Favoreel Amelia, Heuninck Emilie, Mansbach Anne-Laure
Otorhinolaryngology Department, Queen Fabiola Children's University Hospital, Avenue Jean-Joseph Crocq 15, 1020, Brussels, Belgium.
Otorhinolaryngology Department, Queen Fabiola Children's University Hospital, Avenue Jean-Joseph Crocq 15, 1020, Brussels, Belgium.
Int J Pediatr Otorhinolaryngol. 2020 Feb;129:109729. doi: 10.1016/j.ijporl.2019.109729. Epub 2019 Oct 15.
The main objective of this study was to evaluate the audiological benefit of the ADHEAR system in a group of children with a uni- or bilateral conductive hearing loss (CHL) during a short-term exposure of three weeks, and to compare it to a conventional bone conduction hearing aid (BCHA) on a softband. The secondary aim was to assess the quality of life improvement and patient satisfaction with the ADHEAR system.
The study was designed as a prospective study with repeated measures, where each subject served as his/her own control. Ten children (4-17 y/o) with a uni- or bilateral congenital or acquired CHL were included in this study. Pure tone audiometry and speech audiometry in quiet, both unaided and aided, were performed initially with the ADHEAR system and a BCHA on a softband, and after three weeks with the ADHEAR alone. Furthermore, patient satisfaction and quality of life were assessed using the SSQ12 and the ADHEAR questionnaire.
The mean unaided free field hearing threshold of 50 dB HL (with 95%CI between 41.7 and 57.5 dB HL) expressed in 'Bureau International d'Audiophonologie' (BIAP), improved significantly by 22 dB (13.0-29.9) with the ADHEAR and by 23 dB (13.6-32.9) with the BCHA (p < 0.001). Furthermore, the mean unaided speech recognition threshold (SRT) in quiet improved significantly by 19 dB (10.3-28.1) with the ADHEAR and by 21 dB (12.6-29.4) with the BCHA (p < 0.001). For both audiological tests, there were no significant differences between the ADHEAR and the BCHA. After three weeks of use, the mean pure tone threshold of 28 dB HL (20.0-36.5) and the mean SRT of 47 dB SPL (41.9-51.5) with the ADHEAR system were comparable and not significantly different than the outcomes during the first visit. Speech understanding in noise and in multiple streams, sound localization and sound quality were rated significantly better with the ADHEAR, compared to the ratings without the ADHEAR system (p < 0.001). None of the children reported skin irritations or pain.
The children included in our study had significantly improved hearing thresholds, speech perception in quiet and quality of life with the ADHEAR. The device can be an effective treatment method and a valuable alternative to other BCHA for children with a CHL, although the subjective experience of each child has to be taken into account.
NCT03327194.
本研究的主要目的是评估ADHEAR系统在一组单侧或双侧传导性听力损失（CHL）儿童中进行为期三周的短期使用时的听觉益处，并将其与传统软带骨传导助听器（BCHA）进行比较。次要目的是评估ADHEAR系统对生活质量的改善情况以及患者满意度。
本研究设计为一项采用重复测量的前瞻性研究，每个受试者均作为自身对照。本研究纳入了10名年龄在4至17岁之间的单侧或双侧先天性或后天性CHL儿童。最初使用ADHEAR系统和软带BCHA进行纯音听力测试和安静环境下的言语听力测试（包括未佩戴辅助设备和佩戴辅助设备时），三周后仅使用ADHEAR进行测试。此外，使用SSQ12和ADHEAR问卷评估患者满意度和生活质量。
以“国际听力学协会”（BIAP）表示的平均未佩戴辅助设备时的自由声场听力阈值为50 dB HL（95%置信区间在41.7至57.5 dB HL之间），使用ADHEAR时显著改善了22 dB（13.0至29.9），使用BCHA时改善了23 dB（13.6至32.9）（p < 0.001）。此外，安静环境下平均未佩戴辅助设备时的言语识别阈值（SRT）使用ADHEAR时显著改善了19 dB（10.3至28.1），使用BCHA时改善了21 dB（12.6至29.4）（p < 0.001）。对于这两项听力测试，ADHEAR和BCHA之间无显著差异。使用三周后，ADHEAR系统的平均纯音阈值为28 dB HL（20.0至36.5），平均SRT为47 dB SPL（41.9至51.5），与首次就诊时的结果相当且无显著差异。与未使用ADHEAR系统时相比，ADHEAR在噪声和多声源环境下的言语理解、声音定位和声音质量方面的评分显著更高（p < 0.001）。没有儿童报告皮肤刺激或疼痛。
我们研究中的儿童使用ADHEAR后听力阈值、安静环境下的言语感知和生活质量均有显著改善。对于CHL儿童，该设备可以是一种有效的治疗方法，也是其他BCHA的有价值替代方案，不过必须考虑每个儿童的主观体验。
NCT03327194。
