EU Regulation-EN

EU regulation 2016/425

Because of EU regulation 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment (PPE) there is an obligation to register a sealing test for tailor-made hearing protection. The regulation refers to tailor-made in ear hearing protection (earpiece). More information on this regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016R0425&from=EN

The equipment we developed, the Leakage Tester, does the sealing test by means of applying a small overpressure (5mB) in the ear canal (meatus) between eardrum (tympani) and the protective earpiece. The app controls the tester through Bluetooth® Low Energy (LE). The test is fast and easy. The app draws a graph of the pressure profile during the 5s test, for the hearing care professional to be evaluated. The resulting graph can be saved (registered) with a name and date/time stamp for each ear. In this way the producer can prove that the earpieces were correctly fit on the client and the client can prove to e.g. the employer that he or she has good hearing protection.