Audiological benefit and subjective satisfaction of children with the ADHEAR audio processor and adhesive adapter

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.