Table 1.

Clinical trial audiological exclusion criteria

Ingestion within the previous 2 months: Mefloquine, aminoglycoside antibiotics, halofantrine, artemether-lumefantrine.

Ingestion within the previous 2 weeks: Quinine, chloroquine, any other antimalarial drug, aspirin, loop diuretics, macrolide antibiotics.

History of any drug-related hearing impairment or prior middle or inner ear surgery.

Current ear infection or discharge.

Untreatable impaction of cerumen with occlusion of the external auditory canal.

Currently wearing a hearing aid.

Abnormal tympanometry in either or both ears defined as Type B (“flat”) or Type C (“negative”) with peak ear pressure more negative than −120 dPA; a static compliance outside the range of 0.3–1.4 mL was considered abnormal.

Abnormal audiogram: Pure-tone air conduction thresholds in either or both ears (≥ 25 dB at 3 contiguous frequencies) or aural asymmetry (≥ 25 dB right-left difference at any frequency or ≥ 20 dB right-left difference at 2 contiguous frequencies or ≥ 15 dB right-left difference at 3 contiguous frequencies).

Abnormal auditory brainstem response: Absence of identifiable, measurable waveforms (Wave I, III, and V) after 2 replicable runs in either or both ears or greater than 0.20 msec difference between the right and left ear Wave V latencies.

Unable to cooperate with testing.