Objective: To alleviate congenital high airway obstruction syndrome (CHAOS) from laryngeal atresia by percutaneous minimally-invasive fetoscopic tracheal decompression using laser. Methods: The procedure was performed via one trocar under general maternofetal anesthesia in a human fetus with CHAOS from laryngeal atresia at 21+6 weeks of gestation. Results: Normalization of the lung-heart size relationship was observed within days after the procedure. The fetus was delivered by ex utero intrapartum treatment (EXIT) in order to perform a tracheotomy at 31+1 weeks of gestation and survived hospital treatment to discharge. Conclusions: Percutaneous minimally-invasive fetoscopic decompression of the fetal trachea via a single trocar is feasible in human fetuses with CHAOS from laryngeal atresia.
Recently, we presented an implantable piezoelectrical hearing aid transducer. Its characteristics make it suitable for implantation in patients with sensorineural hearing loss. The transducer transmits micromechanical vibrations instead of sound into the hearing organ. Efficiency of the transducer implant was investigated in ten cat ears. After determining preoperative (acoustical) BERA threshold, the middle ear was opened and the piezoelectrical transducer coupled to various ossicles or the perilymph. BERA responses were recorded following stimulation of umbo, long incus process, stapes head, stapes foot plate, and vestibulum. By comparing the acoustical and mechanical threshold, a correlation was found between the stimulus level of acoustical and mechanical stimulation. An electrical transducer voltage of 1 Vrms was equivalent to sound-pressure levels between 100 and 128 dB SPL at the tympanic membrane. To judge hearing impression, stimulus-dependent latencies of the early acoustically and mechanically evoked potentials (waves P1 to P5) and their thresholds were analyzed. After coupling the piezoelectrical transducer to the long incus process, latencies corresponded well to stimulation. They were almost completely similar when the equivalent sound-pressure level of 100 dB SPL was achieved by the transducer voltage level.
During routine middle ear surgery prototypes of implantable piezoelectric hearing aid transducers were coupled to the ossicular chain of 28 patients. Pure tone thresholds in a broad frequency range (250 Hz-8 kHz) and perception of music were the basis of psychoacoustic evaluation of the transfer properties of the prototypes in this human study. The piezoelectric transducer reached an equivalent transducer sound-pressure level of up to 145 dB SPL and frequencies of 10 kHz. The dynamics for music reached 32 dB, which was identical with the results of the preoperative investigations using hi-fi headsets (33 dB). The low nonlinear distortions of around 0.1% and the frequency range up to 10 kHz are reflected in the positive evaluation of sound quality by 84% of the patients involved. The study is the basis for realizing a piezoelectric transducer designed for routine clinical implantations. The transducer is thought to be part of a totally implantable future hearing aid for rehabilitation of moderate and severe sensory neural hearing loss predominantly in the middle and high frequency range.
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