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Otol Neurotol. 2015 Aug;36(7):1216-22. doi: 10.1097/MAO.0000000000000796.

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

Author information

1
*Department of Otorhinolaryngology and Plastic Operations, University Hospital Schleswig-Holstein, Lübeck, Germany; †Ear, Nose and Throat Department, Landesklinikum St. Pölten, St. Pölten, Austria; ‡Department of Otorhinolaryngology, Head & Neck Surgery, Franz Tappeiner Hospital, Meran, Italy; §Department of Otolaryngology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; and ∥Clinic and Policlinic for Ear Nose and Throat Treatment, University Clinic Grosshadern, Munich, Germany.

Abstract

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.

PMID:
26107139
DOI:
10.1097/MAO.0000000000000796
[Indexed for MEDLINE]

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