Lefebvre P P, Martin C, Dubreuil C, Decat M, Yazbeck A, Kasic J, Tringali S
Department of Otorhinolaryngology, University of Liège, BE-4000 Liège, Belgium.
Audiol Neurootol. 2009;14(3):172-80. doi: 10.1159/000171479. Epub 2008 Nov 13.
The safety and performance of the Otologics fully implantable hearing device were assessed in adult patients with mixed conductive and sensorineural hearing loss.
The subcutaneous microphone of this fully implantable device picks up ambient sounds, converts them into an electrical signal, amplifies the signal according to the user's needs, and sends it to an electromechanical transducer. The transducer tip is customized with a prosthesis in order to be in contact with the round window membrane and is protected by fascia; this translates the electrical signal into a mechanical motion that directly stimulates the round window membrane and enables the user to perceive sound. The implanted battery is recharged daily via an external charger and the user can turn the implant on and off as well as adjust the volume with a hand-held remote control. In this pilot study, 6 patients with mixed conductive and sensorineural hearing loss were implanted with the Otologics fully implantable hearing device. Pre- and postoperative air conduction, bone conduction, as well as aided and unaided thresholds and speech scores were measured.
No significant differences between preoperative and postoperative pure-tone averages were noted. Average improvement ranged from 19.16 to 35.8 dB of functional gain across audiometric frequencies with a mean of 26.17 +/- 5.15 dB. Long-term average functional gain at 12 months was 20.83 +/- 6.22 dB. Word recognition scores demonstrated significant differences between unaided and implant-aided conditions.
Preliminary results of this trial of the Otologics fully implantable hearing device provide evidence that this fully implantable device is capable of efficiently transferring the sound to the inner ear via the round window membrane in patients with mixed hearing loss.
在患有混合性传导性和感音神经性听力损失的成年患者中评估Otologics完全植入式听力装置的安全性和性能。
这种完全植入式装置的皮下麦克风接收周围声音，将其转换为电信号，根据用户需求放大信号，然后将其发送到一个机电换能器。换能器尖端定制有假体，以便与圆窗膜接触，并由筋膜保护；这将电信号转换为机械运动，直接刺激圆窗膜，使用户能够感知声音。植入的电池通过外部充电器每天充电，用户可以通过手持遥控器打开和关闭植入装置以及调节音量。在这项初步研究中，6例患有混合性传导性和感音神经性听力损失的患者植入了Otologics完全植入式听力装置。测量了术前和术后的气导、骨导以及助听和未助听阈值和言语得分。
术前和术后纯音平均值之间未发现显著差异。在听力计各频率上，平均功能增益改善范围为19.16至35.8 dB，平均为26.17±5.15 dB。12个月时的长期平均功能增益为20.83±6.22 dB。单词识别得分在未助听和植入助听条件之间显示出显著差异。
Otologics完全植入式听力装置的这项试验的初步结果提供了证据，表明这种完全植入式装置能够在混合性听力损失患者中通过圆窗膜有效地将声音传递到内耳。
