Abstract
Identify factors associated with benefit of middle ear implants (MEIs) as compared to conventional hearing aids (HAs). Independent review of audiological data from a multicenter prospective U.S. Food and Drug Administration (FDA) clinical trial. Preoperative and postoperative earphone, unaided/aided/implanted pure-tone thresholds, and word recognition scores were evaluated. Ninety-one subjects were included in this study. Mean word recognition was better with MEIs than with HAs (81.8% ± 12.0% vs. 77.6% ± 14.6%, P = 0.035). Word recognition with MEIs showed a low positive correlation with word recognition measured with earphones (r = 0.25, P = 0.016) and a moderate positive correlation with aided word recognition (r = 0.42, P < 0.001). Earphone word recognition alone was not predictive of MEI benefit over HA benefit (r = 0.09, P = 0.41), unlike differences between scores with earphone and HAs (earphone-aided differences [EAD]) (r = 0.62, P < 0.011). As compared to those with -EADs, subjects with +EADs showed greater improvement in word recognition from unaided to implanted and from HAs to implanted (P < 0.0001). Using the 95% CI for word recognition scores, 16 subjects showed significantly higher scores with the MEI than with HA...Continue Reading
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