100 Chapter 4.1 the requirement for a headband. It is comprised of a lightweight sound processor and an adhesive adapter pad placed onto the hairless postauricular skin directly over the mastoid bone. Early publications of the outcomes of use of this adhesive BC hearing system in adults with CHL demonstrated high levels of user satisfaction and no skin irritations [29], as well as comparable results to conventional softband devices with regards to speech understanding and sound localization [30]. In this study, we report the results of the first group ofpediatric patients with a CHL, to use an adhesive retained BC hearing aid system. The primary objective was to assess its audiological effectiveness when compared with the child’s unaided thresholds and those obtained with a BC hearing aid worn on a softband. Secondary objectives were to assess the quality-of-lifeimpact after using the adhesive hearing system for a minimum of 4 weeks including the evaluation of the day-to-day practicalities of using this novel hearing device. 2. Methods 2.1 Study Design A prospective, single-subject, repeat measure, cohort study in which each participant served as their own control. Following ethical approval through the NHS Research Authority (Ref 17/ LO/0588, IRAS project ID 217184) participants were recruited from the patient body at Birmingham Children’s Hospital. 2.2 Patients Twenty-one subjects with 22 devices completed the study. Twenty patients had a unilateral CHL and 1 patient was bilateral. Participants were aged between 5 and 15 years with conductive hearing loss greater than or equal to 25 dB HL in the better hearing cochlea. Participants were required to have previous experience using transcutaneous bone conduction hearing systems and to be native English speakers. Patients were excluded from the study if there was evidence of fluctuation of hearing loss over a 2-year period of 15 dB in either direction, nonresponsive active ear infection and/or chronic fluid in or about the ear, retrocochlear or central auditory disorders, masking problems in audiometric free field tests and any physical, psychological, or emotional disorder that would interfere with the ability to perform testing and engage in rehabilitation procedures. Informed written consent was obtained before enrollment.
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