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

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.

• Authors: Henning Frenzel, Georg Sprinzl, Christian Streitberger, Thomas Stark, Barbara Wollenberg, Astrid Wolf-Magele, Nadia Giarbini, Tobias Strenger, Joachim Müller, John-Martin Hempel
• Journal: Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology (Otol Neurotol) Vol. 36 Issue 7 Pg. 1216-22 (Aug 2015) ISSN: 1537-4505 [Electronic] United States
• PMID: 26107139 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Topics

• Adolescent
• Age Factors
• Audiometry
• Bone Conduction
• Child
• Child, Preschool
• Cochlear Implantation
• Europe
• Female
• Hearing Loss (surgery)
• Hearing Loss, Conductive (surgery)
• Hearing Loss, Mixed Conductive-Sensorineural (surgery)
• Hearing Tests
• Humans
• Male
• Ossicular Prosthesis
• Prospective Studies
• Signal-To-Noise Ratio
• Speech Perception
• Speech Reception Threshold Test
• Treatment Outcome