Clinical Trials

Inclusion Criteria:

• Normal otoscopic visualization of both ears, including clear external auditory canals and visible tympanic membranes and associated landmarks (e.g., cone-of-light, long arm of manubrium, etc.).
• Normal pure-tone hearing sensitivity (25 dB HL or better) across all octave frequencies (250 Hz through 8000 Hz) as well as for interoctave frequencies.
• Tympanometry within normal limits for middle ear pressure (+100 through -150 daPa), tympanic membrane compliance (0.3 through 1.7 mmho), and ear canal volume (0.2 through 2.0 ml), qualified as Jerger Type A tympanograms, in both ears.
• Ipsilateral and contralateral acoustic reflex threshold patterns that do not indicate the presence of auditory neuropathy spectrum disorder (ANSD). A pattern consistent with ANSD would be elevated and/or absent acoustic reflex thresholds across all conditions and test frequencies in both ears.
• Present distortion-product otoacoustic emissions (DPOAE) from 1000 Hz through 8000 Hz, bilaterally.

Exclusion Criteria: 

• Abnormal appearance of one or both external auditory canal(s) and/or tympanic membrane(s) on otoscopic examination.
• Presence of any degree (mild, moderate, moderately severe, severe, or profound), type (conductive, sensorineural, or mixed), and configuration (shape) of hearing loss.
• Tympanometry in one or both ears that is abnormal for middle ear pressure (exceeding either +100 or -150 daPa), tympanic membrane compliance (below 0.3 or above 1.7 mmho), and/or ear canal volume (less than 0.2 or greater than 2.0 ml). This includes tympanograms described as As, Ad, B, and C.
• Ipsilateral and contralateral acoustic reflex threshold patterns that indicate the presence of ANSD (i.e., elevated and/or absent acoustic reflex thresholds across all conditions and test frequencies in both ears).
• Absent DPOAEs for any frequency measured between 1000 Hz through 8000 Hz for either ear.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/14/23. Questions regarding updates should be directed to the study team contact.