Currently, there are no FDA regulations for noise dosimeters as they do not meet the FDA definition of a medical device. Further, the device will not require Food and Drug Administration (FDA) regulation.
Instead, it will complement these methods by validating enrollment in the HCP, monitoring and assessing a service member’s compliance with HPDs, and quantifying the noise reduction characteristics of the HPD given the unique composition of the member’s outer ear system (pinna and ear canal). This device is not intended to replace traditional methods of dosimetry used to estimate hazardous noise environments in standard occupational settings. This device would prevent interference from the member and/or environmental factors that typically impact noise measurements, and could be used in conjunction with the service member’s hearing protection devices (HPD) and/or personal music devices. Extended wear would allow for true measurement of noise exposure during longer time periods and potential revision of damage risk criteria. This type of device would eliminate the need to estimate noise exposure with a transfer function and would account for resonant properties of the ear canal.
To most accurately measure actual noise exposure at the tympanic membrane, a deep fitting (past the second bend of the external auditory canal) in-the-ear dosimeter is needed. Further, it ignores off duty non-occupational exposures such as personal music players, motor vehicles, and recreational events.Ģ) Regardless of the quality or type of dosimeter, actual noise exposure to the member is still an estimate, and can fluctuate by 10-15 dB based on resonant properties of the ear canal. In some operational environments or deployed settings, exposures can be varying or ongoing and not defined to a specific duty shift. (2) This standard method creates two specific problems in regards to calculating noise exposure for a service member:ġ) It limits the noise exposure assessment to an occupational work period. These dosimeters can provide inaccurate measurements for many reasons, to include the anatomy of the pinna and ear canal, head and body shadow effects, and environmental effects. Although this method is standard for identifying environments with hazardous noise, it does not give a true measurement of actual noise exposure to the service member at the tympanic membrane, because it relies on a mathematical-based transfer function to estimate actual exposure at the tympanic membrane. (1) Hazardous noise levels are identified by measurements from a body-worn (shoulder-mounted) or near-ear (attached to pinna) dosimeters. If the noise levels are deemed hazardous, personnel are enrolled in an occupational-based hearing conservation program (HCP) as mandated by the Department of Defense. OBJECTIVE: Develop a deep fitting in-the-ear, extended-wear acoustically transparent dosimeter to accurately measure levels and amount of noise exposure near the ear drum.ĭESCRIPTION: Military members are exposed to various levels of noise during routine and expeditionary operations.
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