Di Berardino Federica, Ciavarro Giovanni, Fumagalli Giulia, Albanese Claudia, Pasanisi Enrico, Zanetti Diego, Vincenti Vincenzo
Department of Clinical Sciences and Community Health, University of Milan, 20122 Milan, Italy.
Audiology Unit, Department of Surgical Sciences, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, 20122 Milan, Italy.
Audiol Res. 2024 Oct 11;14(5):893-902. doi: 10.3390/audiolres14050075.
This study aimed to compare the audiological benefits of a non-implantable wearable option for a bone conduction (BC) implant mounted on an arch (SoundArc) to those of traditional BC hearing aids (HAs) mounted on eyeglasses (BCHAs) in patients with moderate to severe conductive or mixed hearing loss.
A preliminary cross-sectional observational prospective cohort study was conducted in the Tertiary Audiological Department, University Hospital. Fourteen adults with conductive or mixed hearing loss (PTA at 0.5-1-2-4 KHz = 67 ± 15 dB HL) who had been wearing conventional BCHAs mounted on eyeglasses for at least 3 years and had declined surgical implantation of a bone conduction hearing implant (BCHI) were included in the study. Unaided and aided pure-tone air conduction (AC) and bone conduction (BC) thresholds, as well as speech tests in quiet and noise, were recorded at baseline and in two different settings: with a BCHI mounted on SoundArc and with their own BCHAs mounted on eyeglasses using two couplers. Participants completed questionnaires in both conditions, including the International Inventory for Hearing Aids (IOI-HA), the Hearing Handicap Inventory for Adults/Elderly (HHIA/E), the Speech, Spatial, and Qualities of Hearing Scale (SSQ), a 10-point visual analog scale (VAS), and the Fatigue Impact Scale (FIS).
A significant functional gain was observed in both settings ( = 0.0001). Better speech perception in quiet and noise was observed with SoundArc compared to conventional BCHAs on eyeglasses (improvements in word repetition scores in noise: +19.3 at SNR +10 dB, = 0.002; +12.1 at SNR 0 dB, = 0.006; and +11.4 at SNR -10 dB, = 0.002). No significant differences were found in IOI-HA, FIS, and HHIA/E scores. However, significantly better SSQ scores were reported for SoundArc in all domains ( = 0.0038).
Although patients were accustomed to using BCHAs mounted on eyeglasses, the bone conduction wearable option of the BCHI (SoundArc) proved to be a viable alternative for adult patients with conductive or mixed hearing loss who are unable or unwilling to undergo BCHI surgery.
本研究旨在比较安装在牙弓上的骨传导（BC）植入物的非植入式可穿戴设备（SoundArc）与安装在眼镜上的传统BC助听器（BCHA）对中度至重度传导性或混合性听力损失患者的听力益处。
在大学医院的三级听力科进行了一项初步的横断面观察性前瞻性队列研究。纳入了14名患有传导性或混合性听力损失的成年人（0.5-1-2-4kHz的纯音平均听阈 = 67±15dB HL），他们佩戴安装在眼镜上的传统BCHA至少3年，并且拒绝接受骨传导听力植入物（BCHI）的手术植入。在基线以及两种不同情况下记录了未佩戴助听器和佩戴助听器时的纯音气导（AC）和骨导（BC）阈值，以及安静和噪声环境下的言语测试：一种情况是将BCHI安装在SoundArc上，另一种情况是使用两个耦合器将他们自己的BCHA安装在眼镜上。参与者在两种情况下都完成了问卷，包括国际助听器清单（IOI-HA）、成人/老年人听力障碍清单（HHIA/E）、言语、空间和听力质量量表（SSQ）、10分视觉模拟量表（VAS）和疲劳影响量表（FIS）。
在两种情况下均观察到显著的功能增益（P = 0.0001）。与安装在眼镜上的传统BCHA相比，SoundArc在安静和噪声环境下的言语感知更好（噪声中单词重复分数的改善：在信噪比为+10dB时提高19.³，P = 0.002；在信噪比为0dB时提高12.1，P = 0.006；在信噪比为 - 10dB时提高11.4，P = 0.002）。在IOI-HA、FIS和HHIA/E分数方面未发现显著差异。然而，SoundArc在所有领域的SSQ分数均显著更高（P = 0.0038）。
尽管患者习惯于使用安装在眼镜上的BCHA，但BCHI的骨传导可穿戴设备（SoundArc）被证明是无法或不愿接受BCHI手术的传导性或混合性听力损失成年患者的可行替代方案。
