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The Phase 1b study, FX-322, was associated with a hearing signal, as shown by improvements by four subjects in a sentence-in-noise test.
In the FX-322-113 study, BKB-SIN test improvements were observed in four subjects, all of whom exceeded the 95% critical difference of 3.1 dB SNR, with two subjects showing a 6 dB response.
A single placebo patient had a 3.6 dB change.
In the study, subjects did not show substantial changes in speech perception measures in quiet. The safety profile in the study was favorable, and no treatment-related serious adverse events were reported.
BKB-SIN is a validated test designed for severe SNHL populations, measuring the change in signal-to-noise ratios required for a subject to correctly repeat words in a sentence.
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