TABLE 2.

Ototoxicity and hearing loss (composite) definitions^a

Term	Hearing loss	No hearing loss	Unable to classify
Ototoxicity	A significant deterioration (as determined by ASHA criteria) between an audiogram performed before or during therapy and one performed later during therapy or after completion of therapy in the presence of normal tympanogramsb	A normal audiogram in the last month or after completion of injectable therapyb; no significant deterioration (as determined by ASHA criteria) between an audiogram performed in the last month or after injectable therapy stopped and one performed within the first month of therapyb; no significant deterioration (ASHA criteria) between an audiogram performed after 365 days of injectable therapy and one performed within the first month of therapy	An abnormal audiogram without an earlier audiogram for comparisonb; a normal final audiogram before the last month of therapy (unless it was performed after 365 days on therapy)
Hearing loss (composite)	As for ototoxicity; a clinical report of new hearing impairment or tinnitus during or after therapy with an injectable agent in association with an abnormal audiogram; no prior audiogram required; a clinical report of new hearing impairment or tinnitus during or after therapy with an injectable agent in association with a significant deterioration (as determined by ASHA criteria) between an audiogram performed before or during therapy and one performed later during therapy or after completion of therapy above the 8-kHz range	No report of hearing impairment or tinnitus and the hearing loss does not fit the criteria for ototoxicity; a clinical report of new hearing impairment or tinnitus during or after therapy with an injectable agent in association with a normal audiogram or no deterioration in audiograms performed within a month of starting and at the time of or after the onset of symptoms	Unable to report symptoms (the patient was intubated or had extreme psychosis) or a full set of medical or nursing notes was missing
Worsening ototoxicity after stopping injectable agent	A significant deterioration (as determined by ASHA criteria) between an audiogram performed 30 days or more after the end of injectable therapy and one performed in the month before the end of therapy or on the stop date	No significant deterioration (as determined by ASHA criteria) between an audiogram performed 30 days or more after the end of injectable therapy and one performed in the month before the end of therapy or on the stop date	Any case not fitting either of the definitions

^aPTA, pure-tone audiometry; normal audiogram, ability to hear all frequencies above 25 dB; abnormal audiogram, an abnormal audiogram according to the criteria of the American Speech-Language-Hearing Association (ASHA).

^bBased on definitions of hearing loss proposed by Seddon et al. (9).