TY - JOUR
T1 - Guidelines for Auditory Threshold Measurement for Significant Threshold Shift
AU - Campbell, Kathleen
AU - Hammill, Tanisha
AU - Hoffer, Michael E
AU - Kil, Jonathan
AU - Le Prell, Colleen
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
KW - Auditory
KW - Measurement
KW - Significant Threshold Shift
KW - STS
UR - http://www.scopus.com/inward/record.url?scp=84983335539&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84983335539&partnerID=8YFLogxK
U2 - 10.1097/MAO.0000000000001135
DO - 10.1097/MAO.0000000000001135
M3 - Article
C2 - 27518134
AN - SCOPUS:84983335539
VL - 37
SP - e263-e270
JO - Otology and Neurotology
JF - Otology and Neurotology
SN - 1531-7129
IS - 8
ER -