The Vibrant Soundbridge in Children and Adolescents: Preliminary European Multicenter Results.

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.