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Material and Methods: Six patients undergoing exploratory tympanoto-  Objectives/Hypothetis: To review hearing results and complications for
            my for congenital conductve hearing loss or failed stapes surgery and requir-  the NiTiBOND next generation shape memory prosthesis and compare
            ing malleovestibulopexy are included in this study. Extended tympanomeatal   them with results for the current shape memory prosthesis (SMart). Study
            flap was employed for exposure of middle ear and upper malleus handle. The   Design: Retrospective, multicenter chart review.
            prosthesis was introduced and the clip was slipped on malleus handle. Minor
            adjustments were required to attain the perpendicularity of the shaft and shaft   Methods:  Primary laser stapedotomy was performed using either a
            insertion in the vestibule. Drilling of handle with diamond burr was required   NiTiBOND or a SMart prosthesis. Ninety-two ears in 79 patients were
            in half the cases to better adapt the clip on malleus handle.   included in the study (67.4% female), 52 with the NiTiBOND prosthesis
                                                                 and 40 with the SMart prosthesis. Data collected included demograph-
            Results: The mean of air-bone gap averaged over speech frequencies was   ic variables, pre- and postoperative pure-tone air and bone conduction
            within 20 dB in all six cases and within 10 dB in four cases. No deteriora-  thresholds, speech discrimination scores, complications, and the need for
            tion of bone conduction threshold was observed.      revision surgery. Pure-tone average (PTA) and PTA air-bone gap (ABG)
                                                                 pre- and postoperative were computed. Success was defined as a postop-
            Conclusions: The hearing resuts of malleovestibulopexy using newly in-  erative ABG of ≤10 dB.
            troduced titanium MVP clip prosthesis have been encouraging and almost
            equal results of stapes surgery. The improved results seem to be consequent   Results: There  were  no  significant  differences  between  groups  in  hear-
            to the unique design of the prosthesis which factors in two key variables of   ing results, including improvement in ABG, change in speech discrimina-
            this procedure viz anchorage of prosthesis on malleus handle and perpen-  tion, change in air or bone PTA, or change in high-frequency bone PTA.
            dicularity of the prosthesis shaft in relation to stapes footplate.   Short-term (mean = 4.4 and 4.9 weeks, respectively) success rates for the
                                                                 NiTiBOND and SMart prostheses were 84.6% and 70.0%, respectively,
                                                                 with this difference closing at the most recent test (83.7% and 80.0%,
            Laser doppler vibrometry data of the Clip piston MVP   respectively). No revision surgery took place in either group, and there
                                                                 were no differences in complications such as dizziness, tinnitus, or taste
            Arnold A., Stieger CH., Häusler R.                   disturbance, though the NiTiBOND group tended to have a lower rate of
                                                                 transient or permanent vertigo.
            Published: MEMRO 2006, 4th International Symposium on Middle Ear
            Mechanics in Research and Otology: Selected Abstracts  Conclusions: Compared with the SMart prosthesis, the NiTiBOND pros-
                                                                 thesis is a safe prosthesis that achieves at least comparable hearing results
            Background: A new malleus handle prosthesis for malleo-vestibulopexy   and may offer some surgical advantages.
            and revision stapedotomy has been developed at our departement and
            successfully used during the last five years. The piston prosthesis bears
            the CliP®-mechanism to facilitate attachment to the malleus handle and   How to Avoid a Learning Curve in Stapedotomy:
            length and position can easily be adjusted intraoperatively with a movable   A Standardized Surgical Technique
            hinge.
                                                                 Kwok P., Gleich O., Dalles K, Mayr E., Jacob P., Strutz J.
            Objective: The study was devised to determine if the special developed
            hinge of the CliP Piston MVP causes a loss of sound transfer from the mal-  Published: Otology & Neurotology 2017 Aug;38(7):931-937.
            leus grip to the vestibulum.                         DOI: 10.1097/MAO.0000000000001475

            Methods: A middle ear model was set up, consisting of a vibrator normally   Objective: To evaluate, whether a learning curve for beginners in stapedoto-
            used in an active implantable hearing device with a metal arm in shape and   my can be avoided by using a prosthesis with thermal memory-shape attach-
            dimension of an actual malleus handle, where the CliP Piston MVP was at-  ment in combination with a standardized laser-assisted surgical technique.
            tached with the hinge bend to an angle of about 120°. The piston end of the
            prosthesis dipped in a hole of a plastic container filled with water simulating   Study Design: Retrospective case review. Setting: Tertiary referral center.
            a piston hole in the footplate. The excitation level corresponded to more than   Patients: Fifty-eight ears were operated by three experienced surgeons and
            110 dB SPL for frequencies between 100 Hz – 10000 Hz. With a laser dop-  compared with a group of 12 cases operated by a beginner in stapedotomy.
            pler vibrometer the movements were picked up at different spots in the area   Intervention: Stapedotomy. Main Outcome Measures: Difference of pure-
            of the clip, the hinge and the piston.               tone audiometry thresholds measured before and after surgery.
            Results:  The overall characteristics of the transferfunction was practi-  Results: The average postoperative gain for air conduction in the frequen-
            cally identical (difference < 3dB). Additionally biphasic resonance peaks     cies below 2 kHz was 20 to 25 dB and decreased for the higher frequen-
            (5-10 dB) were observed around 1000 Hz.              cies. Using the Mann-Whitney-U test for comparing mean gain between
                                                                 experienced and inexperienced surgeons showed no significant difference
            Discussion: Our results show very stable transfer properties over the fre-  (p = 0.281 at 4 kHz and p > 0.7 for the other frequencies). A Spearman rank
            quency band. The noticed resonance peaks of 5-10 dB are very probably   correlation of the postoperative gain for air- and bone-conduction thresh-
            below significance level in clinical pure tone audiometry. This is in accor-  olds was obtained at each test frequency for the first 12 patients consecu-
            dance with our experience from clinical practice.    tively treated with a thermal memory-shape attachment prosthesis by two
                                                                 experienced and one inexperienced surgeon. This analysis does not support
            Conclusion: The CliP Piston MVP provides good transfer characteristics   the hypothesis of a "learning effect" that should be associated with an im-
            from the malleus handle to the vestibulum.           proved outcome for successively treated patients.
                                                                 Conclusion: It is possible to avoid a learning curve in stapes surgery by ap-
                                                                 plying a thermal memory-shape prosthesis in a standardized laser-assisted
                                NITIBOND                         surgical procedure.


            Next generation shape memory prosthesis (NiTiBOND)   Early functional results using the NiTiBOND  prosthesis
                                                                                                  ®
            for stapedotomy: Short-term results                  in stapes surgery
            Green J.D. Jr, McElveen J.T. Jr.                     Canu G., Lauretani F., Russo F. Y., Ferrary E., Lamas G.,
                                                                 Sterkers O., De Seta D., Bernardeschi D.
            Published: Laryngoscope. 2017 Apr;127(4):915-920.
            DOI: 10.1002/lary.26114                              Published: Acta Otolaryngol. 2016 Nov 4:1-6
                                                                 DOI 10.1080/00016489.2016.1247499

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