Studies on the exposure and effects of ultrasound

In addition to the well-known diagnostic and therapeutic medical applications, ultrasound is increasingly being used in non-medical areas such as cosmetics. The aim here is often to reduce fat or wrinkles.

If a manufacturer does not have a medical purpose for its product, it can be sold freely, such as many devices for the aesthetic sector. An exception to this are medical devices that can pose risks when used, such as breast implants. Even if they are not medically necessary, they are still classified as medical devices as they pose a risk to the user.

In the commercial sector, these applications have been regulated since the end of 2020 by the Regulation for the Protection against Harmful Effects of Non-Ionizing Radiation when Used on Humans ("Verordnung zum Schutz vor schädlichen Wirkungen nichtionisierender Strahlung bei der Anwendung am Menschen" (NiSV)). However, this regulation does not apply to private use. This means that devices that can be rented or purchased for "self-treatment", for example, are less strictly regulated and there is a risk that the NiSV will be circumvented.

For example, devices are freely available on the internet which, according to the seller, can be used to destroy adipose tissue (lipolysis). The parameters that can be used to characterize the generated sound field and to assess the effects and side effects are often not fully specified. Furthermore, there is a risk that laypersons do not understand them and are not aware of potential dangers. It is therefore essential to assess the risks associated with the non-medical use of ultrasound devices more accurately.

In diagnostic, medically used ultrasound, there are regulations that are probably only applicable in the higher frequency range, but are nevertheless often transferred to the lower frequency range.

Since the low-frequency range has not yet been researched to any great extent, this project is investigating the potentially harmful effects of low-frequency ultrasound by first reviewing the current state of knowledge in science and technology and then using simulations to investigate the effects of the ultrasound in the body.

Funding

funded by the Federal Office for Radiation Protection

FKZ: 3622S72475
(Project term: 04/2023 – 03/2025)

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