Hope for patients suffering from acute acoustic trauma or sudden deafness

Auris Medical announced that enrolment has been completed for its phase IIb clinical trial with AM-111 for the treatment of acute sensorineural hearing loss (ASNHL). A total of 210 patients were enrolled in the study to receive a single dose intratympanic injection of either AM-111 at 0.4 or 2 mg/ml or placebo. The study recruited patients suffering from acute acoustic trauma or sudden deafness with a mean hearing loss of at least 30 dB in 3 contiguous frequencies within the first 48 hours following the incident. Results from the AM-111 trial are expected to become available in fall 2012.

 

Acute sensorineural hearing loss may be the consequence of various insults to the cochlea. It may result e.g. from overexposure to noise, bacterial or viral infections, inflammation, vascular compromise, or a variety of other factors. In ASNHL, sensorineural structures of the inner ear – inner and outer hair cells, neurons – are damaged, as well as other structures such as supporting cells or vascular tissues. The common observation is a temporary increase in hearing thresholds, i.e. hearing loss. Thanks to cellular defences and intrinsic re-pair mechanisms, a certain amount of such hearing loss is frequently recovered in the subsequent days and weeks. The remaining hearing loss however is irreversible. ASNHL may be accompanied by other disorders of the inner ear such as dizziness or tinnitus.

 

When ASNHL develops into permanent hearing loss, it may have chronically debilitating consequences. Hearing loss may have serious impacts on professional and personal lives, e.g. through avoidance or with-drawal from social situations, reduced alertness and increased risk to personal safety, impaired memory and ability to learn new tasks, or reduced job performance and earning power. To date, there exists no treatment for ASNHL with proven efficacy.