title: Guidelines for Auditory Threshold Measurement for Significant Threshold Shift.
abstract: The purpose of this article is to provide guidelines for determining a Significant Noise-Induced Threshold Shift in clinical trials involving human populations. The article reviews recommendations for the standards to be referenced for human subjects, equipment, test environment, and personnel. Additional guidelines for military populations are provided. Guidelines for the calibration of audiometers, sound booth noise levels, and immitance equipment are provided. In addition the guidance provides specific suggestions for the subjects history before study onset, and otoscopy.Test frequencies for threshold determination and methods of threshold determination are reviewed for both air conduction and bone conduction for both baseline testing and later determination of either a temporary (TTS) or permanent threshold shift (PTS). Once a Significant Noise-Induced Threshold Shift has been determined, subjects should be retested, conductive component should be ruled out or addressed, and the subject should be counseled or referred for additional medical evaluation. Guidance for reporting procedures and the computerized study database are described. Finally, experimental designs suggested for noise-induced otoprotection clinical trials are described.
authors: *Department of Medical Microbiology, Immunology and Cell Biology, Southern Illinois University School of Medicine, Springfield, Illinois †Defense Hearing Center of Excellence, JBSA Lackland, Texas ‡Department of Otolaryngology, University of Miami Miller School of Medicine, Miami, Florida §Sound Pharmaceuticals, Seattle, Washington ||Hearing Science Program, Callier Center for Communication Disorders, Dallas, Texas.
authors: Kathleen
authors: K
authors: Campbell
authors: Tanisha
authors: T
authors: Hammill
authors: Michael
authors: M
authors: Hoffer
authors: Jonathan
authors: J
authors: Kil
authors: Colleen
authors: C
authors: Le Prell
mesh_terms: D000328:Adult; D001309:Auditory Threshold; D002986:Clinical Trials as Topic; D006320:Hearing Tests / Q000379:methods*; D006801:Humans; D008297:Male