Factors associated with benefit of active middle ear implants compared to conventional hearing aids.

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 HAs. Of those, 14 had +EAD. Word recognition benefit derived from conventional HAs and MEIs from this large, multi-center FDA trial provides further evidence of the importance of aided word recognition in clinical decision making, such as determining candidacy for and success with MEIs. 2b. Laryngoscope, 128:2133-2138, 2018.