Prospective, Monocentric, Repeated-Measures Study of ADHEAR in Adults with Middle Ear Disease

Objective: The aim of this study was to evaluate the audiological performance of the ADHEAR system and to compare it with a softband BAHA system in adults with middle ear disease. Study Design: Prospective, single-subject, repeated-measures study Setting: Monocentric study Participants: In 23 patients, with mild to moderate conductive hearing loss, the ADHEAR system was tested, where 8 of them were outside of the ADHEAR indication. In ten patients, testing was performed with the ADHEAR system and a softband BAHA system. A control group consisted of 10 patients with simulated bilateral conductive hearing loss. Main outcome measures: Air and bone conduction thresholds and free-field monosyllable speech intelligibility thresholds in quiet and in noise were measured in unaided and aided situation with the ADHEAR and a softband BCHD. Furthermore, ADHEAR questionnaire was assessed. Results: In patients with a middle ear disease compared to the unaided situation, the aided situations with the ADHEAR system and the softband BAHA system led to a significant improvement of speech intelligibility in quiet and in noise. Outside the device indication performance was limited. In terms of the ADHEAR questionnaire, using the ADHEAR system patients reported an improvement in sound quality and speech intelligibility. Conclusion: Due to the pressure-less wearing comfort we see the ADHEAR system as a treatment option in patients who are unable to receive or deny surgery. Outside of its indication use must be evaluated individually. Softband BAHA systems remain an alternative solution for patients with conductive hearing loss.