Broadband acoustic ear echo spectrometer
City: Kyiv
Project manager: Serhii NaidaDegree of project readiness: Pilot items
The project proposes a new broadband method of determining quantitative individual parameters of the norm of the middle and inner ear and an acoustic ear echo spectrometer for its implementation.
The diagnostic method consists in observing a pulsed sound signal that is reflected from a drum membrane.
The device will be used for neonatal hearing screening and for accurate diagnosis of hearing disorders of patients in acoustic injuries.
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Project site https://www.sikorskychallenge.com/invest
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You can ask your questions about the project through the comments form
I have three questions: 1) What is your plan for testing the device on infants and children? Will you do a side-by-side comparison with current testing methods? 2) Will you need regulatory approval to enter the market? If so, how much will a clinical trial cost? 3) What do you estimate as the cost to screen a single infant or child? Who will pay for universal screening of newborns?
ReplyDelete1) It is planned to test the ear acoustic echo spectrometer on newborns and children on the basis of the State Institution of National Academy of Medical Sciences of Ukraine "Professor O.S. Kolomiichenko Institute of Otolaryngology”, between which and the Department of Acoustic and Multimedia Electronic Systems of Igor Sikorsky KPI an agreement on partnership and cooperation in the field of acoustics and acoustoelectronics has been concluded. During the tests, comparisons will be made with such methods as otoacoustic emission registration and acoustic impedancemetry.
Delete2) To enter the market, it is necessary to carry out the actions provided by the “Technical Regulations for Medical Devices”. The cost of such actions has not yet been estimated.
3) The problem of objective diagnostic of hearing in newborns, according to recent publications, has seriously worried the medical community around the world. Many thousands of newborns have already undergone a hearing screening program that includes measurement of otoacoustic emission (OAE) of distortion products (DPOAE), transient evoked OAE (TEOAE), and auditory brain reflexes (ABR). In addition, acoustic reflex (AR) is measured by the method of acoustic impedancemetry as the change in the flexibility of the eardrum when broadband stimulus of sufficiently high intensity is fed into a hermetically sealed external auditory canal through an acoustic probe. However, the problem of differentiation of disorders between the sound conduction system of the middle ear and the auditory analyzer (curl, nerves, brain) remained unresolved. Due to the fact that the OAE method is quite expensive and requires highly qualified medical stuff, OAE is used for hearing screening for children in the United States, Germany, the United Kingdom and several other countries. In Belgium, ABR registration is used for this purpose. However, in most even economically developed countries, there are no government programs for hearing screening using effective tools. They are also absent in Ukraine. The goal of the project is to develop a new effective method of objective audiometry, which should be the basis of the program of universal screening of newborns in Ukraine, and which would reduce the possibility of medical error to almost zero and does not require high qualification of medical stuff, and broadband electroacoustic audiological instruments for its implementation. Now Ukraine already has a project "Procedure for screening children's hearing." This project provides: 1) Primary screening of newborn hearing directly in the health care facility where the child is after birth. 100% of newborns are subject to examination, regardless of the presence or absence of risk factors for hearing loss; 2) Secondary hearing screening of newborns before they reach the age of one month, if during the primary hearing screening of the newborn the result "screening failed" is registered (either one or both ears are failed to get the result "screening passed"), in the nursery polyclinics, at home or in the conditions of the medical and diagnostic center; 3) Hearing screening of children of primary preschool and preschool age before enrollment in preschool education, but not later than reaching 3 years of age, and before enrollment in general secondary education, but not later than reaching 6 years of age, respectively, in a health care institution at the place of observation and / or provision of medical services to the child, provided that the necessary equipment and medical staff are available in such institution. After the adoption of the Procedure, hearing screening of newborns and children will be carried out at public expense. Until the Procedure is adopted, it is advisable to carry out all stages of screening on a commercial basis through the numerous deaf and dumb and medical diagnostic centers. Taking into account lower cost of the device comparing with competitors, the price of such express diagnostics will be available to the general public.
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