Table 1.

Operationalization of the Red Flags for the Current Study

FDA Red Flags	Key criteria used in chart review
Visible congenital or traumatic deformity of the ear.	Search for “deformity,” or “malformation,” of the “pinna”, or “external ear”.
History of active drainage from the ear within the previous 90 days.	Search for “drain,” “pus,” or “otorrhea.”
History of sudden or rapidly progressive hearing loss within the previous 90 days.	Search for “sudden,” “rapid,” “acute,” and “hearing loss” within 90 days.
Acute or chronic dizziness.	Search for “dizziness,” or “vertigo.”
Unilateral hearing loss of sudden or recent onset within the previous 90 days.	Search for “unilateral” or “asymmetric” within 90 days.
Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz.*	Calculate air-bone gap at 500 Hz, 1000 Hz, and 2000 Hz, then calculate the average.
Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.	Search for “blockage,” “foreign,” “debris,” “object,” “cerumen obstructing clear view of the tympanic membrane,” or “wax obstructing clear view of the tympanic membrane”, “impaction”
Pain or discomfort in the ear.*	Search for “pain,” “discomfort,” “fullness,” “pressure,” or “otalgia.”
AAO-HNS Red Flags
Hearing loss with a positive history of ear infections, noise exposure, familial hearing loss, TB, syphilis, HIV, Meniere’s disease, autoimmune disorder, ototoxic medication use, otosclerosis, von Recklinghausen’s neurofibromatosis, Paget’s disease of bone, ear or head trauma related to onset.	Hearing loss as PTA.5, 1, 2 kHz > 20 dB HL, and search for “noise,” “familial/family,” “TB/tuberculosis,” “syphilis,” “HIV/AIDS,” “Meniere’s,” “autoimmune,” “ototoxic,” “otosclerosis,” “Recklinghausen,” “neurofibromatosis,” “Paget,” or “trauma”
History of pain, active drainage, or bleeding from an ear.*	Search for “pain,” “discomfort,” “pressure,” “fullness,” “otalgia,” “drain/drainage,” “blood,” “bleeding,” “pus,” or “otorrhea.”
Sudden onset or rapidly progressive hearing loss.	Search for “sudden,” “rapid,” or “acute.”
Acute, chronic, or recurrent episodes of dizziness.	Search for “dizziness” or “vertigo.”
Evidence of congenital or traumatic deformity of the ear.	Search for “deformity,” or “malformation,” of the “pinna”, or “external ear”.
Visualization of blood, pus, cerumen plug, foreign body, or other material in the ear canal.	Search for “blood,” “bleeding,” “pus,” “blockage,” “foreign,” “debris,” “object,” “cerumen,” or “wax.”
An unexplained conductive hearing loss or abnormal tympanogram.	Tympanograms with pressure < −100 daPa, or classified as type “B” or “C.”
Unilateral or asymmetric hearing loss (a difference of greater than 15 dB Pure Tone Average between ears); or bilateral hearing loss > 30 dB.*	Calculated PTA.5,1,2 kHz for each ear and subtracted. For bilateral, flagged if both ears’ PTA > 30 dB HL.
Unilateral or pulsatile tinnitus.	Search for “tinnitus” with “pulsatile” or “unilateral.”
Unilateral or asymmetrically poor speech discrimination scores (a difference of greater than 15% between ears); or bilateral speech discrimination scores <80%.	Examine scores from NU-6 for each ear and subtract. For bilateral, flagged if both ears’ speech scores were < 80%.

^*Alternate operationalizations were attempted for these red flags, which resulted in moderate changes to the sensitivity and specificity. The authors finalized the analysis using the descriptions listed in the table.