“…Safety of the device was assessed by collecting information on complications during surgery and adverse events in the postoperative period (S4 and S5 Tables). Twenty-five [16, 26, 27, 6, 7, 29, 24, 30, 8–10, 31, 11, 25, 17, 33, 18, 13, 35, 36, 14, 38, 15, 21, 46] publications out of the 39 identified citations reported on complications and adverse events, out of which ten citations (n = 259; 90.6%), explicitly stated that no complications occurred during the full study period [16, 27, 30, 10, 31, 11, 25, 38, 15, 21]. A total of 286 ears were evaluated for safety outcomes over a mean follow-up period of 11.7±4.5 months (range: 3–36 months).…”