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Purpose To evaluate the safety and performance of three novel vibroplasty couplers that allow attachment of the floating mass transducer of a transcutaneous active middle ear implant (AMEI) to the round window (RW) membrane, the long process (LP), or the incus body and the short process (SP) of the incus. Methods Retrospective multicenter cohort study of 25 AMEI users with sensorineural or mixed hearing loss that were among the first implanted with an AMEI vibrating ossicular prosthesis in combination with the third generation of vibroplasty couplers between 2014 and 2016. Main Outcome Measures were bone-conduction pure-tone and vibroplasty thresholds, postoperative aided sound field thresholds and postoperative aided word recognition score (WRS). Results Bone conduction threshold changes of more than 10 dB in 4PTABC were observed in two subjects. A mean improvement of 57.8% in speech recognition was observed with a mean WRS at 65 dB SPL improving from 14.8% (SD 21.9%) preoperatively to a mean aided score of 72.6% (SD 18.6%). Sound field thresholds improved from an average 4PTASF of 64.1 dB HL (SD 9.8 dB HL) to 37.0 dB HL (SD 8.9 dB HL), resulting in a mean functional gain of 27.1 dB. There was no significant difference in WRS or functional gain between the coupler types. Conclusion Initial experience shows that all three third generation vibroplasty couplers represent safe and efficient attachment options for the FMT allowing the surgeon to choose the coupling type based on the present pathology.

Objective: If mixed-hearing-loss (MHL) occurs in otosclerosis, hearing-aids (HA) in addition to conventional-stapedotomy (SDT) may be necessary. If otosclerosis progresses or technical or medical problems prevent use of HA, combining active-middle-ear-implants (AMEI) with SDT (“power-piston”) may be considered. Previously, AMEI-coupling to the long-incudial-process was suggested. Here, a “modified-power-piston” surgery (mPP) coupling to the short-incudial-process was proposed, so no coupling over the positioned stapes-piston is required. We questioned whether mPP is as safe and effective as SDT. Methods: Otosclerotic patients with MHL and limited satisfaction with previously worn HA receiving mPP were retrospectively reviewed at two Austrian tertiary otologic referral centers. Patients, receiving stapedotomy, were case-matched for preoperative pure-tone averages (PTA), bone-conduction (BC-PTA), air-conduction (AC-PTA), and air-bone gap (ABG-PTA). Postoperative changes in BC-PTA and in AC-PTA and ABG-PTA were defined as safety- and as efficacy outcome parameter. Results: Of 160 patients, 14 received mPP and 14 stapedotomy. Preoperative findings were comparable (all p = 1.000). BC-PTA improved from 38.0 to 36.7 and from 37.1 to 36.9 dB-HL for mPP and SDT, respectively (Δ –1.3 versus –0.2 dB-HL; p = 0.077). AC-PTA improved from 66.8 to 47.1 and from 66.3 to 46.5 dB-HL for mPP and SDT, respectively (Δ –19.6 versus –19.7 dB-HL; p = 0.991). ABG-PTA improved from 28.8 to 10.4 and from 29.1 to 9.6 dB-HL for mPP and SDT, respectively (Δ –18.3 versus –19.5 dB-HL; p = 0.771). Conclusion: In otosclerosis with MHL and limited satisfaction with HA, mPP appeared as safe and effective as SDT and may be considered a treatment alternative in these patients.

Objective To estimate the reliability of the Bone Conduction-HeadBand (BC-HB) test for predicting the postoperative functional outcome of a round-window (RW) vibroplasty. Study design Within-subject comparison of the functional results of the BC-HB test, which is routinely used for the preoperative evaluation of a bone-conduction transducer, with an active middle ear implant (AMEI) placed onto the round window. Setting Tertiary referral university hospital center. Patients Seven patients with similar anatomic (absent stapes superstructure) and functional (moderate, mixed hearing loss) sequelae from open tympanoplasty technique. Intervention All subjects underwent preoperative audiologic assessment with the BC-HB. Subsequently, all subjects underwent surgical placement of an AMEI onto the round window. Main outcome measure Pure tone and speech audiometry in quiet and noise were assessed. Additionally, evaluation of specific satisfactory targets was performed using the Client Oriented Scale of Improvement. Results Pure tone and speech audiometry in quiet established that both devices had very similar performance and provided remarkable improvement compared with the unaided condition. However, high-frequency gain and speech audiometry in noise demonstrated better performance with RW-AMEI. Conclusion In patients presenting with mixed hearing loss as a sequela from middle ear surgery, the preoperative BC-HB test may be helpful in predicting the final functional outcome and patient satisfaction with RW-AMEI.