Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2015
The Vibrant Soundbridge in Children and Adolescents: Preliminary European Multicenter Results.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Frenzel Henning, Sprinzl Georg, Streitberger Christian, Stark Thomas, Wollenberg Barbara, Wolf-Magele Astrid, Giarbini Nadia, Strenger Tobias, Müller Joachim, Hempel John-Martin
Аннотация
OBJECTIVE: Evaluation of safety and efficacy of the Vibrant Soundbridge in the treatment of hearing loss in children and adolescents with primary focus on improvement in speech discrimination.
STUDY DESIGN: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control.
SETTING: Tertiary referral center.
PATIENTS: Nineteen patients aged 5 to 17 years.
INTERVENTION: Implantation of an active middle ear implant.
MAIN OUTCOME MEASURE: Improvement in word recognition scores, speech reception thresholds, and signal-to-noise ratios (SNRs) were evaluated, in addition to air and bone conduction. Oldenburger Kids Satztest/Oldenburger Satztest sentences and Göttinger/Freiburger monosyllables at 65-dB hearing level were tested in two age groups.
RESULTS: Significant speech discrimination improvement was seen in all patients after 6 months. In children 5 to 9 years old, mean monosyllable recognition improved from 28.9% (unaided) to 95.5% (Soundbridge-aided). Aided 50% sentence discrimination at 44.1 dB and SNR of -4.9 dB were measured. In patients 10 to 17 years old, mean word recognition improved from 18.5% to 89.0%, sentence reception threshold improved to 40.2 dB, and SNR to -3.6 dB. Comparison between age groups indicated a slight trend toward quicker adaptation by older subjects. However, after initial adjustment, a higher level of overall benefit was seen at 6 months in younger children.
CONCLUSIONS: Currently, the only middle ear implant approved for pediatric patients, the Vibrant Soundbridge, provides an option in cases of congenital aural atresia or disease-induced defects, when surgical intervention and reconstruction is indicated. The 6-month results in this comparatively large study population validated conclusions found in previous trials.
STUDY DESIGN: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control.
SETTING: Tertiary referral center.
PATIENTS: Nineteen patients aged 5 to 17 years.
INTERVENTION: Implantation of an active middle ear implant.
MAIN OUTCOME MEASURE: Improvement in word recognition scores, speech reception thresholds, and signal-to-noise ratios (SNRs) were evaluated, in addition to air and bone conduction. Oldenburger Kids Satztest/Oldenburger Satztest sentences and Göttinger/Freiburger monosyllables at 65-dB hearing level were tested in two age groups.
RESULTS: Significant speech discrimination improvement was seen in all patients after 6 months. In children 5 to 9 years old, mean monosyllable recognition improved from 28.9% (unaided) to 95.5% (Soundbridge-aided). Aided 50% sentence discrimination at 44.1 dB and SNR of -4.9 dB were measured. In patients 10 to 17 years old, mean word recognition improved from 18.5% to 89.0%, sentence reception threshold improved to 40.2 dB, and SNR to -3.6 dB. Comparison between age groups indicated a slight trend toward quicker adaptation by older subjects. However, after initial adjustment, a higher level of overall benefit was seen at 6 months in younger children.
CONCLUSIONS: Currently, the only middle ear implant approved for pediatric patients, the Vibrant Soundbridge, provides an option in cases of congenital aural atresia or disease-induced defects, when surgical intervention and reconstruction is indicated. The 6-month results in this comparatively large study population validated conclusions found in previous trials.
Предметные рубрики MeSH
AdolescentAge FactorsAudiometryBone ConductionChildChild, PreschoolCochlear ImplantationEuropeFemaleHearing LossHearing Loss, ConductiveHearing Loss, Mixed Conductive-SensorineuralHearing TestsHumansMaleOssicular ProsthesisProspective StudiesSignal-To-Noise RatioSpeech PerceptionSpeech Reception Threshold TestTreatment Outcome