS in Dresden has built a tiny ultrasound sensor that can use ear secretions to recognise whether a middle ear infection has been caused by bacteria or viruses. IPMS Director Prof Harald Schenk estimates that upgraded otoscopes could receive approval and come onto the market as early as 2024 in response to an enquiry from Oiger.
No more pointless antiobiotic prescriptions „on suspicion“
for ENT specialists in futureOn the one hand, the new otoscopes should help children with ear problems in particular to find relief more quickly. On the other hand, they could lead to diagnoses that are twice as accurate as today and avoid many unnecessary antibiotic prescriptions if the doctor mistakenly suspects a bacterial middle ear infection, emphasises Schenk. „Unfortunately, antibiotics have often been wasted up to now.“ And this should be prevented in view of the increasing number of multi-resistant germs.
Mini-capacitor transmits and receives ultrasound
The new sensors consist of two small electrodes with an air gap between them. In fact, the structure resembles a small capacitor. One electrode can vibrate and thus emit ultrasound. These signals, which are inaudible to humans, are then reflected back by the eardrum, whereby the secretion in the ear canal distorts this echo, depending on how thick the mucus is. The sensor, which is also the receiver, finally picks up the echoed ultrasound with a membrane and converts it back into electrical signals. Because of this dual function, the tiny component is called a „capacitive micromachined ultrasonic transducer“ (CMUT), i.e. a capacitive micromachined ultrasonic transducer.
Secret density reveals whether bacteria or viruses are growing
A special software finally analyses the echo. The programme can then diagnose whether bacteria or viruses are at work in the ear from the secretion density measured by the echo.
Hit rate increased from 50 to 99
The US medical technology company „Otonexus“ has been working on this issue with IPMS Dresden since 2018 and has now incorporated the secretion sensor from „Silicon Saxony“ into the tips of otoscopes. In tests with animals and finally with humans, the Americans achieved very high hit rates: If, statistically speaking, most ENT doctors are wrong in about every second case when asked "Bateria or viruses?", the upgraded ear viewer comes to over 99 per cent.
Sensor series production to start quickly in Dresden cleanroom after FDA approval
Otonexus is now awaiting approval of the new otoscopes by the „Food and Drug Administration“ (FDA). If nothing intervenes, production would start quickly and the devices could then enter clinical practice in the USA as early as 2024, predicts Prof Schenk. „We will produce the ultrasound sensors for this in small series in our clean room“, he announced.
Almost every child suffers at least one middle ear infection - and it hurts
Background: Acute otitis media is according to the „German Professional Association of Ear, Nose and Throat Physicians“ one of the most common diseases in childhood. „Statistically, every second European child falls ill at least once in the first year of life“, explain the „ENT doctors in the network“. „By the age of 7, it is estimated that every child has had at least one acute middle ear infection.“ This illness can be very painful and regularly causes young children and their parents to have sleepless nights. In such cases, ENT specialists can clean the ear canals and prescribe anti-inflammatory agents. In the case of bacterial pathogens, doctors often also use broad-spectrum antibiotics.
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